Phase III Acute Coronary Syndrome - Full Text View

Sponsor:	Bristol-Myers Squibb
Collaborators:	Pfizer Duke University
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00831441

Purpose

The purpose of this study is to determine if apixaban is superior to placebo for preventing cardiovascular death, non-fatal myocardial infarction, or ischemic stroke in subjects with a recent acute coronary syndrome

Condition	Intervention	Phase
Acute Coronary Syndrome	Drug: Apixaban Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention
Official Title:	Apixaban for Prevention of Acute Ischemic Events - 2 A Phase 3, Randomized, Double-Blind, Evaluation of the Safety and Efficacy of Apixaban In Subjects With a Recent Acute Coronary Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack

Drug Information available for: Apixaban

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Time to first occurrence of cardiovascular death, myocardial infarction, or ischemic stroke [ Time Frame: At the time of first event ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Unstable angina [ Time Frame: At the time of first event ] [ Designated as safety issue: No ]
Hemorrhagic stroke [ Time Frame: At the time of first event ] [ Designated as safety issue: Yes ]
Fatal bleeding [ Time Frame: At the time of first event ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	10848
Study Start Date:	March 2009
Estimated Study Completion Date:	November 2011
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Apixaban	Drug: Apixaban Tablets, Oral, 5 mg, twice daily, until study end Other Name: BSM-562247
Placebo Comparator: Placebo	Drug: Placebo Tablets, Oral, 0 mg, twice daily, until study end

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Acute coronary syndrome (ACS)
Clinically stable
Receiving standard of care for ACS

Exclusion Criteria:

Severe hypertension
Active bleeding or high risk for major bleeding
Hemoglobin < 9 g/dL

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00831441

Show 1016 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Pfizer

Duke University

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

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

Investigator Inquiry form This link exits the ClinicalTrials.gov site

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

No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Alexander JH, Lopes RD, James S, Kilaru R, He Y, Mohan P, Bhatt DL, Goodman S, Verheugt FW, Flather M, Huber K, Liaw D, Husted SE, Lopez-Sendon J, De Caterina R, Jansky P, Darius H, Vinereanu D, Cornel JH, Cools F, Atar D, Leiva-Pons JL, Keltai M, Ogawa H, Pais P, Parkhomenko A, Ruzyllo W, Diaz R, White H, Ruda M, Geraldes M, Lawrence J, Harrington RA, Wallentin L; APPRAISE-2 Investigators. Apixaban with antiplatelet therapy after acute coronary syndrome. N Engl J Med. 2011 Aug 25;365(8):699-708. Epub 2011 Jul 24.

Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00831441 History of Changes
Other Study ID Numbers:	CV185-068, EUDRACT# 2008-008298-77
Study First Received:	January 28, 2009
Last Updated:	December 2, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

NOS

Additional relevant MeSH terms:

Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris

Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012