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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)

This study has been terminated.
(The trial was terminated at the request of the Data and Safety Monitoring Board.)
Sponsor:
Collaborator:
Duke University
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00527943
First received: September 7, 2007
Last updated: October 12, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Atherosclerosis
Myocardial Ischemia
Myocardial Infarction
 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 Acute Coronary Syndrome: Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRA•CER)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Schering-Plough:

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, recurrent ischemia with rehospitalization, 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: 12944
Study Start Date: December 2007
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
oral tablets; matching placebo for SCH 530348 loading and maintenance dosing; once daily for at least 1 year
Experimental: SCH 530348 Drug: SCH 530348
oral tablets; 40-mg loading dose on first day, followed by 2.5 mg once 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 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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided by Schering-Plough

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

Responsible Party: Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00527943     History of Changes
Other Study ID Numbers: P04736, TRA•CER, 2006-002809-31
Study First Received: September 7, 2007
Last Updated: October 12, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Atherosclerosis
Myocardial Ischemia
Coronary Artery Disease
Infarction
Ischemia
Myocardial Infarction
Acute Coronary Syndrome
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
 Cardiovascular Diseases
Heart Diseases
Coronary Disease
Pathologic Processes
Necrosis
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013