Safety Study of Apixaban in Recent Acute Coronary Syndrome - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00313300

Purpose

The purpose of this clinical research study is to determine whether apixaban will be safe in people who have recently had unstable angina or a heart attack.

Condition	Intervention	Phase
Acute Coronary Syndrome (ACS)	Drug: Apixaban Drug: Placebo	Phase II

MedlinePlus related topics: Heart Attack

Drug Information available for: Apixaban

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
Official Title:	A Phase 2, Placebo-Controlled, Randomized, Double Blind, Parallel Arm, Dose Ranging Study to Evaluate Safety and Efficacy of Apixaban in Patients With a Recent Acute Coronary Syndrome.

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Major and clinically relevant non-major bleeding [ Time Frame: through end of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Composite of death, non-fatal myocardial infarction, severe recurrent ischemia and non-hemorrhagic stroke. [ Time Frame: through end of treatment ] [ Designated as safety issue: No ]
All bleeding events [ Time Frame: through end of treatment ] [ Designated as safety issue: Yes ]

Enrollment:	1715
Study Start Date:	May 2006
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A1: Active Comparator	Drug: Apixaban Tablets, Oral, 2.5 mg, twice daily, 26 weeks
A2: Experimental	Drug: Apixaban Tablets, Oral, 10 mg, once daily, 26 weeks
A3: Placebo Comparator	Drug: Placebo Tablets, Oral, 0, twice daily, 26 weeks

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Recent (< = 7 days) Acute Coronary Syndrome (ACS).
Clinically stable on optimal treatment

Exclusion Criteria:

High bleeding risk.
Ongoing anticoagulant use.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00313300

Show 152 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CV185-023
Study First Received:	April 10, 2006
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00313300
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Heart Diseases
Myocardial Ischemia
Acute Coronary Syndrome
Vascular Diseases
Ischemia

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009