Trial to Assess the Effects of Vorapaxar (SCH 530348; MK-5348) in Preventing Heart Attack and Stroke in Particpants With Acute Coronary Syndrome (TRA•CER) (Study P04736)

Last updated: August 22, 2018
Sponsor: Merck Sharp & Dohme Corp.
Overall Status: Terminated

Phase

3

Condition

Myocardial Ischemia

Congestive Heart Failure

Circulation Disorders

Treatment

N/A

Clinical Study ID

NCT00527943
P04736
MK-5348-014
2006-002809-31
TRA•CER
  • Ages > 18
  • All Genders

Study Summary

The study is designed to determine whether vorapaxar, when added to the existing standard of care (eg, aspirin, clopidogrel) for preventing heart attack and stroke in patients with acute coronary syndrome, will yield additional benefit over the existing standard of care 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

Inclusion Criteria: Men and women at least 18 years old with current clinical manifestation ofnon-ST-segment-elevation myocardial infarction (heart attack) according to the followingthree criteria:

  • current symptoms of cardiac ischemia (chest pain leading to cardiac ischemia or heartattack) AND

  • either of the following:

  • concurrent elevation of troponin I or T, or of creatine kinase - myocardial band (CK-MB) to a level above the upper limit of normal, OR

  • concurrent appropriate electrocardiographic evidence AND

  • any one (or more) of the following:

  • age >= 55 years

  • documented history of prior heart attack or coronary revascularization (eg,angioplasty [PCI], coronary artery replacement [CABG])

  • diabetes (documented use of insulin or oral hypoglycemic[s])

  • documented history of peripheral arterial disease

Exclusion

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 thesubject at increased risk or limit the subject's ability to participate for theduration of the study

Study Design

Total Participants: 12944
Study Start date:
December 01, 2007
Estimated Completion Date:
July 01, 2011