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

September 6, 2007
September 26, 2013
September 2007
December 2011   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00526474 on ClinicalTrials.gov Archive Site
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 ]
Not Provided
Not Provided
Not Provided
 
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)
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)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Atherosclerosis
  • Ischemia
  • Myocardial Infarction
  • Cerebrovascular Accident
  • Drug: SCH 530348
    2.5-mg tablet daily for at least 1 year
  • Drug: Placebo
    matching tablet daily for at least 1 year
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: SCH 530348
    Intervention: Drug: SCH 530348

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26449
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00526474
P04737, TRA 2°P - TIMI 50, 2006-002942-12
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
The TIMI Study Group
Not Provided
Merck Sharp & Dohme Corp.
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP