Phase III Acute Coronary Syndrome - Full Text View

Phase III Acute Coronary Syndrome (APPRAISE-2)

This study is currently recruiting participants.

Verified by Bristol-Myers Squibb, April 2009

First Received: January 28, 2009 Last Updated: September 2, 2009 History of Changes

Sponsors and Collaborators:	Bristol-Myers Squibb 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:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
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
Apixaban: Active Comparator	Drug: Apixaban Tablets, Oral, 5 mg, twice daily, until study end
Placebo: Placebo Comparator	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

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Show 1021 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

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

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

Keywords provided by Bristol-Myers Squibb:

NOS

Study placed in the following topic categories:

Heart Diseases
Myocardial Ischemia
Acute Coronary Syndrome
Vascular Diseases
Ischemia

Additional relevant MeSH terms:

Heart Diseases
Pathologic Processes
Disease
Myocardial Ischemia

Syndrome
Acute Coronary Syndrome
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 03, 2009