title: A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of Edoxaban (DU-176b) Versus Warfarin In Subjects With Atrial Fibrillation - Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation (ENGAGE - AF TIMI - 48)

summary: This study is to demonstrate the safety and efficacy profile, in two different dose regimens of Edoxaban (DU-176b), (an investigational new drug being tested for the prevention of stroke/systemic embolic events (SEE)), in individuals with atrial fibrillation. Patients will be randomized to one of three treatment groups: High Dose Regimen, Low Dose Regimen, & Warfarin. The expected duration of the study is 24 months.

ReferenceCitation: Oyama K, Giugliano RP, Berg DD, Ruff CT, Jarolim P, Tang M, Murphy SA, Lanz HJ, Grosso MA, Antman EM, Braunwald E, Morrow DA. Serial assessment of biomarkers and the risk of stroke or systemic embolism and bleeding in patients with atrial fibrillation in the ENGAGE AF-TIMI 48 trial. Eur Heart J. 2021 May 1;42(17):1698-1706. doi: 10.1093/eurheartj/ehab141.

name: TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women’s Hospital, Harvard Medical School, 60 Fenwood Road, Suite 7022, Boston, MA 02115, USA

name: Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan

family: Oyama

full_name: Kazuma Oyama

given: Kazuma

family: Giugliano

full_name: Robert P Giugliano

given: Robert P

family: Berg

full_name: David D Berg

given: David D

family: Ruff

full_name: Christian T Ruff

given: Christian T

name: Division of Pathology, Brigham and Women’s Hospital, Harvard Medical School, 75 Francis Street, Boston, MA 02115, USA

family: Jarolim

full_name: Petr Jarolim

given: Petr

family: Tang

full_name: Minao Tang

given: Minao

family: Murphy

full_name: Sabina A Murphy

given: Sabina A

name: Daiichi Sankyo, Zielstattstraße 48, München 81379, Germany

family: Lanz

full_name: Hans J Lanz

given: Hans J

name: Daiichi Sankyo, 211 Mt Airy Rd, Basking Ridge, NJ 07920, USA

family: Grosso

full_name: Michael A Grosso

given: Michael A

family: Antman

full_name: Elliott M Antman

given: Elliott M

family: Braunwald

full_name: Eugene Braunwald

given: Eugene

family: Morrow

full_name: David A Morrow

given: David A

journal_name: European Heart Journal

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Steffel J, Ruff CT, Yin O, Braunwald E, Park JG, Murphy SA, Connolly S, Antman EM, Giugliano RP. Randomized, Double-Blind Comparison of Half-Dose Versus Full-Dose Edoxaban in 14,014 Patients With Atrial Fibrillation. J Am Coll Cardiol. 2021 Mar 9;77(9):1197-1207. doi: 10.1016/j.jacc.2020.12.053.

family: Steffel

full_name: Jan Steffel

given: Jan

full_name: Christian T. Ruff

given: Christian T.

family: Yin

full_name: Ophelia Yin

given: Ophelia

family: Park

full_name: Jeong-Gun Park

given: Jeong-Gun

full_name: Sabina A. Murphy

given: Sabina A.

family: Connolly

full_name: Stuart Connolly

given: Stuart

full_name: Elliott M. Antman

given: Elliott M.

full_name: Robert P. Giugliano

given: Robert P.

journal_name: Journal of the American College of Cardiology

ReferenceCitation: Wilkinson C, Wu J, Searle SD, Todd O, Hall M, Kunadian V, Clegg A, Rockwood K, Gale CP. Clinical outcomes in patients with atrial fibrillation and frailty: insights from the ENGAGE AF-TIMI 48 trial. BMC Med. 2020 Dec 24;18(1):401. doi: 10.1186/s12916-020-01870-w.

repository_institution: Newcastle Univesity - Newcastle University ePrints

repositories_institution: Newcastle Univesity - Newcastle University ePrints

repositories_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

title: Clinical outcomes in patients with atrial fibrillation and frailty: insights from the ENGAGE AF-TIMI 48 trial

ReferenceCitation: Vilain K, Li H, Kwong WJ, Antman EM, Ruff CT, Braunwald E, Cohen DJ, Giugliano RP, Magnuson EA; ENGAGE AF-TIMI 48 Trial Investigators. Cardiovascular- and Bleeding-Related Hospitalization Rates With Edoxaban Versus Warfarin in Patients With Atrial Fibrillation Based on Results of the ENGAGE AF-TIMI 48 Trial. Circ Cardiovasc Qual Outcomes. 2020 Nov;13(11):e006511. doi: 10.1161/CIRCOUTCOMES.120.006511. Epub 2020 Nov 5.

name: Saint Luke’s Mid America Heart Institute, Kansas City, MO (K.V., H.L., E.A.M.).

name: Daiichi Sankyo, Inc, Basking Ridge, NJ (W.J.K.).

name: TIMI Study Group, Brigham and Women’s Hospital, Boston, MA (E.M.A., C.T.R., E.B., R.P.G.)

name: University of Missouri–Kansas City School of Medicine (D.J.C., E.A.M.).

name: on behalf of the ENGAGE AF-TIMI 48 Trial Investigators

journal_name: Circulation: Cardiovascular Quality and Outcomes

title: Cardiovascular- and Bleeding-Related Hospitalization Rates With Edoxaban Versus Warfarin in Patients With Atrial Fibrillation Based on Results of the ENGAGE AF–TIMI 48 Trial

ReferenceCitation: Inciardi RM, Giugliano RP, Claggett B, Gupta DK, Chandra A, Ruff CT, Antman EM, Mercuri MF, Grosso MA, Braunwald E, Solomon SD; ENGAGE AF-TIMI 48 Investigators. Left atrial structure and function and the risk of death or heart failure in atrial fibrillation. Eur J Heart Fail. 2019 Dec;21(12):1571-1579. doi: 10.1002/ejhf.1606. Epub 2019 Nov 27.

name: Cardiovascular Division, Department of MedicineBrigham and Women's Hospital, Harvard Medical School Boston MA USA

name: Division of Cardiology, Department of MedicineUniversity Hospital of Verona Verona Italy

name: TIMI Study Group, Cardiovascular Division, Department of MedicineBrigham and Women's Hospital, Harvard Medical School Boston MA USA

name: Vanderbilt Translational and Clinical Cardiovascular Research Center, Division of Cardiovascular Medicine, Department of MedicineVanderbilt University Medical Center Nashville TN USA

name: Cardiovascular, Metabolic and Renal Disease Therapeutic Area, Global Clinical Development, Daiichi Sankyo Pharma Development Basking Ridge NJ USA

name: on behalf of the ENGAGE AF‐TIMI 48 Investigators

title: Left atrial structure and function and the risk of death or heart failure in atrial fibrillation

ReferenceCitation: Bergmark BA, Kamphuisen PW, Wiviott SD, Ruff CT, Antman EM, Nordio F, Kuder JF, Mercuri MF, Lanz HJ, Braunwald E, Giugliano RP. Comparison of Events Across Bleeding Scales in the ENGAGE AF-TIMI 48 Trial. Circulation. 2019 Nov 26;140(22):1792-1801. doi: 10.1161/CIRCULATIONAHA.119.041346. Epub 2019 Oct 10.

name: TIMI Study Group, Cardiovascular Division, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA (B.A.B., S.D.W., C.T.R., E.M.A., F.N., J.F.K., E.B., R.P.C.).

name: Department of Internal Medicine, Tergooi Hospital, Hilversum, the Netherlands (P.W.K.).

name: Daiichi Sankyo Pharma Development, Edison, NJ (M.F.M.).

name: Daiichi Sankyo Europe GmbH, Munich, Germany (H.J.L.).

title: Comparison of Events Across Bleeding Scales in the ENGAGE AF-TIMI 48 Trial

ReferenceCitation: Berg DD, Ruff CT, Jarolim P, Giugliano RP, Nordio F, Lanz HJ, Mercuri MF, Antman EM, Braunwald E, Morrow DA. Performance of the ABC Scores for Assessing the Risk of Stroke or Systemic Embolism and Bleeding in Patients With Atrial Fibrillation in ENGAGE AF-TIMI 48. Circulation. 2019 Feb 5;139(6):760-771. doi: 10.1161/CIRCULATIONAHA.118.038312.

name: TIMI Study Group, Cardiovascular Division, Department of Medicine (D.D.B., C.T.R., R.P.G., F.N., E.M.A., E.B., D.A.M.), Brigham and Women’s Hospital, Harvard Medical School, Boston, MA.

name: Department of Pathology (P.J.), Brigham and Women’s Hospital, Harvard Medical School, Boston, MA.

name: Daiichi Sankyo, Munich, Germany (H.J.L.).

name: Daiichi Sankyo, Basking Ridge, NJ (M.F.M.).

ReferenceCitation: Corbalán R, Nicolau JC, López-Sendon J, Garcia-Castillo A, Botero R, Sotomora G, Horna M, Ruff CT, Hamershock RA, Grip LT, Antman EM, Braunwald E, Giugliano RP. Edoxaban Versus Warfarin in Latin American Patients With Atrial Fibrillation: The ENGAGE AF-TIMI 48 Trial. J Am Coll Cardiol. 2018 Sep 25;72(13):1466-1475. doi: 10.1016/j.jacc.2018.07.037.

title: Edoxaban Versus Warfarin in Latin American Patients With Atrial Fibrillation

ReferenceCitation: Yin OQP, Antman EM, Braunwald E, Mercuri MF, Miller R, Morrow D, Ruff CT, Truitt K, Weitz JI, Giugliano RP. Linking Endogenous Factor Xa Activity, a Biologically Relevant Pharmacodynamic Marker, to Edoxaban Plasma Concentrations and Clinical Outcomes in the ENGAGE AF-TIMI 48 Trial. Circulation. 2018 Oct 30;138(18):1963-1973. doi: 10.1161/CIRCULATIONAHA.118.033933.

name: Daiichi-Sankyo Pharma Development, Basking Ridge, NJ (O.Q.P.Y., M.F.M., R.M., K.T.).

name: TIMI Study Group, Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, MA (E.M.A., E.B., D.M., C.T.R., R.P.G.).

name: McMaster University and Thrombosis and Atherosclerosis Research Institute, Hamilton, Ontario, Canada (J.I.W.).

ReferenceCitation: Aisenberg J, Chatterjee-Murphy P, Friedman Flack K, Weitz JI, Ruff CT, Nordio F, Mercuri MF, Choi Y, Antman EM, Braunwald E, Giugliano RP. Gastrointestinal Bleeding With Edoxaban Versus Warfarin: Results From the ENGAGE AF-TIMI 48 Trial (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis In Myocardial Infarction). Circ Cardiovasc Qual Outcomes. 2018 May;11(5):e003998. doi: 10.1161/CIRCOUTCOMES.117.003998.

name: Department of Medicine, Icahn School of Medicine, Mount Sinai Medical Center, New York, NY (J.A., P.C.-M.)

name: Department of Medicine, University of Pennsylvania, Philadelphia (K.F.F.)

name: McMaster University and Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (J.I.W.)

name: TIMI Study Group, Division of Cardiovascular Medicine and Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA (C.T.R., F.N., E.M.A., E.B., R.P.G.)

name: Daiichi Sankyo Pharma Development, Basking Ridge, NJ (M.F.M., Y.C.).

title: Gastrointestinal Bleeding With Edoxaban Versus Warfarin

ReferenceCitation: Wang K, Li H, Kwong WJ, Antman EM, Ruff CT, Giugliano RP, Cohen DJ, Magnuson EA; ENGAGE AF-TIMI 48 Trial Investigators. Impact of Spontaneous Extracranial Bleeding Events on Health State Utility in Patients with Atrial Fibrillation: Results from the ENGAGE AF-TIMI 48 Trial. J Am Heart Assoc. 2017 Aug 11;6(8). pii: e006703. doi: 10.1161/JAHA.117.006703.

name: Saint Luke's Mid America Heart Institute, Kansas City, MO

name: TIMI Study Group, Brigham and Women's Hospital, Boston, MA

name: University of Missouri—Kansas City School of Medicine, Kansas City, MO

name: the ENGAGE AF‐TIMI 48 Trial Investigators

title: Impact of Spontaneous Extracranial Bleeding Events on Health State Utility in Patients with Atrial Fibrillation: Results from the ENGAGE AF‐TIMI 48 Trial

ReferenceCitation: Eisen A, Ruff CT, Braunwald E, Hamershock RA, Lewis BS, Hassager C, Chao TF, Le Heuzey JY, Mercuri M, Rutman H, Antman EM, Giugliano RP. Digoxin Use and Subsequent Clinical Outcomes in Patients With Atrial Fibrillation With or Without Heart Failure in the ENGAGE AF-TIMI 48 Trial. J Am Heart Assoc. 2017 Jun 30;6(7). pii: e006035. doi: 10.1161/JAHA.117.006035.

