Trial to Assess the Effects of SCH 530348 in Preventing Heart Attack and Stroke in Patients With Atherosclerosis (TRA 2°P - TIMI 50) (Study P04737AM3)

This study has been completed.
Sponsor:
Collaborator:
The TIMI Study Group
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00526474
First received: September 6, 2007
Last updated: September 26, 2013
Last verified: September 2013
  Purpose

The study is designed to determine whether SCH 530348, when added to the existing standard of care for preventing heart attack and stroke (eg, aspirin, clopidogrel) in patients with a known history of atherosclerosis, will yield additional benefit over the existing standard of care without SCH 530348 in preventing heart attack and stroke.

The study is also designed to assess risk of bleeding with SCH 530348 added to the standard of care versus the standard of care alone.


Condition Intervention Phase
Atherosclerosis
Ischemia
Myocardial Infarction
Cerebrovascular Accident
Drug: SCH 530348
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • The primary efficacy endpoint of the study is the first occurrence of any component of the composite of cardiovascular death, MI, stroke, and urgent coronary revascularization. [ Time Frame: Through the end of the study. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The key secondary efficacy endpoint is the first occurrence of any component of the composite of cardiovascular death, MI, and stroke. [ Time Frame: Through the end of the study. ] [ Designated as safety issue: No ]

Enrollment: 26449
Study Start Date: September 2007
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
matching tablet daily for at least 1 year
Experimental: SCH 530348 Drug: SCH 530348
2.5-mg tablet daily for at least 1 year

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 CNS surgery, tumor, or aneurysm
  • any bleeding disorder or abnormality
  • sustained severe hypertension or valvular heart disease
  • current or recent platelet count <100,000/cumm
  • 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
No Contacts or Locations Provided
  More Information

No publications provided by Merck Sharp & Dohme Corp.

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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00526474     History of Changes
Other Study ID Numbers: P04737, TRA 2°P - TIMI 50, 2006-002942-12
Study First Received: September 6, 2007
Last Updated: September 26, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Atherosclerosis
Infarction
Ischemia
Myocardial Infarction
Cerebral Infarction
Stroke
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014