Trial to Assess the Effects of Vorapaxar (SCH 530348; MK-5348) in Preventing Heart Attack and Stroke in Patients With Atherosclerosis (TRA 2°P - TIMI 50) (P04737)
NCT ID: NCT00526474
Last Updated: 2018-09-21
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
26449 participants
Study Classification
INTERVENTIONAL
Study Start Date
2007-09-01
Study Completion Date
2011-12-01
Brief Summary
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The study is designed to determine whether vorapaxar, when added to the existing standard of care (SOC) for preventing heart attack and stroke (eg, aspirin, clopidogrel) in participants with a known history of atherosclerosis, will yield additional benefit over the existing standard of care without vorapaxar in preventing heart attack and stroke.
The study is also designed to assess risk of bleeding with vorapaxar added to the standard of care versus the standard of care alone.
The study is also designed to assess risk of bleeding with vorapaxar added to the standard of care versus the standard of care alone.
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Detailed Description
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Conditions
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Atherosclerosis
Ischemia
Myocardial Infarction
Cerebrovascular Accident
Peripheral Arterial Disease
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
TRIPLE
Participants
Investigators
Outcome Assessors
Study Groups
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Placebo
1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
matching tablet daily for at least 1 year
Vorapaxar
one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
Group Type
EXPERIMENTAL
Vorapaxar
Intervention Type
DRUG
2.5-mg tablet daily for at least 1 year
Interventions
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Vorapaxar
2.5-mg tablet daily for at least 1 year
Intervention Type
DRUG
Placebo
matching tablet daily for at least 1 year
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
Men and women at least 18 years old with evidence or a history of atherosclerosis involving the coronary, cerebral, or peripheral vascular systems by one or more of the following:
* history of myocardial infarction (heart attack)
* history of ischemic stroke (stroke due to a blocked artery)
* history of peripheral arterial disease
* history of myocardial infarction (heart attack)
* history of ischemic stroke (stroke due to a blocked artery)
* history of peripheral arterial disease
Exclusion Criteria
* history of intracranial hemorrhage or of central nervous system (CNS) surgery, tumor, or aneurysm
* any bleeding disorder or abnormality
* sustained severe hypertension or valvular heart disease
* current or recent platelet count \<100,000 mm\^3
* planned or ongoing treatment with a blood thinning medication
* pregnancy
* any significant medical or physiological condition or abnormality that could put the subject at increased risk or limit the subject's ability to participate for the duration of the study
* any bleeding disorder or abnormality
* sustained severe hypertension or valvular heart disease
* current or recent platelet count \<100,000 mm\^3
* planned or ongoing treatment with a blood thinning medication
* pregnancy
* any significant medical or physiological condition or abnormality that could put the subject at increased risk or limit the subject's ability to participate for the duration of the study
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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The TIMI Study Group
OTHER
Sponsor Role
collaborator
Merck Sharp & Dohme LLC
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
Reference Type
DERIVED
Berg DD, Freedman BL, Bonaca MP, Jarolim P, Scirica BM, Goodrich EL, Sabatine MS, Morrow DA. Cardiovascular Biomarkers and Heart Failure Risk in Stable Patients With Atherothrombotic Disease: A Nested Biomarker Study From TRA 2 degrees P-TIMI 50. J Am Heart Assoc. 2021 May 4;10(9):e018673. doi: 10.1161/JAHA.120.018673. Epub 2021 Apr 22.
Reference Type
DERIVED
Qamar A, Morrow DA, Creager MA, Scirica BM, Olin JW, Beckman JA, Murphy SA, Bonaca MP. Effect of vorapaxar on cardiovascular and limb outcomes in patients with peripheral artery disease with and without coronary artery disease: Analysis from the TRA 2 degrees P-TIMI 50 trial. Vasc Med. 2020 Apr;25(2):124-132. doi: 10.1177/1358863X19892690. Epub 2020 Jan 30.
Reference Type
DERIVED
Xu H, Bonaca MP, Goodrich E, Scirica BM, Morrow DA. Efficacy and safety of vorapaxar for secondary prevention in low body weight in patients with atherosclerosis: analyses from the TRA 2 degrees P-TIMI 50 Trial. Eur Heart J Acute Cardiovasc Care. 2021 Apr 8;10(2):190-199. doi: 10.1177/2048872619883354. Epub 2019 Oct 23.
