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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)
This study is ongoing, but not recruiting participants.
Study NCT00526474   Information provided by Schering-Plough
First Received: September 6, 2007   Last Updated: November 16, 2009   History of Changes

September 6, 2007
November 16, 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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
26450
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 information is only displayed when the study is recruiting subjects
 
 
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
November 2009

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