name: TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA

name: Department of Medicine, Harvard Medical School, Boston, MA

name: Lady Davis Carmel Medical Center, Haifa, Israel

name: Taipei Veterans General Hospital, Taipei, Taiwan

name: Georges Pompidou Hospital, René Descartes University, Paris, France

repository_institution: University of Copenhagen - Research at the University of Copenhagen

repositories_institution: University of Copenhagen - Research at the University of Copenhagen

title: Digoxin Use and Subsequent Clinical Outcomes in Patients With Atrial Fibrillation With or Without Heart Failure in the ENGAGE AF‐TIMI 48 Trial

ReferenceCitation: De Caterina R, Renda G, Carnicelli AP, Nordio F, Trevisan M, Mercuri MF, Ruff CT, Antman EM, Braunwald E, Giugliano RP. Valvular Heart Disease Patients on Edoxaban or Warfarin in the ENGAGE AF-TIMI 48 Trial. J Am Coll Cardiol. 2017 Mar 21;69(11):1372-1382. doi: 10.1016/j.jacc.2016.12.031. Erratum in: J Am Coll Cardiol. 2019 Feb 12;73(5):627.

title: Valvular Heart Disease Patients on Edoxaban or Warfarin in the ENGAGE AF-TIMI 48 Trial

ReferenceCitation: Link MS, Giugliano RP, Ruff CT, Scirica BM, Huikuri H, Oto A, Crompton AE, Murphy SA, Lanz H, Mercuri MF, Antman EM, Braunwald E; ENGAGE AF-TIMI 48 Investigators. Stroke and Mortality Risk in Patients With Various Patterns of Atrial Fibrillation: Results From the ENGAGE AF-TIMI 48 Trial (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48). Circ Arrhythm Electrophysiol. 2017 Jan;10(1). pii: e004267. doi: 10.1161/CIRCEP.116.004267.

name: From the Department of Medicine, UTSouthwestern Medical Center, Dallas, TX (M.S.L.); TIMI Study Group, Brigham and Women’s Hospital, Boston, MA (R.P.G., C.T.R., B.M.S., A.E.C., S.A.M., E.M.A., E.B.); Department of Medicine, University of Oulu, Finland (H.H.); Oulu University Hospital, Finland (H.H.); Heart and Health Foundation of Turkey, Ankara (A.O.); Daiichi-Sankyo Pharma Development, Munich, Germany (H.L.); and Daiichi-Sankyo Pharma Development, Edison, NJ (M.F.M.).

journal_name: Circulation: Arrhythmia and Electrophysiology

title: Stroke and Mortality Risk in Patients With Various Patterns of Atrial Fibrillation

ReferenceCitation: Ruff CT, Giugliano RP, Braunwald E, Murphy SA, Brown K, Jarolim P, Mercuri M, Antman EM, Morrow DA. Cardiovascular Biomarker Score and Clinical Outcomes in Patients With Atrial Fibrillation: A Subanalysis of the ENGAGE AF-TIMI 48 Randomized Clinical Trial. JAMA Cardiol. 2016 Dec 1;1(9):999-1006. doi: 10.1001/jamacardio.2016.3311.

name: TIMI Study Group 2Cardiovascular Medicine Division, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts

name: Daiichi Sankyo Pharma Development, Edison, New Jersey

name: Department of Pathology and Laboratory Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts

title: Cardiovascular Biomarker Score and Clinical Outcomes in Patients With Atrial Fibrillation

ReferenceCitation: Steffel J, Giugliano RP, Braunwald E, Murphy SA, Mercuri M, Choi Y, Aylward P, White H, Zamorano JL, Antman EM, Ruff CT. Edoxaban Versus Warfarin in Atrial Fibrillation Patients at Risk of Falling: ENGAGE AF-TIMI 48 Analysis. J Am Coll Cardiol. 2016 Sep 13;68(11):1169-1178. doi: 10.1016/j.jacc.2016.06.034. Erratum in: J Am Coll Cardiol. 2017 Jul 25;70(4):512-513.

title: Edoxaban Versus Warfarin in Atrial Fibrillation Patients at Risk of Falling

ReferenceCitation: Eisen A, Ruff CT, Braunwald E, Nordio F, Corbalán R, Dalby A, Dorobantu M, Mercuri M, Lanz H, Rutman H, Wiviott SD, Antman EM, Giugliano RP. Sudden Cardiac Death in Patients With Atrial Fibrillation: Insights From the ENGAGE AF-TIMI 48 Trial. J Am Heart Assoc. 2016 Jul 8;5(7). pii: e003735. doi: 10.1161/JAHA.116.003735.

name: Hospital Clinico Pontificia Universidad Catolica de Chile, Santiago, Chile

name: Milpark Hospital, Johannesburg, South Africa

name: Emergency Clinical Hospital, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania

title: Sudden Cardiac Death in Patients With Atrial Fibrillation: Insights From the ENGAGE AF‐TIMI 48 Trial

ReferenceCitation: Rost NS, Giugliano RP, Ruff CT, Murphy SA, Crompton AE, Norden AD, Silverman S, Singhal AB, Nicolau JC, SomaRaju B, Mercuri MF, Antman EM, Braunwald E; ENGAGE AF-TIMI 48 Investigators. Outcomes With Edoxaban Versus Warfarin in Patients With Previous Cerebrovascular Events: Findings From ENGAGE AF-TIMI 48 (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48). Stroke. 2016 Aug;47(8):2075-82. doi: 10.1161/STROKEAHA.116.013540. Epub 2016 Jul 7.

name: From the Massachusetts General Hospital, Boston (N.S.R., S.S., A.B.S.); TIMI Study Group, Cardiovascular Medicine, Brigham and Women’s Hospital, Boston MA (R.P.G., C.T.R., S.A.M., A.E.C., A.D.N., E.M.A., E.B.); Heart Institute (InCor), University of São Paulo Medical School, Brazil (J.C.N.); CARE Musheerabad, Hyderabad, India (B.S.); and Daiichi-Sankyo Pharma Development, Edison, NJ (M.F.M.).

title: Outcomes With Edoxaban Versus Warfarin in Patients With Previous Cerebrovascular Events

ReferenceCitation: Bohula EA, Giugliano RP, Ruff CT, Kuder JF, Murphy SA, Antman EM, Braunwald E. Impact of Renal Function on Outcomes With Edoxaban in the ENGAGE AF-TIMI 48 Trial. Circulation. 2016 Jul 5;134(1):24-36. doi: 10.1161/CIRCULATIONAHA.116.022361.

name: From the TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA.

title: Impact of Renal Function on Outcomes With Edoxaban in the ENGAGE AF-TIMI 48 Trial

ReferenceCitation: Kato ET, Giugliano RP, Ruff CT, Koretsune Y, Yamashita T, Kiss RG, Nordio F, Murphy SA, Kimura T, Jin J, Lanz H, Mercuri M, Braunwald E, Antman EM. Efficacy and Safety of Edoxaban in Elderly Patients With Atrial Fibrillation in the ENGAGE AF-TIMI 48 Trial. J Am Heart Assoc. 2016 May 20;5(5). pii: e003432. doi: 10.1161/JAHA.116.003432.

name: TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA

name: Tokai University Hospital, Isehara, Japan

name: The Cardiovascular Institute, Tokyo, Japan

title: Efficacy and Safety of Edoxaban in Elderly Patients With Atrial Fibrillation in the ENGAGE AF–TIMI 48 Trial

ReferenceCitation: Xu H, Ruff CT, Giugliano RP, Murphy SA, Nordio F, Patel I, Shi M, Mercuri M, Antman EM, Braunwald E. Concomitant Use of Single Antiplatelet Therapy With Edoxaban or Warfarin in Patients With Atrial Fibrillation: Analysis From the ENGAGE AF-TIMI48 Trial. J Am Heart Assoc. 2016 Feb 23;5(2). pii: e002587. doi: 10.1161/JAHA.115.002587.

name: TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA

name: Daiichi Sankyo Pharma Development, Edison, NJ

title: Concomitant Use of Single Antiplatelet Therapy With Edoxaban or Warfarin in Patients With Atrial Fibrillation: Analysis From the ENGAGE AF‐TIMI48 Trial

ReferenceCitation: Ruff CT, Giugliano RP, Braunwald E, Morrow DA, Murphy SA, Kuder JF, Deenadayalu N, Jarolim P, Betcher J, Shi M, Brown K, Patel I, Mercuri M, Antman EM. Association between edoxaban dose, concentration, anti-Factor Xa activity, and outcomes: an analysis of data from the randomised, double-blind ENGAGE AF-TIMI 48 trial. Lancet. 2015 Jun 6;385(9984):2288-95. doi: 10.1016/S0140-6736(14)61943-7. Epub 2015 Mar 11.

ReferenceCitation: Mega JL, Walker JR, Ruff CT, Vandell AG, Nordio F, Deenadayalu N, Murphy SA, Lee J, Mercuri MF, Giugliano RP, Antman EM, Braunwald E, Sabatine MS. Genetics and the clinical response to warfarin and edoxaban: findings from the randomised, double-blind ENGAGE AF-TIMI 48 trial. Lancet. 2015 Jun 6;385(9984):2280-7. doi: 10.1016/S0140-6736(14)61994-2. Epub 2015 Mar 11.

ReferenceCitation: Ruff CT, Giugliano RP, Braunwald E, Mercuri M, Curt V, Betcher J, Grip L, Cange AL, Crompton AE, Murphy SA, Deenadayalu N, Antman EM. Transition of patients from blinded study drug to open-label anticoagulation: the ENGAGE AF-TIMI 48 trial. J Am Coll Cardiol. 2014 Aug 12;64(6):576-84. doi: 10.1016/j.jacc.2014.05.028.

title: Transition of Patients From Blinded Study Drug to Open-Label Anticoagulation

ReferenceCitation: Giugliano RP, Ruff CT, Rost NS, Silverman S, Wiviott SD, Lowe C, Deenadayalu N, Murphy SA, Grip LT, Betcher JM, Duggal A, Dave J, Shi M, Mercuri M, Antman EM, Braunwald E; ENGAGE AF-TIMI 48 Investigators. Cerebrovascular events in 21 105 patients with atrial fibrillation randomized to edoxaban versus warfarin: Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48. Stroke. 2014 Aug;45(8):2372-8. doi: 10.1161/STROKEAHA.114.006025. Epub 2014 Jun 19.

name: From the Division of Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, MA (R.P.G., C.T.R., S.D.W., C.L., N.D., S.A.M., L.T.G., E.M.A., E.B.); Department of Neurology, Massachusetts General Hospital, Boston (N.S.R., S.S.); Biostatistics, Quintiles, Inc, Durham, NC (J.M.B.); and Daiichi Sankyo, Inc, Pharma Development, Edison, NJ (A.D., J.D., M.S., M.M.).

title: Cerebrovascular Events in 21 105 Patients With Atrial Fibrillation Randomized to Edoxaban Versus Warfarin

ReferenceCitation: Gupta DK, Shah AM, Giugliano RP, Ruff CT, Antman EM, Grip LT, Deenadayalu N, Hoffman E, Patel I, Shi M, Mercuri M, Mitrovic V, Braunwald E, Solomon SD; Effective aNticoaGulation with factor xA next GEneration in AF-Thrombolysis In Myocardial Infarction 48 Echocardiographic Study Investigators. Left atrial structure and function in atrial fibrillation: ENGAGE AF-TIMI 48. Eur Heart J. 2014 Jun 7;35(22):1457-65. doi: 10.1093/eurheartj/eht500. Epub 2013 Dec 2.

name: Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 75 Francis St, Boston, MA 02115, USA

name: TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA

name: Daiichi-Sankyo Pharma Development, Edison, NJ, USA

name: Kerckhoff Clinic Nauheim, Bad Nauheim, Germany

name: for the Effective aNticoaGulation with factor xA next GEneration in AF-Thrombolysis In Myocardial Infarction 48 (ENGAGE AF-TIMI 48) Echocardiographic Study Investigators

title: Left atrial structure and function in atrial fibrillation: ENGAGE AF-TIMI 48

ReferenceCitation: Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Špinar J, Ruzyllo W, Ruda M, Koretsune Y, Betcher J, Shi M, Grip LT, Patel SP, Patel I, Hanyok JJ, Mercuri M, Antman EM; ENGAGE AF-TIMI 48 Investigators. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013 Nov 28;369(22):2093-104. doi: 10.1056/NEJMoa1310907. Epub 2013 Nov 19.