Reference Type
DERIVED
Bonaca MP, Creager MA, Olin J, Scirica BM, Gilchrist IC Jr, Murphy SA, Goodrich EL, Braunwald E, Morrow DA. Peripheral Revascularization in Patients With Peripheral Artery Disease With Vorapaxar: Insights From the TRA 2 degrees P-TIMI 50 Trial. JACC Cardiovasc Interv. 2016 Oct 24;9(20):2157-2164. doi: 10.1016/j.jcin.2016.07.034.
Reference Type
DERIVED
Bohula EA, Bonaca MP, Braunwald E, Aylward PE, Corbalan R, De Ferrari GM, He P, Lewis BS, Merlini PA, Murphy SA, Sabatine MS, Scirica BM, Morrow DA. Atherothrombotic Risk Stratification and the Efficacy and Safety of Vorapaxar in Patients With Stable Ischemic Heart Disease and Previous Myocardial Infarction. Circulation. 2016 Jul 26;134(4):304-13. doi: 10.1161/CIRCULATIONAHA.115.019861.
Reference Type
DERIVED
Kidd SK, Bonaca MP, Braunwald E, De Ferrari GM, Lewis BS, Merlini PA, Murphy SA, Scirica BM, White HD, Morrow DA. Universal Classification System Type of Incident Myocardial Infarction in Patients With Stable Atherosclerosis: Observations From Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events (TRA 2 degrees P)-TIMI 50. J Am Heart Assoc. 2016 Jul 18;5(7):e003237. doi: 10.1161/JAHA.116.003237.
Reference Type
DERIVED
Berg DD, Bonaca MP, Braunwald E, Corbalan R, Goto S, Kiss RG, Murphy SA, Scirica BM, Spinar J, Morrow DA. Outcomes in Stable Patients With Previous Atherothrombotic Events Receiving Vorapaxar Who Experience a New Acute Coronary Event (from TRA2 degrees P-TIMI 50). Am J Cardiol. 2016 Apr 1;117(7):1055-8. doi: 10.1016/j.amjcard.2015.12.052. Epub 2016 Jan 14.
Reference Type
DERIVED
Bonaca MP, Gutierrez JA, Creager MA, Scirica BM, Olin J, Murphy SA, Braunwald E, Morrow DA. Acute Limb Ischemia and Outcomes With Vorapaxar in Patients With Peripheral Artery Disease: Results From the Trial to Assess the Effects of Vorapaxar in Preventing Heart Attack and Stroke in Patients With Atherosclerosis-Thrombolysis in Myocardial Infarction 50 (TRA2 degrees P-TIMI 50). Circulation. 2016 Mar 8;133(10):997-1005. doi: 10.1161/CIRCULATIONAHA.115.019355. Epub 2016 Jan 29.
Reference Type
DERIVED
Bohula EA, Aylward PE, Bonaca MP, Corbalan RL, Kiss RG, Murphy SA, Scirica BM, White H, Braunwald E, Morrow DA. Efficacy and Safety of Vorapaxar With and Without a Thienopyridine for Secondary Prevention in Patients With Previous Myocardial Infarction and No History of Stroke or Transient Ischemic Attack: Results from TRA 2 degrees P-TIMI 50. Circulation. 2015 Nov 17;132(20):1871-9. doi: 10.1161/CIRCULATIONAHA.114.015042. Epub 2015 Sep 3.
Reference Type
DERIVED
Magnani G, Bonaca MP, Braunwald E, Dalby AJ, Fox KA, Murphy SA, Nicolau JC, Oude Ophuis T, Scirica BM, Spinar J, Theroux P, Morrow DA. Efficacy and safety of vorapaxar as approved for clinical use in the United States. J Am Heart Assoc. 2015 Mar 19;4(3):e001505. doi: 10.1161/JAHA.114.001505.
Reference Type
DERIVED
Cavender MA, Scirica BM, Bonaca MP, Angiolillo DJ, Dalby AJ, Dellborg M, Morais J, Murphy SA, Ophuis TO, Tendera M, Braunwald E, Morrow DA. Vorapaxar in patients with diabetes mellitus and previous myocardial infarction: findings from the thrombin receptor antagonist in secondary prevention of atherothrombotic ischemic events-TIMI 50 trial. Circulation. 2015 Mar 24;131(12):1047-53. doi: 10.1161/CIRCULATIONAHA.114.013774. Epub 2015 Feb 13.
