A Clinical Trial to Evaluate the Safety and Efficacy of Apixaban In Subjects with a Recent Acute Coronary Syndrome

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000249

Enrollment

1080

Registered

2009-09-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Drug: Apixaban: Tablets, Oral, 5 mg, twice daily, until study end Control Intervention1: Drug: Placebo: Tablets, Oral, 5 mg, twice daily, until study end

Eligibility

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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 ] Timepoint:	—

Secondary

Measure	Time frame
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 ] Timepoint:	—

Countries

India

Contacts

Public ContactRamkrishnan Sundaram

santosh.jha@bms.com022-66288650

Outcome results