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. )

First Received on September 7, 2007. Last Updated on October 12, 2011 History of Changes

Sponsor:	Schering-Plough
Collaborator:	Duke University
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00527943

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:

MedlinePlus related topics: Atherosclerosis Coronary Artery Disease 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, 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):

Tricoci P, Huang Z, Held C, Moliterno DJ, Armstrong PW, Van de Werf F, White HD, Aylward PE, Wallentin L, Chen E, Lokhnygina Y, Pei J, Leonardi S, Rorick TL, Kilian AM, Jennings LH, Ambrosio G, Bode C, Cequier A, Cornel JH, Diaz R, Erkan A, Huber K, Hudson MP, Jiang L, Jukema JW, Lewis BS, Lincoff AM, Montalescot G, Nicolau JC, Ogawa H, Pfisterer M, Prieto JC, Ruzyllo W, Sinnaeve PR, Storey RF, Valgimigli M, Whellan DJ, Widimsky P, Strony J, Harrington RA, Mahaffey KW; TRACER Investigators. Thrombin-receptor antagonist vorapaxar in acute coronary syndromes. N Engl J Med. 2012 Jan 5;366(1):20-33. Epub 2011 Nov 13.

TRA*CER Executive and Steering Committees. The Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRA*CER) trial: study design and rationale. Am Heart J. 2009 Sep;158(3):327-334.e4.

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 22, 2012