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)

• ClinicalTrials.gov Identifier: NCT00526474
• Recruitment Status: Completed
• First Posted: September 10, 2007
• Results First Posted: June 18, 2014
• Last Update Posted: September 21, 2018
• Sponsor: Merck Sharp & Dohme LLC
• Collaborator: The Thrombolysis in Myocardial Infarction Study (TIMI) Group
• Information provided by (Responsible Party): Merck Sharp & Dohme LLC

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Atherosclerosis; Ischemia; Myocardial Infarction; Cerebrovascular Accident; Peripheral Arterial Disease	Drug: Vorapaxar; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 26449 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SCH 530348 in Addition to Standard of Care in Subjects With a History of Atherosclerotic Disease: Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events (TRA 2°P - TIMI 50)
• Actual Study Start Date: September 1, 2007
• Actual Primary Completion Date: December 1, 2011
• Actual Study Completion Date: December 1, 2011

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: 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.	Drug: Placebo; matching tablet daily for at least 1 year
Experimental: 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.	Drug: Vorapaxar; 2.5-mg tablet daily for at least 1 year

Outcome Measures

Primary Outcome Measures :

1. Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, or Urgent Coronary Revascularization (UCR) Within 3 Years From Randomization [ Time Frame: up to 3 years ]
   The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, or UCR. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, or UCR within 3 years from randomization.

Secondary Outcome Measures :

1. Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, or Stroke Within 3 Years From Randomization [ Time Frame: up to 3 years ]
   The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, or stroke. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, or stroke within 3 years from randomization.
2. Kaplan-Meier Estimate of the Percentage of Participants Who Met Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) Moderate or Severe Bleeding Criteria Within 3 Years From Randomization [ Time Frame: up to 3 years ]
   Adverse events were categorized as "bleeding events" if the intensity, frequency, or type of the event was other or more than would be normally expected in the given situation (eg, mild nosebleed in a person who does not normally have nosebleeds, greater bruising than expected for a given injury, greater volume of blood loss than expected for a given procedure). The investigator graded the intensity of bleeding events according to the GUSTO cooperative group criteria as follows: Mild , Moderate or Severe and the grading was adjudicated by the CEC. The Kaplan-Meier estimate reports the percentage of participants who experienced GUSTO moderate or severe bleeding within 3 years from randomization.
3. Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Clinically Significant Bleeding Within 3 Years From Randomization [ Time Frame: up to 3 years ]
   Adverse events were categorized as "bleeding events" if the intensity, frequency, or type of the event was other or more than would be normally expected in the given situation (eg, mild nosebleed in a person who does not normally have nosebleeds, greater bruising than expected for a given injury, greater volume of blood loss than expected for a given procedure). The investigator graded the intensity of bleeding events according to the Thrombolysis in Myocardial Infarction (TIMI) Study Group criteria as major, minor or other. "Clinically Significant Bleeding" was defined as the composite of TIMI Major bleeding, TIMI Minor bleeding, or bleeding that required unplanned medical or surgical treatment or unplanned laboratory evaluation even if it did not meet the criteria for TIMI major or minor bleeding. The Kaplan-Meier estimate reports the percentage of participants who experienced clinically significant bleeding within 3 years from randomization.
4. Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Death From Any Cause, MI, Stroke, or UCR Within 3 Years From Randomization [ Time Frame: up to 3 years ]
   The time (in days) from study start to the occurrence of any of the following clinical outcomes was recorded: death from any cause, MI, stroke, or UCR. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced death from any cause, MI, stroke, or UCR within 3 years from randomization.
5. Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death or an MI Within 3 Years From Randomization [ Time Frame: up to 3 years ]
   The time (in days) from study start to the occurrence of CV death or MI. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death or MI within 3 years from randomization.
6. Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, UCR, or Urgent Hospitalization for Vascular Cause of Ischemic Nature (UH-VCIN) Within 3 Years From Randomization [ Time Frame: up to 3 years ]
   The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, UCR or UH-VCIN. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, UCR, or UH-VCIN within 3 years from randomization.
7. Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause, or Experienced an MI, Stroke, or Any Revascularization Within 3 Years From Randomization [ Time Frame: up to 3 years ]
   The time (in days) from study start to death from any cause or the first occurrence of any of the following clinical outcomes was recorded: MI, stroke, or any revascularization procedure . A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who died from any cause, or experienced an MI, stroke, or any revascularization within 3 years from randomization.
8. Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, Any Revascularization, or UH-VCIN Within 3 Years From Randomization [ Time Frame: up to 3 years ]
   The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, any revascularization, or UH-VCIN. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, any revascularization procedure, or UH-VCIN within 3 years from randomization.
9. Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death Within 3 Years From Randomization [ Time Frame: up to 3 years ]
   The time (in days) from study start to CV death (if reported) was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death within 3 years from randomization.
10. Kaplan-Meier Estimate of the Percentage of Participants Who Experienced an MI Within 3 Years From Randomization [ Time Frame: up to 3 years ]
    The time (in days) from study start to the first occurrence of an MI was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced an MI within 3 years from randomization.
11. Kaplan-Meier Estimate of the Percentage of Participants Who Experienced UCR Within 3 Years From Randomization [ Time Frame: up to 3 years ]
    The time (in days) from study start to the first occurrence of UCR was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced UCR within 3 years from randomization.
12. Kaplan-Meier Estimate of the Percentage of Participants Who Experienced a Stroke Within 3 Years From Randomization [ Time Frame: up to 3 years ]
    The time (in days) from study start to first experience of a stroke was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced a stroke within 3 years from randomization.
13. Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause Within 3 Years From Randomization [ Time Frame: up to 3 years ]
    The time (in days) from study start to death from any cause was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who died from any cause within 3 years from randomization.
14. Kaplan-Meier Estimate of the Percentage of Participants Who Had a UH-VCIN Within 3 Years From Randomization [ Time Frame: up to 3 years ]
    The time (in days) from study start to the first occurrence of an UH-VCIN was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who had a UH-VCIN within 3 years from randomization.
15. Kaplan-Meier Estimate of the Percentage of Participants Who Had Any Revascularization Performed Within 3 Years From Randomization [ Time Frame: up to 3 years ]
    The time (in days) from study start to the first occurrence of a revascularization was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who had any revascularization performed within 3 years from randomization.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