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

title: Edoxaban versus Warfarin in Patients with Atrial Fibrillation

ReferenceCitation: Salazar DE, Mendell J, Kastrissios H, Green M, Carrothers TJ, Song S, Patel I, Bocanegra TS, Antman EM, Giugliano RP, Kunitada S, Dornseif B, Shi M, Tachibana M, Zhou S, Rohatagi S. Modelling and simulation of edoxaban exposure and response relationships in patients with atrial fibrillation. Thromb Haemost. 2012 May;107(5):925-36. doi: 10.1160/TH11-08-0566. Epub 2012 Mar 8.

title: Modelling and simulation of edoxaban exposure and response relationships in patients with atrial fibrillation

ReferenceCitation: Ruff CT, Giugliano RP, Antman EM, Crugnale SE, Bocanegra T, Mercuri M, Hanyok J, Patel I, Shi M, Salazar D, McCabe CH, Braunwald E. Evaluation of the novel factor Xa inhibitor edoxaban compared with warfarin in patients with atrial fibrillation: design and rationale for the Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation-Thrombolysis In Myocardial Infarction study 48 (ENGAGE AF-TIMI 48). Am Heart J. 2010 Oct;160(4):635-41. doi: 10.1016/j.ahj.2010.06.042.

title: Evaluation of the novel factor Xa inhibitor edoxaban compared with warfarin in patients with atrial fibrillation: Design and rationale for the Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation–Thrombolysis In Myocardial Infarction study 48 (ENGAGE AF–TIMI 48)

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

location_country:
Peru
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Greece
Romania
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Australia
Russian Federation
Denmark
Taiwan
Ukraine
India
Croatia
France
Japan
Poland
Slovakia
Norway
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Canada
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Turkey
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title: Optimal Antitachycardia Therapy in ICD Patients Without Pacing Indications

acronym: OPTION

summary: This study evaluates the impact of a new pacing mode avoiding unnecessary ventricular stimulation in combination with advanced dual chamber detection with slow VT management on the clinical outcome for hospitalization and mortality and inadequate therapy in medically stable, ICD-indicated patients with impaired left ventricular function (LVEF ≤ 40%) who do not have pacing indications and no indication for Cardiac Resynchronization Therapy (CRT). It compares a new pacing mode avoiding ventricular stimulation when not needed combined with dual chamber detection with a pure ventricular back up pacing and single chamber detection criteria with pure ventricular back up pacing. Therapies are compared in a prospective, randomized, single-blinded, parallel trial with a 24-month randomized treatment period. Randomization follows a 1:1 ratio. ICD therapy is enabled for all patients throughout the study. All patients receive optimal drug therapy for arrhythmia and heart failure treatment.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Kolb C, Tzeis S, Sturmer M, Babuty D, Schwab JO, Mantovani G, Janko S, Aimé E, Ocklenburg R, Sick P. Rationale and design of the OPTION study: optimal antitachycardia therapy in ICD patients without pacing indications. Pacing Clin Electrophysiol. 2010 Sep;33(9):1141-8. doi: 10.1111/j.1540-8159.2010.02790.x.

ReferenceType: result

ReferenceCitation: Kolb C, Sturmer M, Sick P, Reif S, Davy JM, Molon G, Schwab JO, Mantovani G, Dan D, Lennerz C, Borri-Brunetto A, Babuty D. Reduced risk for inappropriate implantable cardioverter-defibrillator shocks with dual-chamber therapy compared with single-chamber therapy: results of the randomized OPTION study. JACC Heart Fail. 2014 Dec;2(6):611-9. doi: 10.1016/j.jchf.2014.05.015. Epub 2014 Oct 1.

family: Kolb

full_name: Christof Kolb

given: Christof

sequence: first

family: Sturmer

full_name: Marcio Sturmer

given: Marcio

sequence: additional

family: Sick

full_name: Peter Sick

given: Peter

family: Reif

full_name: Sebastian Reif

given: Sebastian

family: Davy

full_name: Jean Marc Davy

given: Jean Marc

family: Molon

full_name: Giulio Molon

given: Giulio

family: Schwab

full_name: Jörg Otto Schwab

given: Jörg Otto

family: Mantovani

full_name: Giuseppe Mantovani

given: Giuseppe

family: Dan

full_name: Dan Dan

given: Dan

family: Lennerz

full_name: Carsten Lennerz

given: Carsten

family: Borri-Brunetto

full_name: Alberto Borri-Brunetto

given: Alberto

family: Babuty

full_name: Dominique Babuty

given: Dominique

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: JACC: Heart Failure

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Reduced Risk for Inappropriate Implantable Cardioverter-Defibrillator Shocks With Dual-Chamber Therapy Compared With Single-Chamber Therapy

lead_sponsor: LivaNova

location_country:
Italy
United States
Netherlands
Germany
France
Belgium
Portugal
Canada
United Kingdom

location_facility: Universitatsklinikum Schleswig-Holstein Campus Lübeck

location_facility: Heart Center Virga Jesse Ziekenhuis - Hasselt

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Completed


title: BRIEF: Bendamustine and Rituximab In Elderly Follicular: A Multicentric Phase II Study Evaluating the Benefit of a Short Induction Treatment by Bendamustine and Rituximab Followed by Maintenance Therapy With Rituximab In Elderly (≥ 60 Years Old) Patients With Untreated Follicular Lymphoma Patients, With an Intermediate or High FLIPI Score

acronym: BRIEF

summary:
The objective of this study is to evaluate the complete response rate after a short induction treatment with rituximab (375mg/m2)and bendamustine (90mg/m2)in In Elderly (≥ 60 years old) patients with untreated Follicular lymphoma, with an intermediate or high FLIPI score and without high tumor burden.

This short induction is followed by a rituximab (375mg/m2)maintenance/ Induction schedule:Rituximab+Bendamustine on Day 1, Bendamustine on Day 2, Rituximab on Day 8, Rituximab on Day 15, rituximab on day 22, Bendamustine on Day 29, Bendamustine on Day 30 Maintenance schedule: 12 infusions of rituximab, each 8 weeks

study_start_date_type: Actual

status: Terminated

ReferenceType: derived

ReferenceCitation: Gyan E, Sonet A, Brice P, Anglaret B, Laribi K, Fruchart C, Tilly H, Araujo C, Soubeyran P, Gonzalez H, Morineau N, Nicolas-Virelizier E, Ghesquières H, Salles B, Bouabdallah R, Orfeuvre H, Fahri J, Couturier O, Xerri L, Feugier P; Lymphoma Study Association (LYSA). Bendamustine and rituximab in elderly patients with low-tumour burden follicular lymphoma. Results of the LYSA phase II BRIEF study. Br J Haematol. 2018 Oct;183(1):76-86. doi: 10.1111/bjh.15513. Epub 2018 Aug 16.

name: Department of Haematology and Cell Therapy; University Hospital; Tours France

name: Clinical Investigation Centre; INSERM U1415, University Hospital; Tours France

family: Gyan

full_name: Emmanuel Gyan

given: Emmanuel

name: Department of Haematology; Mont-Godinne University; Université Catholique de Louvain; CHU UCL Namur; Yvoir Belgium

family: Sonet

full_name: Anne Sonet

given: Anne

name: Department of Haematology; Saint-Louis Hospital; AP-HP; Paris France

family: Brice

full_name: Pauline Brice

given: Pauline

name: Department of Haematology; Valence Hospital; Valence France

family: Anglaret

full_name: Bruno Anglaret

given: Bruno

name: Department of Haematology; Le Mans Hospital; Le Mans France

family: Laribi

full_name: Kamel Laribi

given: Kamel

name: Department of Haematology; Centre Francois Baclesse; Caen France

family: Fruchart

full_name: Christophe Fruchart

given: Christophe

name: Department of Haematology; Centre Henri Becquerel; Rouen France

family: Tilly

full_name: Hervé Tilly

given: Hervé

name: Department of Haematology; Bayonne Hospital; Bayonne France

family: Araujo

full_name: Carla Araujo

given: Carla

name: Department of Haematology; Institut Bergonié; Bordeaux France

family: Soubeyran

full_name: Pierre Soubeyran

given: Pierre

name: Department of Haematology; René Dubos Hospital; Pontoise France

family: Gonzalez

full_name: Hugo Gonzalez

given: Hugo

name: Department of Haematology; Catherine de Sienne Centre; Nantes France

family: Morineau

full_name: Nadine Morineau

given: Nadine

name: Department of Haematology; Francois Magendie Centre; Pessac France

family: Nicolas-Virelizier

full_name: Emmanuelle Nicolas-Virelizier

given: Emmanuelle

name: Department of Haematology; Léon Bérard Centre; Lyon France

family: Ghesquières

full_name: Hervé Ghesquières

name: Department of Haematology; Châlon Hospital; Châlon-sur-Saône France

family: Salles

full_name: Bruno Salles

name: Department of Haematology; Paoli-Calmettes Institute; Marseille France

family: Bouabdallah

full_name: Réda Bouabdallah

given: Réda

name: Department of Haematology; Bourg-en-Bresse Hospital; Bourg-en-Bresse France

family: Orfeuvre

full_name: Hubert Orfeuvre

given: Hubert

name: Department of Haematology; Angers University Hospital; Angers France

family: Fahri

full_name: Jonathan Fahri

given: Jonathan

name: Lysa Pathology Department; Mondor University Hospital; Créteil France

family: Couturier

full_name: Olivier Couturier

given: Olivier

name: Lysa Imaging Department; Mondor University Hospital; Créteil France

family: Xerri

full_name: Luc Xerri

given: Luc

name: Department of Haematology; University Hospital, and INSERM U954; Nancy France

family: Feugier

full_name: Pierre Feugier

journal_name: British Journal of Haematology

evidence: open (via free article)

license_normalized: no license

publisher: Wiley

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: CHU de Poitiers - Hôpital de la Milétrie

location_facility: Centre Hospitalier de la Région d'Annecy

location_facility: Centre Hospitalier de Wallonie Picarde - CHwapi

location_facility: AZ Groeninge - Campus Maria's Voorzienigheid

location_facility: Université Libre de Bruxelles - Hôpital Erasme

location_facility: CHU LIMOGES - Hôpital Universitaire Dupuytren

location_facility: Université Catholique de Louvain Saint Luc


title: FORTIS-M: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Oral Talactoferrin in Addition to Best Supportive Care in Patients With Non-small Cell Lung Cancer Who Have Failed Two or More Prior Treatment Regimens

acronym: FORTIS-M

summary: The purpose of this study is to determine whether talactoferrin can improve overall survival in patients with non-small cell lung cancer (NSCLC) who have been previously treated with two or more regimens.

lead_sponsor: Agennix

location_country:
Malaysia
Greece
Romania
Australia
Russian Federation
Czech Republic
Taiwan
India
France
Poland
Canada
Korea, Republic of
Philippines
Bulgaria
Singapore
Hungary
United States
Germany
United Kingdom
Italy
Spain
Turkey
Latvia

location_facility: Azienda Ospedaliera Istituti Ospitalieri di Cremona

location_facility: Riga Eastern Clinical University Hospital

location_facility: Spitalul Judetean de Urgenta "Sf. Ioan cel Nou" Suceava

location_facility: NCI, CCR, The Waren Grant Magnuson Clinical Center

location_facility: SEIHPE "Saint Petersburg SMU RosZdrav n.a. I.I.Pavlov"

location_facility: Centrum Onkologii-Instytut im. M. Sklodowskiej Curie

location_facility: The Catholic University of Korea St. Vincent's Hospital

location_facility: Specjalistyczny Szpital im. Prof. A. Sokolowskiego

location_facility: CRO Centro di Riferimento Oncologico di Aviano

location_facility: Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

location_facility: Mahaveer Cancer Hospital and Research Centre

location_facility: Gemeinschaftspraxis fuer Haematologie Onkologie

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I

location_facility: Cancer Care Specialists of Central Illinois

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: University Hospital of North Staffordshire

location_facility: Indo-American Cancer Institute and Research Center

location_facility: Gerald Bronfman Centre for Clinical Research in Oncology

location_facility: Klinikum rechts der Isar der TU Muenchen

location_facility: General Hospital of Chania 'Ag. Georgios'

location_facility: Akademickie Centrum Kliniczne - Szpital AM w Gdansku

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

location_facility: General Hospital of Thessaloniki "G. Papanikolaou"

location_facility: P.D. Hinduja Nat. Hospital & Med. Research Centre

location_facility: Nilai Cancer Institute (NCI Cancer Hospital)

location_facility: Staedt. Krankenhaus Martha-Maria Halle-Doelau gGmbH

location_facility: Chonnam National University Hwasun Hospital

location_facility: Kaushalya Medical Foundation Trust Hospital

location_facility: Dr. Anna Levcenko GP and Internist Practice

location_facility: University Hospital of Coventry and Warwickshire

location_facility: Cancer Care & Hematology Specialists of Chicagoland

location_facility: Szabolcs-Szatmar Bereg Megyei Josa Andras Oktato Korhaz

location_facility: University Hospital of South Manchester NHS Foundation Trust Wythenshawe Hospital

location_facility: Deenanath Mangeshkar Hospital and Research Center

location_facility: Istituto per la Ricerca e la Cura del Cancro

location_facility: Washington University School of Medicine

location_facility: Orszagos Koranyi TBC es Pulmonologiai Intezet

location_facility: Chang-Gung Memorial Hospital, Linkou Branch

location_facility: Seoul National University Bundang Hospital

location_facility: Institut Onkologie a Rehabilitace Na Plesi

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: P. Stradina Clinical University Hospital

location_facility: NZOZ Olsztynski Osr. Onkologiczny "Kopernik" Sp.z o.o

location_facility: Oncology Dispensary #2 of Krasnodar Region

location_facility: Praxis fuer interdisziplinaere Onkologie

location_facility: CCH #2 n.a. N. A. Semashko of LLC "Russian Railways"

location_facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca

location_facility: John Hopkins Singapore International Medical Centre

location_facility: Miskolc Megyei Jogu Varos Onkormanyzat Miskolci Egeszsegugyi

location_facility: Spitalul Judetean de Urgenta "Dr. Constantin Opris"

intervention_type: Drug


title: Prospective, Single-Arm, Multi-Centre, Observational Registry to Further Validate Safety and Efficacy of the Nobori DES in Real-World Patients

acronym: e-NOBORI

summary:
Title Prospective, single-arm, multi-centre, observational registry to further validate safety and efficacy of the Nobori® DES in real-world patients.

