Status:
TERMINATED
A Study to Evaluate the Safety of Apixaban in Acute Coronary Syndrome (ACS) Japanese Patients
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the bleeding safety (the composite endpoint of major and clinically relevant non-major bleeding) of 2 doses of apixaban (2.5 mg BID and 5.0 mg BID) or placebo in...
Detailed Description
Due to withdraw of global phase 3 study (APPRAISE-2) for safety issue, B0661004 Data monitoring committee (DMC) also recommended terminating this study. Therefore, Pfizer decided to stop this study.
Eligibility Criteria
Inclusion
- Recent (≤ 7 days) ACS
- Clinically stable, and receiving standard treatment (patients must be treated with aspirin ≤ 100 mg/day, with or without clopidogrel 75 mg/day or ticlopidine 200 mg/day) based on the physician's judgment)
Exclusion
- Scheduled/planned cardiac catheterization, PCI, CABG or other invasive procedure planned in the 24 weeks (within treatment period) following randomization
- Persistent severe hypertension, defined as systolic blood pressure of ≥180 mm Hg or diastolic pressure of ≥110 mm Hg
- Active bleeding or at high risk for bleeding (e.g., cirrhosis of the liver, any history of intracranial hemorrhage).
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT00852397
Start Date
April 1 2009
End Date
December 1 2010
Last Update
August 29 2013
Active Locations (18)
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1
Pfizer Investigational Site
Kasuga, Fukuoka, Japan
2
Pfizer Investigational Site
Kitakyushu, Fukuoka, Japan
3
Pfizer Investigational Site
Gifu, Gifu, Japan
4
Pfizer Investigational Site
Hiroshima, Hiroshima, Japan