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Phase III Acute Coronary Syndrome (APPRAISE-2)

This study has been terminated.
Sponsor:
Collaborators:
Pfizer
Duke University
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00831441
First received: January 28, 2009
Last updated: December 2, 2010
Last verified: November 2010
History of Changes
  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 3

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 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):

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 June 13, 2013