Objective Primary objective The primary objective of e-NOBORI registry is to further validate the safety and efficacy of Nobori® DES system in unselected patients representing everyday clinical practice.

Primary Endpoint: Freedom from Target Lesion Failure (TLF) defined as a composite of cardiac death, target vessel related myocardial infarction (MI) and clinically driven target lesion revascularization (TLR) at 1 year

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Sigwart U, Puel J, Mirkovitch V, Joffre F, Kappenberger L. Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty. N Engl J Med. 1987 Mar 19;316(12):701-6.

ReferenceCitation: Detre KM, Holmes DR Jr, Holubkov R, Cowley MJ, Bourassa MG, Faxon DP, Dorros GR, Bentivoglio LG, Kent KM, Myler RK. Incidence and consequences of periprocedural occlusion. The 1985-1986 National Heart, Lung, and Blood Institute Percutaneous Transluminal Coronary Angioplasty Registry. Circulation. 1990 Sep;82(3):739-50.

ReferenceCitation: Holmes DR Jr, Holubkov R, Vlietstra RE, Kelsey SF, Reeder GS, Dorros G, Williams DO, Cowley MJ, Faxon DP, Kent KM, et al. Comparison of complications during percutaneous transluminal coronary angioplasty from 1977 to 1981 and from 1985 to 1986: the National Heart, Lung, and Blood Institute Percutaneous Transluminal Coronary Angioplasty Registry. J Am Coll Cardiol. 1988 Nov;12(5):1149-55.

ReferenceCitation: Fischman DL, Leon MB, Baim DS, Schatz RA, Savage MP, Penn I, Detre K, Veltri L, Ricci D, Nobuyoshi M, et al. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators. N Engl J Med. 1994 Aug 25;331(8):496-501.

ReferenceCitation: Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V, Materne P, et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. N Engl J Med. 1994 Aug 25;331(8):489-95.

ReferenceCitation: Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnàr F, Falotico R; RAVEL Study Group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002 Jun 6;346(23):1773-80.

ReferenceCitation: Stettler C, Wandel S, Allemann S, Kastrati A, Morice MC, Schömig A, Pfisterer ME, Stone GW, Leon MB, de Lezo JS, Goy JJ, Park SJ, Sabaté M, Suttorp MJ, Kelbaek H, Spaulding C, Menichelli M, Vermeersch P, Dirksen MT, Cervinka P, Petronio AS, Nordmann AJ, Diem P, Meier B, Zwahlen M, Reichenbach S, Trelle S, Windecker S, Jüni P. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet. 2007 Sep 15;370(9591):937-48. Review.

ReferenceCitation: Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RE; SIRIUS Investigators. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003 Oct 2;349(14):1315-23.

ReferenceCitation: Holmes DR Jr, Leon MB, Moses JW, Popma JJ, Cutlip D, Fitzgerald PJ, Brown C, Fischell T, Wong SC, Midei M, Snead D, Kuntz RE. Analysis of 1-year clinical outcomes in the SIRIUS trial: a randomized trial of a sirolimus-eluting stent versus a standard stent in patients at high risk for coronary restenosis. Circulation. 2004 Feb 10;109(5):634-40.

ReferenceCitation: Grube E, Silber S, Hauptmann KE, Mueller R, Buellesfeld L, Gerckens U, Russell ME. TAXUS I: six- and twelve-month results from a randomized, double-blind trial on a slow-release paclitaxel-eluting stent for de novo coronary lesions. Circulation. 2003 Jan 7;107(1):38-42.

ReferenceCitation: Chevalier B, Serruys PW, Silber S, Garcia E, Suryapranata H, Hauptmann K, Wijns W, Schuler G, Fath-Ordoubadi F, Worthley S, Thuesen L, Meredith I, Bressers M, Nagai H, Paunovic D. Randomised comparison of Nobori, biolimus A9-eluting coronary stent with a Taxus(R), paclitaxel-eluting coronary stent in patients with stenosis in native coronary arteries: the Nobori 1 trial. EuroIntervention. 2007 Feb;2(4):426-34.

ReferenceCitation: Ostojic M, Sagic D, Beleslin B, Jung R, Perisic Z, Jagic N, Nedeljkovic M, Mangovski L, Milosavljevic B, Stojkovic S, Orlic D, Antonic Z, Miloradovic V, Topic D, Paunovic D. First clinical comparison of Nobori -Biolimus A9 eluting stents with Cypher- Sirolimus eluting stents: Nobori Core nine months angiographic and one year clinical outcomes. EuroIntervention. 2008 Mar;3(5):574-9.

ReferenceCitation: Iakovou I, Schmidt T, Bonizzoni E, Ge L, Sangiorgi GM, Stankovic G, Airoldi F, Chieffo A, Montorfano M, Carlino M, Michev I, Corvaja N, Briguori C, Gerckens U, Grube E, Colombo A. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA. 2005 May 4;293(17):2126-30.

ReferenceCitation: Chevalier B, Silber S, Park SJ, Garcia E, Schuler G, Suryapranata H, Koolen J, Hauptmann KE, Wijns W, Morice MC, Carrie D, van Es GA, Nagai H, Detiege D, Paunovic D, Serruys PW; NOBORI 1 Clinical Investigators. Randomized comparison of the Nobori Biolimus A9-eluting coronary stent with the Taxus Liberté paclitaxel-eluting coronary stent in patients with stenosis in native coronary arteries: the NOBORI 1 trial--Phase 2. Circ Cardiovasc Interv. 2009 Jun;2(3):188-95. doi: 10.1161/CIRCINTERVENTIONS.108.823443. Epub 2009 May 8.

ReferenceCitation: Jain AK, Meredith IT, Lotan C, Rothman MT, Pateraki S; E-Five Investigators. Real-world safety and efficacy of the endeavor zotarolimus-eluting stent: early data from the E-Five Registry. Am J Cardiol. 2007 Oct 22;100(8B):77M-83M.

ReferenceCitation: Urban P, Gershlick AH, Guagliumi G, Guyon P, Lotan C, Schofer J, Seth A, Sousa JE, Wijns W, Berge C, Deme M, Stoll HP; e-Cypher Investigators. Safety of coronary sirolimus-eluting stents in daily clinical practice: one-year follow-up of the e-Cypher registry. Circulation. 2006 Mar 21;113(11):1434-41. Epub 2006 Mar 13.

ReferenceCitation: Stone GW. SPIRIT IV A Prospective, Randomized Trial Comparing an Everolimus Eluting Stent and a Paclitaxel Eluting Stent in Patients With Coronary Artery Disease One Year Clinical Results. 2009.

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ReferenceCitation: Turco MA, Ormiston JA, Popma JJ, Mandinov L, O'Shaughnessy CD, Mann T, McGarry TF, Wu CJ, Chan C, Webster MW, Hall JJ, Mishkel GJ, Cannon LA, Baim DS, Koglin J. Polymer-based, paclitaxel-eluting TAXUS Liberté stent in de novo lesions: the pivotal TAXUS ATLAS trial. J Am Coll Cardiol. 2007 Apr 24;49(16):1676-83. Epub 2007 Apr 6.

ReferenceCitation: Rodriguez-Granillo GA, Valgimigli M, Garcia-Garcia HM, Ong AT, Aoki J, van Mieghem CA, Tsuchida K, Sianos G, McFadden E, van der Giessen WJ, van Domburg R, de Feyter P, Serruys PW. One-year clinical outcome after coronary stenting of very small vessels using 2.25 mm sirolimus- and paclitaxel-eluting stents: a comparison between the RESEARCH and T-SEARCH registries. J Invasive Cardiol. 2005 Aug;17(8):409-12.

ReferenceCitation: Ong AT, van Domburg RT, Aoki J, Sonnenschein K, Lemos PA, Serruys PW. Sirolimus-eluting stents remain superior to bare-metal stents at two years: medium-term results from the Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital (RESEARCH) registry. J Am Coll Cardiol. 2006 Apr 4;47(7):1356-60. Epub 2006 Mar 20.

ReferenceCitation: Galløe AM, Thuesen L, Kelbaek H, Thayssen P, Rasmussen K, Hansen PR, Bligaard N, Saunamäki K, Junker A, Aarøe J, Abildgaard U, Ravkilde J, Engstrøm T, Jensen JS, Andersen HR, Bøtker HE, Galatius S, Kristensen SD, Madsen JK, Krusell LR, Abildstrøm SZ, Stephansen GB, Lassen JF; SORT OUT II Investigators. Comparison of paclitaxel- and sirolimus-eluting stents in everyday clinical practice: the SORT OUT II randomized trial. JAMA. 2008 Jan 30;299(4):409-16. doi: 10.1001/jama.299.4.409.

ReferenceCitation: Kedhi E, Joesoef KS, McFadden E, Wassing J, van Mieghem C, Goedhart D, Smits PC. Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial. Lancet. 2010 Jan 16;375(9710):201-9. doi: 10.1016/S0140-6736(09)62127-9. Epub 2010 Jan 7.

ReferenceCitation: Novack V, Cutlip D, Kleiman N, Pencina M, Mauri L, Yen CH, Berger P, Goldberg S, Kellett M, Waksman R, Hong M, Raizner AE, Cohen DJ. In-hospital and 1-year outcomes among unselected percutaneous coronary intervention patients treated with either sirolimus- or paclitaxel-eluting stents: results from the EVENT (Evaluation of Drug Eluting Stents and Ischemic Events) registry. JACC Cardiovasc Interv. 2009 Aug;2(8):767-75. doi: 10.1016/j.jcin.2009.05.016.

ReferenceCitation: Windecker S, Serruys PW, Wandel S, Buszman P, Trznadel S, Linke A, Lenk K, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, Davies S, van Geuns RJ, Eerdmans P, van Es GA, Meier B, Jüni P. Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial. Lancet. 2008 Sep 27;372(9644):1163-73. doi: 10.1016/S0140-6736(08)61244-1. Epub 2008 Aug 31.

family: Windecker

full_name: Stephan Windecker

given: Stephan

family: Serruys

full_name: Patrick W Serruys

given: Patrick W

family: Wandel

full_name: Simon Wandel

given: Simon

family: Buszman

full_name: Pawel Buszman

given: Pawel

family: Trznadel

full_name: Stanislaw Trznadel

given: Stanislaw

family: Linke

full_name: Axel Linke

given: Axel

family: Lenk

full_name: Karsten Lenk

given: Karsten

family: Ischinger

full_name: Thomas Ischinger

given: Thomas

family: Klauss

full_name: Volker Klauss

given: Volker

family: Eberli

full_name: Franz Eberli

given: Franz

family: Corti

full_name: Roberto Corti

given: Roberto

family: Wijns

full_name: William Wijns

given: William

family: Morice

full_name: Marie-Claude Morice

given: Marie-Claude

family: di Mario

full_name: Carlo di Mario

given: Carlo

family: Davies

full_name: Simon Davies

family: van Geuns

full_name: Robert-Jan van Geuns

given: Robert-Jan

family: Eerdmans

full_name: Pedro Eerdmans

given: Pedro

ReferenceCitation: Silber S, Albertsson P, Avilés FF, Camici PG, Colombo A, Hamm C, Jørgensen E, Marco J, Nordrehaug JE, Ruzyllo W, Urban P, Stone GW, Wijns W; Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Guidelines for percutaneous coronary interventions. The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Eur Heart J. 2005 Apr;26(8):804-47. Epub 2005 Mar 15.

