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) - Tabular View

Tracking Information
First Received Date ^ICMJE	September 6, 2007
Last Updated Date	November 16, 2009
Start Date ^ICMJE	September 2007
Estimated Primary Completion Date	September 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 20, 2007)	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 ]
Original Primary Outcome Measures ^ICMJE (submitted: September 24, 2007)	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. ]
Change History	Complete list of historical versions of study NCT00526474 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 20, 2007)	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 ]
Original Secondary Outcome Measures ^ICMJE (submitted: September 24, 2007)	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. ]

Descriptive Information
Brief Title ^ICMJE	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)
Official Title ^ICMJE	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)
Brief Summary	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.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Atherosclerosis Ischemia Myocardial Infarction Cerebrovascular Accident
Intervention ^ICMJE	Drug: SCH 530348 Drug: Placebo
Study Arms / Comparison Groups
Publications *	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.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	26450
Estimated Completion Date	September 2010
Estimated Primary Completion Date	September 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00526474
Responsible Party	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Study ID Numbers ^ICMJE	P04737, TRA 2°P - TIMI 50, 2006-002942-12
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE	The TIMI Study Group
Investigators ^ICMJE
Information Provided By	Schering-Plough
Verification Date	November 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP