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) - Full Text View

Sponsor:	Schering-Plough
Collaborator:	The TIMI Study Group
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00526474

Purpose

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.

Condition	Intervention	Phase
Atherosclerosis Ischemia Myocardial Infarction Cerebrovascular Accident	Drug: SCH 530348 Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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 a History of Atherosclerotic Disease: Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events (TRA 2°P - TIMI 50)

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack

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, 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:	26450
Study Start Date:	September 2007
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo: Placebo Comparator	Drug: Placebo matching tablet daily for at least 1 year
SCH 530348: Experimental	Drug: SCH 530348 2.5-mg tablet 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 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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided by Schering-Plough

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P04737, TRA 2°P - TIMI 50, 2006-002942-12
Study First Received:	September 6, 2007
Last Updated:	February 4, 2010
ClinicalTrials.gov Identifier:	NCT00526474 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Atherosclerosis
Arterial Occlusive Diseases
Heart Diseases
Cerebral Infarction
Myocardial Ischemia
Nervous System Diseases
Stroke
Vascular Diseases
Central Nervous System Diseases
Ischemia

Arteriosclerosis
Brain Diseases
Cerebrovascular Disorders
Necrosis
Pathologic Processes
Brain Ischemia
Cardiovascular Diseases
Brain Infarction
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on February 08, 2010