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ReferenceCitation: Berger JS, Elliott L, Gallup D, Roe M, Granger CB, Armstrong PW, Simes RJ, White HD, Van de Werf F, Topol EJ, Hochman JS, Newby LK, Harrington RA, Califf RM, Becker RC, Douglas PS. Sex differences in mortality following acute coronary syndromes. JAMA. 2009 Aug 26;302(8):874-82. doi: 10.1001/jama.2009.1227.

ReferenceCitation: Briguori C, Airoldi F, Chieffo A, Carlino M, Montorfano M, Colombo A. Renal function and drug-eluting stent. Int J Cardiol. 2010 Jun 25;142(1):92-4. doi: 10.1016/j.ijcard.2008.11.138. Epub 2009 Jan 15.

ReferenceCitation: Latif F, Kleiman NS, Cohen DJ, Pencina MJ, Yen CH, Cutlip DE, Moliterno DJ, Nassif D, Lopez JJ, Saucedo JF; EVENT Investigators. In-hospital and 1-year outcomes among percutaneous coronary intervention patients with chronic kidney disease in the era of drug-eluting stents: a report from the EVENT (Evaluation of Drug Eluting Stents and Ischemic Events) registry. JACC Cardiovasc Interv. 2009 Jan;2(1):37-45. doi: 10.1016/j.jcin.2008.06.012.

ReferenceCitation: Rosenblum MA, Robbins MJ, Farkouh ME, Winston JA, Kim MC. Diminished benefits of drug-eluting stents versus bare metal stents in patients with severe renal insufficiency. Nephron Clin Pract. 2009;113(3):c198-202. doi: 10.1159/000232602. Epub 2009 Aug 12.

ReferenceCitation: Mehilli J, Dibra A, Kastrati A, Pache J, Dirschinger J, Schömig A; Intracoronary Drug-Eluting Stenting to Abrogate Restenosis in Small Arteries (ISAR-SMART 3) Study Investigators. Randomized trial of paclitaxel- and sirolimus-eluting stents in small coronary vessels. Eur Heart J. 2006 Feb;27(3):260-6. Epub 2006 Jan 9.

ReferenceCitation: Park SW, Lee CW, Hong MK, Kim JJ, Cho GY, Nah DY, Park SJ. Randomized comparison of coronary stenting with optimal balloon angioplasty for treatment of lesions in small coronary arteries. Eur Heart J. 2000 Nov;21(21):1785-9.

ReferenceCitation: Ortolani P, Marzocchi A, Marrozzini C, Palmerini T, Saia F, Taglieri N, Aquilina M, Baldazzi F, Silenzi S, Cooke RM, Reggiani ML, Branzi A. Randomized comparative trial of a thin-strut bare metal cobalt-chromium stent versus a sirolimus-eluting stent for coronary revascularization. Catheter Cardiovasc Interv. 2007 May 1;69(6):790-8.

ReferenceCitation: Tanimoto S, Daemen J, Serruys PW. Update on stents: recent studies on the TAXUS stent system in small vessels. Vasc Health Risk Manag. 2007;3(4):481-90. Review.

ReferenceCitation: Elezi S, Kastrati A, Pache J, Wehinger A, Hadamitzky M, Dirschinger J, Neumann FJ, Schömig A. Diabetes mellitus and the clinical and angiographic outcome after coronary stent placement. J Am Coll Cardiol. 1998 Dec;32(7):1866-73.

ReferenceCitation: Stettler C, Allemann S, Egger M, Windecker S, Meier B, Diem P. Efficacy of drug eluting stents in patients with and without diabetes mellitus: indirect comparison of controlled trials. Heart. 2006 May;92(5):650-7. Epub 2005 Oct 26. Review.

ReferenceCitation: Boccara F, Teiger E, Cohen A. Role of drug eluting stents in diabetic patients. Heart. 2006 May;92(5):579-81. Epub 2006 Jan 31.

ReferenceCitation: Sukhija R, Mehta JL, Sachdeva R. Present status of coronary bifurcation stenting. Clin Cardiol. 2008 Feb;31(2):63-6. Review.

ReferenceCitation: Kim YH, Park SW, Lee SW, Park DW, Yun SC, Lee CW, Hong MK, Kim HS, Ko JK, Park JH, Lee JH, Choi SW, Seong IW, Cho YH, Lee NH, Kim JH, Chun KJ, Park SJ; Long-DES-II Study Investigators. Sirolimus-eluting stent versus paclitaxel-eluting stent for patients with long coronary artery disease. Circulation. 2006 Nov 14;114(20):2148-53. Epub 2006 Oct 23.

ReferenceCitation: Hannan EL, Wu C, Walford G, Culliford AT, Gold JP, Smith CR, Higgins RS, Carlson RE, Jones RH. Drug-eluting stents vs. coronary-artery bypass grafting in multivessel coronary disease. N Engl J Med. 2008 Jan 24;358(4):331-41. doi: 10.1056/NEJMoa071804.

ReferenceCitation: Nakamura S, Nakamura S, Ogawa H, Bae JH, HansCahyadi Y, Udayachalerm W, DTresukosol D, Tansuphaswadikul S, Drug-eluting stents for the treatment of left main coronary artery disease with sirolimus, paclitaxel, zotarolimus, BiolimusA9, EPC capture and everolimus-eluting stent: multicenter registry in Asia (Oral Contributions Georgia World Congress Center, Room B315 Monday, March 15, 2010, 2:00 p.m.-2:12 p.m.). J Am Coll Cardiol 2010;55

ReferenceCitation: Lotan C, Almagor Y, Kuiper K, Suttorp MJ, Wijns W. Sirolimus-eluting stent in chronic total occlusion: the SICTO study. J Interv Cardiol. 2006 Aug;19(4):307-12.

ReferenceCitation: Rahel BM, Suttorp MJ, Laarman GJ, Kiemeneij F, Bal ET, Rensing BJ, Ernst SM, ten Berg JM, Kelder JC, Plokker HW. Primary stenting of occluded native coronary arteries: final results of the Primary Stenting of Occluded Native Coronary Arteries (PRISON) study. Am Heart J. 2004 May;147(5):e22.

ReferenceCitation: Suttorp MJ, Laarman GJ, Rahel BM, Kelder JC, Bosschaert MA, Kiemeneij F, Ten Berg JM, Bal ET, Rensing BJ, Eefting FD, Mast EG. Primary Stenting of Totally Occluded Native Coronary Arteries II (PRISON II): a randomized comparison of bare metal stent implantation with sirolimus-eluting stent implantation for the treatment of total coronary occlusions. Circulation. 2006 Aug 29;114(9):921-8. Epub 2006 Aug 14.

ReferenceCitation: Nakamura S, Nakamura S, Ogawa H, Bae JH, HansCahyadi Y, Udayachalerm W, DTresukosol D, Tansuphaswadikul S, Drug-eluting stents for the treatment of chronic total occlusion: a comparison with sirolimus, paclitaxel, zotarolimus, BiolimusA9, EPC capture and everolimus-eluting stent: multicenter registry in Asia (Poster Contributions Georgia World Congress Center, Hall B5 Monday, March 15, 2010, 9:30 a.m.-10:30 a.m. ). J Am Coll Cardiol 2010;55.

ReferenceCitation: Hamm CW, Braunwald E. A classification of unstable angina revisited. Circulation. 2000 Jul 4;102(1):118-22. Review.

ReferenceCitation: Braunwald E. Unstable angina. A classification. Circulation. 1989 Aug;80(2):410-4.

ReferenceCitation: Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW; Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007 May 1;115(17):2344-51.

ReferenceCitation: TIMI Study Group. The Thrombolysis in Myocardial Infarction (TIMI) trial. Phase I findings. N Engl J Med. 1985 Apr 4;312(14):932-6.

location_country:
Romania
Russian Federation
Denmark
Taiwan
Ukraine
Spain
France
Poland
Lithuania
Indonesia
Slovenia
Chile
Sweden
Netherlands
Bulgaria
Malta
Hungary
Ireland
Germany
United Kingdom
Austria
Brazil
Serbia
Mexico
Czechia
Bangladesh
Georgia
Israel
Egypt
Belarus
Estonia
Latvia

location_facility: Fundação Bahiana de Cardiologia (MC Oliveira Prest

location_facility: National Institute of Cardiovascular Surgery AMS

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: Republican Scientific and Practical Center of Cardiology

location_facility: Hospital Beneficencia Portuguesa de Sao Paulo

location_facility: Instituto do Coração do Triângulo Mineiro

location_facility: Central Clinical Hospital N°2 Russia Railways

location_facility: Gottsegen National Cardiology Institute (GOKI)

location_facility: Hospital of Lithuania University of Health Science

location_facility: Vivantes Netzwerk für Gesundheit gmbH - Humboldt

location_facility: Instituto Nacional De Cardiologia "Ignacio Chávez"

location_facility: State cardiovascular center based on regional clin

location_facility: National Cardiovascular Center Harapan Kita

location_facility: Institute for Cardiovascular Disease Dedinje

location_facility: Frimley Park Hospital NHS Foundation Trust

location_facility: Evangelisch Freikirchliches Krankenhaus und Herzze

location_facility: Academian E.N Meshalkin State Research Institute of circulation Pathology

location_facility: Hospital Lomas de San Luis Internacional

location_facility: Institut Hospitalier Jacques Cartier (ICPS Massy)

location_facility: Vivantes Netzwerk für Gesundheit gmbH - Friedrichs

location_facility: Central Lasarettet i Västerås, Angio/PCI lab. Medi

location_facility: Royal Blackpool hospital (Lancashire Heart Centre)

location_facility: Real e Benemérita Assoção Portuguesa de Beneficênc

location_facility: National Heart Foundation Hospital & Research Institute

location_facility: Hospital Ana Costa (ENDOCOR Serviços Médicos Ltda)

location_facility: Uniklinik Schleswig-Holstein, Campus Kiel

location_facility: Uppsala Akademiska Sjukhus, Kardiologkliniken

location_facility: Southern Health and Social Care Trust Craigavon Ar

location_facility: Saratov Research Institute of science for cardiology

location_facility: Hôpital Europeen Georges Pompidou (HEGP)

location_facility: Invasive Cardiology Laboratory of P. Stradins Clinical University Hospital

location_facility: Military Hospital N3 named by Vishnevsky

location_facility: Hospital Cruz Vermelha Brasileira Filial do Paraná

location_facility: Irmandade da Santa Casa de Misericórdia de Marília

location_facility: Republican Clinical Medical Center (Presidential Hospital)

location_facility: Vivantes Netzwerk für Gesundheit gmbH - Am Urban

location_facility: V Region (Hospital Gustavo Fricke, Hospital Van Buren, Clinica Reñaca)

location_facility: Federal center of heart,blood and endocrinology diseases named by Almazov

location_facility: Invasive Cardiology Laboratory of Clinics "Gailezers" of Riga's Eastern Clinical University Hospital

location_facility: Szpital Klinicznk Przemienienia (University Hospital)

location_facility: Clinique de l'Europe à Amiens (SAS Cardio Amiens)

location_facility: Hospital Clínico Universitario de Salamanca

location_facility: Ev.Bethesda-Johanniter Klinikum Duisburg GmbH

location_facility: Instituto Cardiovascular de Linhares (Unicor)

location_facility: Hospital Universitario Dr. José Eleuterio Gonzalez

location_facility: Hospital Santa Isabel-Sociedade Divina Providência


title: A Multicenter, Randomized, Double-blind Study of Dacarbazine With or Without Genasense in Chemotherapy-naive Subjects With Advanced Melanoma and Low LDH (The AGENDA Trial)

acronym: AGENDA

summary: This study is being performed to prospectively determine whether dacarbazine plus Genasense is significantly better than dacarbazine plus placebo in chemotherapy-naive patients with advanced melanoma and low baseline LDH (LDH less than or equal to 0.8 times the upper limit of normal). LDH is a biomarker strongly associated with improved outcomes in a recent trial of dacarbazine plus Genasense.

enrollment_type: Anticipated

ReferenceCitation: Bedikian AY, Agarwala SS, Gilles E, Itri L, Kay R, Garbe C. The AGENDA Study: A randomized, double-blind study of Genasense plus dacarbazine (DTIC) in chemotherapy-naïve subjects with advanced melanoma and low LDH. Pigment Cell Res. 2007;20:538 [Abstract T-26].