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

Contacts and Locations

Sponsors and Collaborators

Merck Sharp & Dohme LLC

The Thrombolysis in Myocardial Infarction Study (TIMI) Group

Investigators

• Study Director: Medical Director; Merck Sharp & Dohme LLC

More Information

Study Data/Documents: CSR Synopsis 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

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. 2019 Oct 23:2048872619883354. doi: 10.1177/2048872619883354. Online ahead of print.

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. 2019 Oct 23:2048872619883354. doi: 10.1177/2048872619883354. Online ahead of print.

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.

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.

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.

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.

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.

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.

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. Erratum In: J Am Heart Assoc. 2015 Apr;4(4). pii: e000633. doi: 10.1161/JAHA.115.000633.

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.

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.

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.

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.

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.

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.

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.

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.

• Responsible Party: Merck Sharp & Dohme LLC
• ClinicalTrials.gov Identifier: NCT00526474
• Other Study ID Numbers: P04737; TRA 2°P - TIMI 50; 2006-002942-12; MK-5348-015 ( Other Identifier: Merck Study Number )
• First Posted: September 10, 2007
• Results First Posted: June 18, 2014
• Last Update Posted: September 21, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
• URL: http://engagezone.msd.com/ds_documentation.php

Additional relevant MeSH terms:

Stroke; Myocardial Infarction; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vorapaxar; Platelet Aggregation Inhibitors