A Phase 3, Randomized, Double-Blind, Evaluation of the Safety and Efficacy of Apixaban In Subjects with a Recent Acute Coronary Syndrome

BristolMyers Squibb37 sites in 1 country1,080 target enrollmentStarted: TBD

Conditions

Trial Snapshot

Phase: Phase 3
Sponsor
Enrollment: 1,080
Locations: 37
Primary Endpoint: 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 ]

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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 syndromehe trial is part of a global trial and where currently recruitment is underway, It is estimated that total of 1080 patients will be recruited from Indian sites. The recruitment in India has started and as on date we have a total of 16 patients enrolled for the study.

Study Design

Masking: Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

Eligibility Criteria

Inclusion Criteria

•Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No CriteriaInclusion Criteria:Acute coronary syndrome (ACS) Clinically stable Receiving standard of care for ACS.

Exclusion Criteria

•Exclusion Criteria:Severe hypertension Active bleeding or high risk for major bleeding Hemoglobin less than 9 g/dL.

Outcomes

Primary Outcomes

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 Outcomes

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 ]

Investigators

Sponsor

BristolMyers Squibb

Sponsor Class

Pharmaceutical industry-Global

Study Sites (37)

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