ReferenceCitation: Bedikian AY, Millward M, Pehamberger H, Conry R, Gore M, Trefzer U, Pavlick AC, DeConti R, Hersh EM, Hersey P, Kirkwood JM, Haluska FG; Oblimersen Melanoma Study Group. Bcl-2 antisense (oblimersen sodium) plus dacarbazine in patients with advanced melanoma: the Oblimersen Melanoma Study Group. J Clin Oncol. 2006 Oct 10;24(29):4738-45. Epub 2006 Sep 11.

lead_sponsor: Genta Incorporated

location_country:
Italy
Austria
United States
Switzerland
United Kingdom
Germany
France
Poland
Australia
Spain
Canada
Czech Republic

location_facility: MD Anderson Cancer Center at University of Texas

location_facility: Klinik fur Dermatologie und Allergologie der Ruhr-Universitat Bochum

location_facility: Charles University, Dermatology Department

location_facility: Klinik fur Dermatologie, Allergologie und Venerologie, Universitatsklinikum Essen

location_facility: Hematology Oncology Centers of the Northern Rockies

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Istituto Nazionale dei Tumori "G. Pascale"

location_facility: Azienda Ospedaliera Universitaria di Siena

location_facility: University of South Alabama Hospital, Mitchell Cancer Institute

location_facility: Morristown Memorial - Atlantic Healthcare System

location_facility: Nottingham University Hospitals NHS Trust, City Campus

location_facility: Klinik und Poliklinik fur Hautkrankheiten

location_facility: CHU de Grenoble, Hopital Albert Michallon

location_facility: Klinik und Poliklinik fur Dermatologie und Venerologie

location_facility: San Diego Pacific Oncology and Hematology Associates Inc.

location_facility: Sydney Cancer Center, Royal Prince Alfred Hospital

location_facility: Universitatsklinik fur Dermatologie und Venerologie, Medizinische Universitat Innsbruck

location_facility: Medical University of Vienna, Vienna General Hospital

location_facility: Hospital of the University of Schleswig-Holstein

location_facility: Siouxland Hematology Oncology Associates

location_facility: Universitatsklinikum Giessen und Marburg GmbH, Klinik fur Dermatologie und Allergologie

location_facility: Klinikum der Friedrich-Schiller-Universitat Jena

location_facility: Vivantes Klinikum Neukoln, Klinik fur Dermatologie und Venerologie


ReferenceCitation: Oza AM, Selle F, Davidenko I, Korach J, Mendiola C, Pautier P, Chmielowska E, Bamias A, DeCensi A, Zvirbule Z, González-Martín A, Hegg R, Joly F, Zamagni C, Gadducci A, Martin N, Robb S, Colombo N. Efficacy and Safety of Bevacizumab-Containing Therapy in Newly Diagnosed Ovarian Cancer: ROSiA Single-Arm Phase 3B Study. Int J Gynecol Cancer. 2017 Jan;27(1):50-58. doi: 10.1097/IGC.0000000000000836.

family: Oza

full_name: Amit M. Oza

given: Amit M.

family: Selle

full_name: Frédéric Selle

given: Frédéric

family: Davidenko

full_name: Irina Davidenko

given: Irina

family: Korach

full_name: Jacob Korach

given: Jacob

family: Mendiola

full_name: Cesar Mendiola

given: Cesar

family: Pautier

full_name: Patricia Pautier

given: Patricia

family: Chmielowska

full_name: Ewa Chmielowska

given: Ewa

family: Bamias

full_name: Aristotelis Bamias

given: Aristotelis

family: DeCensi

full_name: Andrea DeCensi

given: Andrea

family: Zvirbule

full_name: Zanete Zvirbule

given: Zanete

family: González-Martín

full_name: Antonio González-Martín

given: Antonio

family: Hegg

full_name: Roberto Hegg

family: Joly

full_name: Florence Joly

given: Florence

family: Zamagni

full_name: Claudio Zamagni

given: Claudio

family: Gadducci

full_name: Angiolo Gadducci

given: Angiolo

family: Martin

full_name: Nicolas Martin

given: Nicolas

family: Robb

full_name: Stephen Robb

given: Stephen

family: Colombo

full_name: Nicoletta Colombo

given: Nicoletta

journal_name: International Journal of Gynecologic Cancer

oa_host_type: repository

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Hoffmann-La Roche

location_country: Macedonia, The Former Yugoslav Republic of

title: Global Study to Assess the Addition of Bevacizumab to Carboplatin and Paclitaxel as Front-line Treatment of Epithelial Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Carcinoma

summary: This open-label, non-comparative, multi-center study will assess the safety profile and efficacy of Avastin (bevacizumab) when added to carboplatin and paclitaxel therapy in participants with epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma. Participants will receive 15 milligrams/kilogram (mg/kg) Avastin intravenously (IV) on Day 1 of every cycle for up to 36 cycles of 3 weeks each, carboplatin (area under the plasma concentration-time curve [AUC] 5-6 mg/ml/min) on Day 1 every 3 weeks for a maximum of 8 cycles and paclitaxel 175 milligram per square meter (mg/m^2) on Day 1 every 3 weeks or 80 mg/m^2 every week for a maximum of 8 cycles. The anticipated time on study drug will be 108 weeks or until disease progression or unacceptable toxicity.


type: EudraCT Number

type: Other Identifier

title: A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Pazopanib as Adjuvant Therapy for Subjects With Localized or Locally Advanced RCC Following Nephrectomy

acronym: PROTECT

summary: This randomized Phase III study is to evaluate whether pazopanib compared with placebo can prevent or delay recurrence of kidney cancer in patients with moderately high or high risk of developing recurrence after undergoing kidney cancer surgery.

ReferenceCitation: Sternberg CN, Davis ID, Mardiak J, Szczylik C, Lee E, Wagstaff J, Barrios CH, Salman P, Gladkov OA, Kavina A, Zarbá JJ, Chen M, McCann L, Pandite L, Roychowdhury DF, Hawkins RE. Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial. J Clin Oncol. 2010 Feb 20;28(6):1061-8. doi: 10.1200/JCO.2009.23.9764. Epub 2010 Jan 25.

ReferenceCitation: Motzer RJ, Russo P, Haas N, Doehn C, Donskov F, Gross-Goupil M, Varlamov S, Kopyltsov E, Lee JL, Lim HY, Melichar B, Zemanova M, Rini B, Choueiri TK, Wood L, Reaume MN, Stenzl A, Chowdhury S, McDermott R, Michael A, Izquierdo M, Aimone P, Zhang H, Sternberg CN; PROTECT study investigators. Adjuvant Pazopanib Versus Placebo After Nephrectomy in Patients With Localized or Locally Advanced Renal Cell Carcinoma: Final Overall Survival Analysis of the Phase 3 PROTECT Trial. Eur Urol. 2021 Mar;79(3):334-338. doi: 10.1016/j.eururo.2020.12.029. Epub 2021 Jan 15.

family: Motzer

full_name: Robert J. Motzer

given: Robert J.

family: Russo

full_name: Paul Russo

given: Paul

family: Haas

full_name: Naomi Haas

given: Naomi

family: Doehn

full_name: Christian Doehn

given: Christian

family: Donskov

full_name: Frede Donskov

given: Frede

family: Gross-Goupil

full_name: Marine Gross-Goupil

given: Marine

family: Varlamov

full_name: Sergei Varlamov

given: Sergei

family: Kopyltsov

full_name: Evgeny Kopyltsov

given: Evgeny

family: Lee

full_name: Jae Lyun Lee

given: Jae Lyun

family: Lim

full_name: Ho Yeong Lim

given: Ho Yeong

family: Melichar

full_name: Bohuslav Melichar

given: Bohuslav

family: Zemanova

full_name: Milada Zemanova

given: Milada

family: Rini

full_name: Brian Rini

given: Brian

family: Choueiri

full_name: Toni K. Choueiri

given: Toni K.

family: Wood

full_name: Lori Wood

given: Lori

family: Reaume

full_name: M. Neil Reaume

given: M. Neil

family: Stenzl

full_name: Arnulf Stenzl

given: Arnulf

family: Chowdhury

full_name: Simon Chowdhury

given: Simon

family: McDermott

full_name: Ray McDermott

given: Ray

family: Michael

full_name: Agnieszka Michael

given: Agnieszka

family: Izquierdo

full_name: Miguel Izquierdo

given: Miguel

family: Aimone

full_name: Paola Aimone

given: Paola

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Luxembourg
Greece
Belgium
Russian Federation
Denmark
France
Japan
Poland
Slovakia
Argentina
Canada
Korea, Republic of
Chile
Hungary
Ireland
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Czechia
Israel
Spain
Turkey


title: A Prospective Observational Safety Study in Patients With Advanced Prostate Cancer Treated With FIRMAGON (Degarelix) or a GnRH Agonist

summary: This study is a large observational study, set-up to observe how long-term treatment with FIRMAGON (hormone regulator) compare to other treatments in regards to cardiovascular events, changes in bone density, changes in blood sugar levels or liver enzyme levels in subjects with prostate cancer. Subjects will be treated according to their routine clinical care and not dictated by the study. As the study is observational in nature, the study will collect data relating to the events specified above. Subjects that agree to this study will be followed-up for 5 years. Subject data will be collected every 3 months for the first 2 years and every 6 months for the last 3 years.

lead_sponsor: Ferring Pharmaceuticals

location_country:
Italy
Switzerland
Netherlands
Finland
France
Greece
Slovakia
Norway
Hungary
Belgium
Ireland
Portugal
Denmark
Germany
United Kingdom

location_facility: General Hospital of Volos "Achillopouleio"

location_facility: Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg

location_facility: CENTRUM UROLOGIE Povazska Bystrica s.r.o

location_facility: Olso Universitetssykehus HF, Radiumhospitalet

location_facility: Centre Hospitalier d'Athis Mons site Caron

location_facility: Azienda Sanitaria Regionale del Molise (ASREM)

location_facility: Istituto Nazionale Tumori "Regina Elena"

location_facility: "G. Gennimtas" General Hospital of Athens

location_facility: Aghios Andreas General Hospital of Patras

location_facility: General Hospital of Athens "Ag. Olga" - Konstantopouleion

location_facility: Amalia Fleming General Hospital of Athens

location_facility: Papageorgiou General Hospital of Thessaloniki

location_facility: Miskolci Semmelweis Ignác Egészségügyi Központ és Egyetemi Oktató Kórház Nonprofit Kft

location_facility: Helse Nordmore og Romsdal HF, Kristiansund Sykehus

location_facility: "Agios Savas" Anticancer-Oncology Hospital of Athens

location_facility: Vestre Viken HF, Sykehuset Asker og Baerum

location_facility: 2nd IKA-ETAM "Panagia" General Hospital of Thessaloniki

location_facility: Centre Hospitalier Universitaire Ambroise Paré

location_facility: Azienda Ospedaliera Mater Domini di Catanzaro

location_facility: Azienda Ospedaliera Universitaria OO.RR. S.Giovanni di Dio e Ruggi d'Aragona

location_facility: "G. Gennimtas" General Hospital of Thessaloniki

location_facility: Gemeinschaftspraxis Dres Effert und Benedic


title: A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multinational Trial, to Assess the Prevention of Thrombotic Events With Ticagrelor Compared to Placebo on a Background of Acetyl Salicylic Acid (ASA) Therapy in Patients With History of Myocardial Infarction

acronym: PEGASUS

summary: This study is being carried out to see if a new drug called ticagrelor given twice daily in addition to the ASA therapy decreases the frequency of cardiovascular events (e.g., death from heart disease, heart attack, or stroke).

primary_purpose: Prevention

ReferenceCitation: Bonaca MP, Bhatt DL, Cohen M, Steg PG, Storey RF, Jensen EC, Magnani G, Bansilal S, Fish MP, Im K, Bengtsson O, Oude Ophuis T, Budaj A, Theroux P, Ruda M, Hamm C, Goto S, Spinar J, Nicolau JC, Kiss RG, Murphy SA, Wiviott SD, Held P, Braunwald E, Sabatine MS; PEGASUS-TIMI 54 Steering Committee and Investigators. Long-term use of ticagrelor in patients with prior myocardial infarction. N Engl J Med. 2015 May 7;372(19):1791-800. doi: 10.1056/NEJMoa1500857. Epub 2015 Mar 14.

family: Bonaca

full_name: Marc P. Bonaca

given: Marc P.

