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A Study to Evaluate the Safety of Apixaban in Acute Coronary Syndrome (ACS) Japanese Patients

NCT00852397 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2013-08-29

Study results available
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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 combination with standard therapy (aspirin and /or additional antiplatelet therapy) over a 24 week treatment period in selected subjects with recent (≤7 days) acute coronary syndrome.

Conditions

  • Acute Coronary Syndrome

Interventions

DRUG

Apixaban

Apixaban 2.5 mg tablet BID for 24 weeks

DRUG

Apixaban

Apixaban 5.0 mg tablet BID for 24 weeks

OTHER

Placebo

Placebo tablet for 24 weeks

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00852397 on ClinicalTrials.gov