Reference Type
DERIVED
Bonaca MP, Scirica BM, Braunwald E, Wiviott SD, Goto S, Nilsen DW, Bonarjee V, Murphy SA, Morrow DA. New ischemic stroke and outcomes with vorapaxar versus placebo: results from the TRA 2 degrees P-TIMI 50 trial. J Am Coll Cardiol. 2014 Dec 9;64(22):2318-26. doi: 10.1016/j.jacc.2014.07.997. Epub 2014 Dec 1.
Reference Type
DERIVED
Bonaca MP, Scirica BM, Braunwald E, Wiviott SD, O'Donoghue ML, Murphy SA, Morrow DA. Coronary stent thrombosis with vorapaxar versus placebo: results from the TRA 2 degrees P-TIMI 50 trial. J Am Coll Cardiol. 2014 Dec 9;64(22):2309-17. doi: 10.1016/j.jacc.2014.09.037. Epub 2014 Dec 1.
Reference Type
DERIVED
Bonaca MP, Scirica BM, Creager MA, Olin J, Bounameaux H, Dellborg M, Lamp JM, Murphy SA, Braunwald E, Morrow DA. Vorapaxar in patients with peripheral artery disease: results from TRA2degreesP-TIMI 50. Circulation. 2013 Apr 9;127(14):1522-9, 1529e1-6. doi: 10.1161/CIRCULATIONAHA.112.000679. Epub 2013 Mar 15.
Reference Type
DERIVED
Morrow DA, Alberts MJ, Mohr JP, Ameriso SF, Bonaca MP, Goto S, Hankey GJ, Murphy SA, Scirica BM, Braunwald E; Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events-TIMI 50 Steering Committee and Investigators. Efficacy and safety of vorapaxar in patients with prior ischemic stroke. Stroke. 2013 Mar;44(3):691-8. doi: 10.1161/STROKEAHA.111.000433. Epub 2013 Feb 8.
Reference Type
DERIVED
Scirica BM, Bonaca MP, Braunwald E, De Ferrari GM, Isaza D, Lewis BS, Mehrhof F, Merlini PA, Murphy SA, Sabatine MS, Tendera M, Van de Werf F, Wilcox R, Morrow DA; TRA 2 degrees P-TIMI 50 Steering Committee Investigators. Vorapaxar for secondary prevention of thrombotic events for patients with previous myocardial infarction: a prespecified subgroup analysis of the TRA 2 degrees P-TIMI 50 trial. Lancet. 2012 Oct 13;380(9850):1317-24. doi: 10.1016/S0140-6736(12)61269-0. Epub 2012 Aug 26.
Reference Type
DERIVED
Morrow DA, Braunwald E, Bonaca MP, Ameriso SF, Dalby AJ, Fish MP, Fox KA, Lipka LJ, Liu X, Nicolau JC, Ophuis AJ, Paolasso E, Scirica BM, Spinar J, Theroux P, Wiviott SD, Strony J, Murphy SA; TRA 2P-TIMI 50 Steering Committee and Investigators. Vorapaxar in the secondary prevention of atherothrombotic events. N Engl J Med. 2012 Apr 12;366(15):1404-13. doi: 10.1056/NEJMoa1200933. Epub 2012 Mar 24.
Reference Type
DERIVED
Morrow DA, Scirica BM, Fox KA, Berman G, Strony J, Veltri E, Bonaca MP, Fish P, McCabe CH, Braunwald E; TRA 2(o)P-TIMI 50 Investigators. Evaluation of a novel antiplatelet agent for secondary prevention in patients with a history of atherosclerotic disease: design and rationale for the Thrombin-Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events (TRA 2 degrees P)-TIMI 50 trial. Am Heart J. 2009 Sep;158(3):335-341.e3. doi: 10.1016/j.ahj.2009.06.027.
Reference Type
DERIVED
Study Documents
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Document Type: CSR Synopsis
View DocumentOther Identifiers
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TRA 2°P - TIMI 50
Identifier Type: -
Identifier Source: secondary_id
2006-002942-12
Identifier Type: -
Identifier Source: secondary_id
MK-5348-015
Identifier Type: OTHER
Identifier Source: secondary_id
P04737
Identifier Type: -
Identifier Source: org_study_id
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