family: Bhatt

full_name: Deepak L. Bhatt

given: Deepak L.

family: Cohen

full_name: Marc Cohen

given: Marc

family: Steg

full_name: Philippe Gabriel Steg

given: Philippe Gabriel

family: Storey

full_name: Robert F. Storey

given: Robert F.

family: Jensen

full_name: Eva C. Jensen

given: Eva C.

family: Magnani

full_name: Giulia Magnani

given: Giulia

family: Bansilal

full_name: Sameer Bansilal

given: Sameer

family: Fish

full_name: M. Polly Fish

given: M. Polly

family: Im

full_name: Kyungah Im

given: Kyungah

family: Bengtsson

full_name: Olof Bengtsson

given: Olof

family: Ophuis

full_name: Ton Oude Ophuis

given: Ton Oude

family: Budaj

full_name: Andrzej Budaj

given: Andrzej

family: Theroux

full_name: Pierre Theroux

given: Pierre

family: Ruda

full_name: Mikhail Ruda

given: Mikhail

family: Hamm

full_name: Christian Hamm

given: Christian

family: Goto

full_name: Shinya Goto

given: Shinya

family: Spinar

full_name: Jindrich Spinar

given: Jindrich

family: Nicolau

full_name: José Carlos Nicolau

given: José Carlos

family: Kiss

full_name: Robert G. Kiss

given: Robert G.

family: Murphy

full_name: Sabina A. Murphy

given: Sabina A.

family: Wiviott

full_name: Stephen D. Wiviott

given: Stephen D.

family: Held

full_name: Peter Held

given: Peter

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

repositories_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

title: Long-Term Use of Ticagrelor in Patients with Prior Myocardial Infarction

ReferenceCitation: Bergmark BA, Bhatt DL, Steg PG, Budaj A, Storey RF, Gurmu Y, Kuder JF, Im K, Magnani G, Oude Ophuis T, Hamm C, Špinar J, Kiss RG, Van de Werf FJ, Montalescot G, Johanson P, Braunwald E, Sabatine MS, Bonaca MP. Long-Term Ticagrelor in Patients With Prior Coronary Stenting in the PEGASUS-TIMI 54 Trial. J Am Heart Assoc. 2021 Sep 7;10(17):e020446. doi: 10.1161/JAHA.120.020446. Epub 2021 Aug 21.

name: TIMI Study Group Cardiovascular Medicine Department of Medicine Brigham and Women’s HospitalHarvard Medical School Boston MA

name: French Alliance for Cardiovascular TrialsAP‐HPHôpital BichatUniversité de ParisInstitut National de la Santé et de la Recherche Médicale U‐1148 Paris France

name: National Heart and Lung InstituteRoyal Brompton HospitalImperial College London London UK

name: Centre of Postgraduate Medical Education Grochowski Hospital Warsaw Poland

name: University Hospital of Parma Parma Italy

name: Canisius‐Wilhelmina Hospital Nijmegen the Netherlands

name: Kerckhoff Heart CenterBad NauheimUniversity of Giessen Giessen Germany

name: University hospital St. Ann, Pekarska and Medical faculty Brno Czech Republic

name: Department of Cardiology Military Hospital Budapest Hungary

name: Sorbonne Université, Paris 6ACTION Study GroupINSERM‐UMRS 1166Institut de CardiologiePitié‐Salpêtrière Hospital (AP‐HP) Paris France

name: Colorado Prevention Center (CPC) Clinical Research the Department of Medicine Division of Cardiovascular Medicine University of Colorado Anschutz Medical Campus Aurora CO

journal_name: Journal of the American Heart Association

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Sorbonne Paris Nord

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Sorbonne Paris Nord

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Long‐Term Ticagrelor in Patients With Prior Coronary Stenting in the PEGASUS‐TIMI 54 Trial

ReferenceCitation: Magnani G, Ardissino D, Im K, Budaj A, Storey RF, Steg PG, Bhatt DL, Cohen M, Oude Ophius T, Goudev A, Parkhomenko A, Kamensky G, Angiolillo DJ, López-Sendón J, Johanson P, Braunwald E, Sabatine MS, Bonaca MP. Predictors, Type, and Impact of Bleeding on the Net Clinical Benefit of Long-Term Ticagrelor in Stable Patients With Prior Myocardial Infarction. J Am Heart Assoc. 2021 Feb 16;10(4):e017008. doi: 10.1161/JAHA.120.017008. Epub 2021 Feb 9.

name: TIMI Study GroupBrigham and Women’s Hospital Boston MA

name: Dept de Cardiologie Hôpital BichatHôpitaux de Paris Paris France

name: Newark Beth Israel Medical CenterRutgers Medical school Newark NJ

name: Canisius Wilhelmina Ziekenhuis Nijmegen the Netherlands

name: Queen Giovanna University Hospital St Sofia Bulgaria

name: University Hospital Bratislava Bratislava Slovakia

name: University of FloridaCollege of Medicine Jacksonville FL

name: University of ColoradoSchool of Medicine Aurora CO

title: Predictors, Type, and Impact of Bleeding on the Net Clinical Benefit of Long‐Term Ticagrelor in Stable Patients With Prior Myocardial Infarction

ReferenceCitation: Furtado RHM, Venkateswaran RV, Nicolau JC, Gurmu Y, Bhatt DL, Storey RF, Steg PG, Magnani G, Goto S, Dellborg M, Kamensky G, Isaza D, Aylward P, Johanson P, Bonaca MP. Caffeinated Beverage Intake, Dyspnea With Ticagrelor, and Cardiovascular Outcomes: Insights From the PEGASUS-TIMI 54 Trial. J Am Heart Assoc. 2020 May 18;9(10):e015785. doi: 10.1161/JAHA.119.015785. Epub 2020 May 15.

name: TIMI Study Group Brigham and Women’s Hospital Harvard Medical School Boston MA

name: Instituto do Coracao (InCor) Hospital das Clinicas da Faculdade de Medicina Universidade de Sao Paulo Brazil

name: Hospital Albert Einstein Sao Paulo Brazil

name: Université de Paris, and Assistance Publique‐Hôpitaux de Paris Paris France

name: Department of Medicine (Cardiology) Tokai University Hospital Isehara Japan

name: Sahlgrenska Academy University of Gothenburg Sweden

name: Department of Non‐invasive Cardiovascular Diagnostics University Hospital Bratislava Bratislava Slovakia

name: Fundacion Cardioinfantil Instituto de Cardiologia Bogotá Colombia

name: South Australian Health and Medical Research Institute Flinders University and Medical Centre Adelaide Australia

name: CPC Clinical Research and Vascular Research Unity University of Colorado Denver CO

title: Caffeinated Beverage Intake, Dyspnea With Ticagrelor, and Cardiovascular Outcomes: Insights From the PEGASUS‐TIMI 54 Trial

ReferenceCitation: Gencer B, Li XS, Gurmu Y, Bonaca MP, Morrow DA, Cohen M, Bhatt DL, Steg PG, Storey RF, Johanson P, Wang Z, Hazen SL, Sabatine MS. Gut Microbiota-Dependent Trimethylamine N-oxide and Cardiovascular Outcomes in Patients With Prior Myocardial Infarction: A Nested Case Control Study From the PEGASUS-TIMI 54 Trial. J Am Heart Assoc. 2020 May 18;9(10):e015331. doi: 10.1161/JAHA.119.015331. Epub 2020 May 5.

name: TIMI Study Group Division of Cardiovascular Medicine Brigham and Women’s Hospital Harvard Medical School Boston MA

name: Department of Cardiovascular and Metabolic Sciences Lerner Research Institute Cleveland Clinic Cleveland OH

name: CPC Clinical Research Division of Cardiovascular Medicine University of Colorado Denver CO

name: Newark Beth Israel Medical Center Rutgers‐New Jersey Medical School Newark NJ

name: Cardiovascular Research Unit Department of Infection, Immunity and Cardiovascular Disease University of Sheffield United Kingdom

name: Department of Cardiovascular Medicine, Heart and Vascular Institute Cleveland Clinic Cleveland OH

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

title: Gut Microbiota‐Dependent Trimethylamine N‐oxide and Cardiovascular Outcomes in Patients With Prior Myocardial Infarction: A Nested Case Control Study From the PEGASUS‐TIMI 54 Trial

ReferenceCitation: Furtado RHM, Nicolau JC, Magnani G, Im K, Bhatt DL, Storey RF, Steg PG, Spinar J, Budaj A, Kontny F, Corbalan R, Kiss RG, Abola MT, Johanson P, Jensen EC, Braunwald E, Sabatine MS, Bonaca MP. Long-term ticagrelor for secondary prevention in patients with prior myocardial infarction and no history of coronary stenting: insights from PEGASUS-TIMI 54. Eur Heart J. 2020 May 1;41(17):1625-1632. doi: 10.1093/eurheartj/ehz821.

name: TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, USA

name: Instituto do Coracao (InCor), Hospital das Clinicas da Faculdade de Medicina, Universidade de Sao Paulo, Av Dr Eneas de Carvalho Aguiar 44, 05403 Sao Paulo, Brazil

name: University Hospital of Parma, Via Gramsci, 14, 43126 Parma PR, Italy

name: University of Sheffield, Western Bank, Sheffield S10 2TN, UK

name: Assistance Publique-Hôpitaux de Paris, 3 Avenue Victoria, 75004 Paris, France

name: University Hospital Brno, 20 Jihlavska, Brno, Czech Republic

name: Centre of Postgraduate Medical Education, Grochowski Hospital, Grenadierów 51/59, 04-073 Warsaw, Poland

name: Department of Cardiology, Stavanger University Hospital, Gerd Ragna Bloch Thorsens gate 8, Stavanger, Norway

name: Drammen Heart Center, Dronninggata 28, 3004 Drammen, Norway

name: Cardiovascular Division, Faculty of Medicine, Pontificia Universidad Católica de Chile, Lira 40, Santiago, Chile

name: Department of Cardiology, Military Hospital, Róbert Károly krt., 1134 Budapest, Hungary

name: College of Medicine, University of the Philippines/Philippine Heart Center, East, Quezon City, Metro Manila, Philippines

name: CPC Clinical Research, University of Colorado School of Medicine, 13199 E Montview Blvd Suite 200, Aurora, CO, USA

ReferenceCitation: Dellborg M, Bonaca MP, Storey RF, Steg PG, Im KA, Cohen M, Bhatt DL, Oude Ophuis T, Budaj A, Hamm C, Spinar J, Kiss RG, Lopez-Sendon J, Kamensky G, Van de Werf F, Ardissino D, Kontny F, Montalescot G, Johanson P, Bengtsson O, Himmelmann A, Braunwald E, Sabatine MS. Efficacy and safety with ticagrelor in patients with prior myocardial infarction in the approved European label: insights from PEGASUS-TIMI 54. Eur Heart J Cardiovasc Pharmacother. 2019 Oct 1;5(4):200-206. doi: 10.1093/ehjcvp/pvz020.

name: Department of Medicine, University of Gothenburg, Institute of Medicine, Sahlgrenska Academy, Sahlgrenska University Hospital/Östra, Diagnosvägen 11, Gothenburg, Sweden

name: Harvard Medical School, TIMI Study Group, Boston, MA, USA

name: University Paris Diderot, INSERM Unite 1148, Hôptial Bichat, Paris, France

name: Newark Beth Israel Medical Center, Rutgers New Jersey Medical School, Newark, NJ, USA

name: Canisius-Wilhelmina Hospital, Nijmegen, the Netherlands

name: Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland

name: Kerckhoff Heart Center, Bad Nauheim, University of Giessen, Giessen, Germany

name: University Hospital, Jihlavska, Brno, Czech Republic

name: Department of Cardiology, Military Hospital, Budapest, Hungary

name: Cardiovascular Division, University Hospital La Paz, Madrid, Spain

name: Department of Noninvasive Cardiovascular Diagnostics, Vth Internal Clinic, University Hospital Bratislava, Bratislava, Slovakia

name: Division of Cardiology, Azienda Ospedaliero Universitaria di Parma, Parma, Italy

name: Department of Cardiology, Stavanger University Hospital, Stavanger, Norway

name: Sorbonne Université Paris 6, ACTION Study Group, INSERM-UMRS 1166, Institut de Cardiologie, Pitié-Salpêtrière Hospital (AP-HP), Paris, France

journal_name: European Heart Journal - Cardiovascular Pharmacotherapy

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Mines Nantes

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Audencia Business School

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Audencia Business School

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Mines Nantes

ReferenceCitation: Bonaca MP, Wiviott SD, Morrow DA, Steg PG, Hamm C, Bhatt DL, Storey RF, Cohen M, Kuder J, Im K, Magnani G, Budaj A, Nicolau JC, Parkhomenko A, López-Sendón J, Dellborg M, Diaz R, Van de Werf F, Corbalán R, Goudev A, Jensen EC, Johanson P, Braunwald E, Sabatine MS. Reduction in Subtypes and Sizes of Myocardial Infarction With Ticagrelor in PEGASUS-TIMI 54. J Am Heart Assoc. 2018 Nov 20;7(22):e009260. doi: 10.1161/JAHA.118.009260.

