Phase 3
N=26,449
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)
Atherosclerosis · Ischemia · Myocardial Infarction · Cerebrovascular Accident · Peripheral Arterial Disease
Bottom Line
View on ClinicalTrials.gov: NCT00526474 ↗Enrolled (actual)
26,449
Serious AEs
26.3%
Results posted
Jun 2014
Primary outcome: Primary: 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 — 12.4; 11.2 Percentage of Participants — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Vorapaxar (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
12.4; 11.2 | 0.001 sig |
| SECONDARY Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, or Stroke Within 3 Years From Randomization |
9.5; 7.9 | <0.001 sig |
| SECONDARY 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 |
2.9; 4.2 | <0.001 sig |
| SECONDARY Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Clinically Significant Bleeding Within 3 Years From Randomization |
11.1; 15.2 | <0.001 sig |
| SECONDARY Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Death From Any Cause, MI, Stroke, or UCR Within 3 Years From Randomization |
13.5; 11.9 | <0.001 sig |
| SECONDARY Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death or an MI Within 3 Years From Randomization |
8.3; 7.2 | <0.001 sig |
| SECONDARY 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 |
14.7; 13.1 | <0.001 sig |
| SECONDARY 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 |
22.5; 20.1 | <0.001 sig |
| SECONDARY Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, Any Revascularization, or UH-VCIN Within 3 Years From Randomization |
21.8; 19.3 | <0.001 sig |
| SECONDARY Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death Within 3 Years From Randomization |
2.8; 2.4 | 0.108 |
| SECONDARY Kaplan-Meier Estimate of the Percentage of Participants Who Experienced an MI Within 3 Years From Randomization |
6.4; 5.4 | 0.002 sig |
| SECONDARY Kaplan-Meier Estimate of the Percentage of Participants Who Experienced UCR Within 3 Years From Randomization |
3.0; 2.8 | 0.127 |
| SECONDARY Kaplan-Meier Estimate of the Percentage of Participants Who Experienced a Stroke Within 3 Years From Randomization |
1.6; 1.2 | 0.002 sig |
| SECONDARY Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause Within 3 Years From Randomization |
4.8; 4.5 | 0.249 |
| SECONDARY Kaplan-Meier Estimate of the Percentage of Participants Who Had a UH-VCIN Within 3 Years From Randomization |
5.6; 4.9 | 0.019 sig |
| SECONDARY Kaplan-Meier Estimate of the Percentage of Participants Who Had Any Revascularization Performed Within 3 Years From Randomization |
16.6; 14.7 | 0.003 sig |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00526474). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.