Phase III Acute Coronary Syndrome (APPRAISE-2) 


Tracking Information

Start Date  ICMJEMarch 2009
Estimated Primary Completion DateNovember 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2009)		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 ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00831441 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: January 28, 2009)
  • 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 ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEPhase III Acute Coronary Syndrome
Official Title  ICMJEApixaban 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
Brief Summary

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

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJEPrevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEAcute Coronary Syndrome
Intervention  ICMJE
  • 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
Study Arms / Comparison Groups
  • Apixaban: Active Comparator
    Intervention: Drug: Apixaban
  • Placebo: Placebo Comparator
    Intervention: Drug: Placebo

Recruitment Information

Recruitment Status  ICMJERecruiting
Estimated Enrollment  ICMJE10848
Estimated Completion DateNovember 2011
Estimated Primary Completion DateNovember 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
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.
Location Countries  ICMJEUnited 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

Administrative Information

NCT ID  ICMJENCT00831441
Responsible PartyStudy Director, Bristol-Myers Squibb
Study ID Numbers  ICMJECV185-068, EUDRACT# 2008-008298-77
Study Sponsor  ICMJEBristol-Myers Squibb
Collaborators  ICMJE
  • Pfizer
  • Duke University
Investigators  ICMJE
Study Director:Bristol-Myers SquibbBristol-Myers Squibb
Information Provided ByBristol-Myers Squibb