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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on October 16, 2014