name: TIMI Study Group Brigham and Women's Hospital Boston MA

name: FACT, DHU FIRE Hôpital Bichat Assistance Publique‐Hôpitaux de Paris Paris France

name: Department of Medicine Kerckhoff Heart Center BadNauheim Germany

name: Department of Medicine University of Sheffield United Kingdom

name: UniversitätsSpital Zürich (USZ) & Zürich Heart House University Hospital of Zurich Switzerland

name: Postgraduate Medical School Grochowski Hospital Warsaw Poland

name: Heart Institute (InCor) University of São Paulo Medical School São Paulo Brazil

name: Department of Medicine Institute of Cardiology Kiev Ukraine

name: Department of Medicine Hosp Univrio La Paz Madrid Spain

name: Sahlgrenska Acad University of Gothenburg Sweden

name: Department of Medicine ECLA (Estudios Clínicos Latino América) Rosario Argentina

name: Department of Medicine University of Leuven Belgium

name: Department of Medicine Pontificia Univ Catolica de Chile Santiago Chile

name: Medical University of Sofia Queen Ioanna University Hospital Sofia Bulgaria

title: Reduction in Subtypes and Sizes of Myocardial Infarction With Ticagrelor in PEGASUS–TIMI 54

ReferenceCitation: Bansilal S, Bonaca MP, Cornel JH, Storey RF, Bhatt DL, Steg PG, Im K, Murphy SA, Angiolillo DJ, Kiss RG, Parkhomenko AN, Lopez-Sendon J, Isaza D, Goudev A, Kontny F, Held P, Jensen EC, Braunwald E, Sabatine MS, Oude Ophuis AJ. Ticagrelor for Secondary Prevention of Atherothrombotic Events in Patients With Multivessel Coronary Disease. J Am Coll Cardiol. 2018 Feb 6;71(5):489-496. doi: 10.1016/j.jacc.2017.11.050.

ReferenceCitation: Cavallari I, Morrow DA, Creager MA, Olin J, Bhatt DL, Steg PG, Storey RF, Cohen M, Scirica BS, Piazza G, Goodrich EL, Braunwald E, Sabatine MS, Bonaca MP. Frequency, Predictors, and Impact of Combined Antiplatelet Therapy on Venous Thromboembolism in Patients With Symptomatic Atherosclerosis. Circulation. 2018 Feb 13;137(7):684-692. doi: 10.1161/CIRCULATIONAHA.117.031062. Epub 2017 Oct 30.

name: TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA (I.C., D.A.M., D.L.B., B.S.S., E.L.G., E.B., M.S.S., M.P.B.)

name: Department of Cardiovascular Sciences, Campus Bio-Medico University of Rome, Italy (I.C.)

name: Dartmouth-Hitchcock Heart and Vascular Center, Geisel School of Medicine at Dartmouth, Lebanon, NH (M.A.C.)

name: Wiener Cardiovascular Institute and Marie-Jose and Henry R. Kravis Center for Cardiovascular Health, Mt Sinai School of Medicine, New York (J.O.)

name: French Alliance for Cardiovascular Trials, Département Hospitalo-Universitaire Fibrosis, Inflammation, Remodeling, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, France (P.G.S.)

name: Université Paris-Diderot, Sorbonne Paris Cité, France (P.G.S.)

name: Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, United Kingdom (R.F.S.)

name: Department of Medicine, Cardiovascular Division, Newark Beth Israel Medical Center, Rutgers-New Jersey Medical School (M.C.)

name: Cardiovascular Division, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA (G.P.)

ReferenceCitation: Bonaca MP, Storey RF, Theroux P, Steg PG, Bhatt DL, Cohen MC, Im K, Murphy SA, Magnani G, Ophuis TO, Rudah M, Parkhomenko A, Isaza D, Kamensky G, Goudev A, Montalescot G, Jensen EC, Johanson P, Braunwald E, Sabatine MS. Efficacy and Safety of Ticagrelor Over Time in Patients With Prior MI in PEGASUS-TIMI 54. J Am Coll Cardiol. 2017 Sep 12;70(11):1368-1375. doi: 10.1016/j.jacc.2017.07.768.

title: Efficacy and Safety of Ticagrelor Over Time in Patients With Prior MI in PEGASUS-TIMI 54

ReferenceCitation: Magnuson EA, Li H, Wang K, Vilain K, Shafiq A, Bonaca MP, Bhatt DL, Cohen M, Steg PG, Storey RF, Braunwald E, Sabatine MS, Cohen DJ; PEGASUS-TIMI 54 Trial Investigators. Cost-Effectiveness of Long-Term Ticagrelor in Patients With Prior Myocardial Infarction: Results From the PEGASUS-TIMI 54 Trial. J Am Coll Cardiol. 2017 Aug 1;70(5):527-538. doi: 10.1016/j.jacc.2017.05.063.

title: Cost-Effectiveness of Long-Term Ticagrelor in Patients With Prior Myocardial Infarction

ReferenceCitation: Thomas MR, Angiolillo DJ, Bonaca MP, Ajjan RA, Judge HM, Rollini F, Franchi F, Ahsan AJ, Bhatt DL, Kuder JF, Steg PG, Cohen M, Muthusamy R, Sabatine MS, Storey RF. Consistent platelet inhibition with ticagrelor 60 mg twice-daily following myocardial infarction regardless of diabetes status. Thromb Haemost. 2017 May 3;117(5):940-947. doi: 10.1160/TH16-09-0703. Epub 2017 Mar 16.

repository_institution: University of Birmingham - University of Birmingham Research Portal

repositories_institution: University of Birmingham - University of Birmingham Research Portal

ReferenceCitation: Bonaca MP, Goto S, Bhatt DL, Steg PG, Storey RF, Cohen M, Goodrich E, Mauri L, Ophuis TO, Ruda M, Špinar J, Seung KB, Hu D, Dalby AJ, Jensen E, Held P, Morrow DA, Braunwald E, Sabatine MS. Prevention of Stroke with Ticagrelor in Patients with Prior Myocardial Infarction: Insights from PEGASUS-TIMI 54 (Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction 54). Circulation. 2016 Sep 20;134(12):861-71. doi: 10.1161/CIRCULATIONAHA.116.024637. Epub 2016 Aug 30.

name: From TIMI Study Group, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA (M.P.B., D.L.B., E.G., D.A.M., E.B., M.S.); Tokai University School of Medicine; Institute of Medical Science, Isehara, Japan (S.G.); FACT, DHU-FIRE INSERM Unité 1148, Assistance Publique–Hôpitaux de Paris and Université Paris Diderot, Paris, France, and NHLI Imperial College, Royal Brompton Hospital, London, UK (P.G.S.); University of Sheffield, United Kingdom (R.F.S.); Division of Cardiology, Newark Beth Israel...

title: Prevention of Stroke with Ticagrelor in Patients with Prior Myocardial Infarction

ReferenceCitation: Bonaca MP, Bhatt DL, Oude Ophuis T, Steg PG, Storey R, Cohen M, Kuder J, Im K, Magnani G, Budaj A, Theroux P, Hamm C, Špinar J, Kiss RG, Dalby AJ, Medina FA, Kontny F, Aylward PE, Jensen EC, Held P, Braunwald E, Sabatine MS. Long-term Tolerability of Ticagrelor for the Secondary Prevention of Major Adverse Cardiovascular Events: A Secondary Analysis of the PEGASUS-TIMI 54 Trial. JAMA Cardiol. 2016 Jul 1;1(4):425-32. doi: 10.1001/jamacardio.2016.1017.

name: TIMI Study Group, Brigham and Women’s Hospital Heart and Vascular Center, Boston, Massachusetts

name: Department of Cardiology, CWZ Hospital, Nijmegen, the Netherlands

name: Département Hospitalo Universitaire FIRE, AP-HP, Hôpital Bichat, Paris, France4Université Paris–Diderot, Sorbonne Paris Cité, Paris, France

name: Department of Cardiovascular Science, University of Sheffield, Sheffield, England

name: Cardiovascular Division, Newark Beth Israel Medical Center, Rutgers–New Jersey Medical School, Newark, New Jersey

name: Montreal Heart Institute, University of Montreal, Montreal, Quebec, Canada

name: Department of Cardiology, Kerckhoff Heart Center, Bad Nauheim, Germany10University of Giessen, Giessen, Hesse, Germany

name: Internal Cardiology Department, University Hospital and Medical Faculty, Brno, Czech Republic

name: South African Cardiology Clinical Trials Group, Milpark Hospital, Johannesburg, South Africa

name: Departamento de Clínicas Médicas, Hospital Nacional Cayetano Heredia, San Martin de Porres, Lima, Peru

name: South Australian Health and Medical Research Institute, Flinders University, Adelaide, Australia

name: AstraZeneca Research and Development, Mölndal, Sweden

name: TIMI Study Group, Brigham and Women’s Hospital Heart and Vascular Center, Boston, Massachusetts18Deputy Editor, JAMA Cardiology

title: Long-term Tolerability of Ticagrelor for the Secondary Prevention of Major Adverse Cardiovascular Events

ReferenceCitation: Held P, Himmelmann A, Ditmarsch M. Ticagrelor for the treatment of atherosclerotic disease: insights from the PARTHENON clinical development program. Future Cardiol. 2016 Jul;12(4):405-18. doi: 10.2217/fca-2016-0028. Epub 2016 May 10. Review.

name: Global Medicines Development, AstraZeneca Gothenburg, Pepparedsleden 1, SE-431 83 Mölndal, Sweden

ReferenceCitation: Bonaca MP, Bhatt DL, Storey RF, Steg PG, Cohen M, Kuder J, Goodrich E, Nicolau JC, Parkhomenko A, López-Sendón J, Dellborg M, Dalby A, Špinar J, Aylward P, Corbalán R, Abola MTB, Jensen EC, Held P, Braunwald E, Sabatine MS. Ticagrelor for Prevention of Ischemic Events After Myocardial Infarction in Patients With Peripheral Artery Disease. J Am Coll Cardiol. 2016 Jun 14;67(23):2719-2728. doi: 10.1016/j.jacc.2016.03.524. Epub 2016 Apr 1.

ReferenceCitation: Bhatt DL, Bonaca MP, Bansilal S, Angiolillo DJ, Cohen M, Storey RF, Im K, Murphy SA, Held P, Braunwald E, Sabatine MS, Steg PG. Reduction in Ischemic Events With Ticagrelor in Diabetic Patients With Prior Myocardial Infarction in PEGASUS-TIMI 54. J Am Coll Cardiol. 2016 Jun 14;67(23):2732-2740. doi: 10.1016/j.jacc.2016.03.529. Epub 2016 Apr 1.

title: Reduction in Ischemic Events With Ticagrelor in Diabetic Patients With Prior Myocardial Infarction in PEGASUS–TIMI 54

ReferenceCitation: Bonaca MP, Bhatt DL, Steg PG, Storey RF, Cohen M, Im K, Oude Ophuis T, Budaj A, Goto S, López-Sendón J, Diaz R, Dalby A, Van de Werf F, Ardissino D, Montalescot G, Aylward P, Magnani G, Jensen EC, Held P, Braunwald E, Sabatine MS. Ischaemic risk and efficacy of ticagrelor in relation to time from P2Y12 inhibitor withdrawal in patients with prior myocardial infarction: insights from PEGASUS-TIMI 54. Eur Heart J. 2016 Apr 7;37(14):1133-42. doi: 10.1093/eurheartj/ehv531. Epub 2015 Oct 21.

title: Ischaemic risk and efficacy of ticagrelor in relation to time from P2Y12inhibitor withdrawal in patients with prior myocardial infarction: insights from PEGASUS-TIMI 54

ReferenceCitation: Bonaca MP, Bhatt DL, Braunwald E, Cohen M, Steg PG, Storey RF, Held P, Jensen EC, Sabatine MS. Design and rationale for the Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction 54 (PEGASUS-TIMI 54) trial. Am Heart J. 2014 Apr;167(4):437-444.e5. doi: 10.1016/j.ahj.2013.12.020. Epub 2014 Jan 6. Review.

title: Design and rationale for the Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin–Thrombolysis in Myocardial Infarction 54 (PEGASUS-TIMI 54) trial

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