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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

January 28, 2009
December 2, 2010
March 2009
November 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00831441 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Phase III Acute Coronary Syndrome
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

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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Acute Coronary Syndrome
  • Drug: Apixaban
    Tablets, Oral, 5 mg, twice daily, until study end
    Other Name: BSM-562247
  • Drug: Placebo
    Tablets, Oral, 0 mg, twice daily, until study end
  • Active Comparator: Apixaban
    Intervention: Drug: Apixaban
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10848
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   China,   Colombia,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Hungary,   India,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   New Zealand,   Norway,   Peru,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Singapore,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   Turkey,   Ukraine,   United Kingdom
 
NCT00831441
CV185-068, EUDRACT# 2008-008298-77
Yes
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
  • Pfizer
  • Duke University
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP