Trial to Assess the Effects of SCH 530348 in Preventing Heart Attack and Stroke in Patients With Acute Coronary Syndrome (TRA•CER) (Study P04736AM3)

This study has been terminated.
(The trial was terminated at the request of the Data and Safety Monitoring Board.)
Sponsor:
Collaborator:
Duke Clinical Research Institute
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00527943
First received: September 7, 2007
Last updated: October 18, 2013
Last verified: October 2013

September 7, 2007
October 18, 2013
December 2007
July 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, recurrent ischemia with rehospitalization, 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 NCT00527943 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 ]
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Trial to Assess the Effects of SCH 530348 in Preventing Heart Attack and Stroke in Patients With Acute Coronary Syndrome (TRA•CER) (Study P04736AM3)
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 Acute Coronary Syndrome: Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRA•CER)

The study is designed to determine whether SCH 530348, 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 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
  • Myocardial Ischemia
  • Myocardial Infarction
  • Drug: SCH 530348
    oral tablets; 40-mg loading dose on first day, followed by 2.5 mg once daily for at least 1 year
  • Drug: Placebo
    oral tablets; matching placebo for SCH 530348 loading and maintenance dosing; once 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.
 
Terminated
12944
July 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

Men and women at least 18 years old with current clinical manifestation of non-ST-segment-elevation myocardial infarction (heart attack) according to the following three criteria:

  • current symptoms of cardiac ischemia (chest pain leading to cardiac ischemia or heart attack)

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 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
 
NCT00527943
P04736, TRA•CER, 2006-002809-31
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Duke Clinical Research Institute
Not Provided
Merck Sharp & Dohme Corp.
October 2013

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