| September 6, 2007 |
| October 29, 2009 |
| September 2007 |
| September 2010 (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 ] |
| 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. ] |
| 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 ] |
| 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. ] |
| |
| Trial to Assess the Effects of SCH 530348 in Preventing Heart Attack and Stroke in Patients With Atherosclerosis (TRA 2°P - TIMI 50) (Study P04737AM2) |
| 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. |
| |
| Phase III |
| Interventional |
| Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
- Atherosclerosis
- Ischemia
- Myocardial Infarction
- Cerebrovascular Accident
|
- Drug: SCH 530348
- Drug: Placebo
|
| |
| Morrow DA, Scirica BM, Fox KA, Berman G, Strony J, Veltri E, Bonaca MP, Fish P, McCabe CH, Braunwald E; TRA 2(o)P-TIMI 50 Investigators. Evaluation of a novel antiplatelet agent for secondary prevention in patients with a history of atherosclerotic disease: design and rationale for the Thrombin-Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events (TRA 2 degrees P)-TIMI 50 trial. Am Heart J. 2009 Sep;158(3):335-341.e3. |
| |
| Recruiting |
| 25000 |
| September 2010 |
| September 2010 (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: SP Clinical Trial Registry Call Center |
1-888-772-8734 |
|
|
|
| United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Singapore, South Africa, Spain, Sweden, Switzerland, United Kingdom |
| |
| NCT00526474 |
| Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| P04737, TRA 2°P - TIMI 50, 2006-002942-12 |
| Schering-Plough |
| The TIMI Study Group |
|
| Schering-Plough |
| October 2009 |
