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

Phase 3

• Conditions: Acute Coronary Syndrome

• Registration Number: CTRI/2009/091/000249
• Lead Sponsor: BristolMyers Squibb

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.

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 1080

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.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 ]

Trial Locations

Locations (37)

"Hope Specialty Hospital, 200- W K Road, Meerut ? 250001 Uttar Pradesh, India.; 🇮🇳 India

"Patiala Heart Institute, 2- Jagdish Marg, Patiala-147 001 (Punjab) India; 🇮🇳 India

Apollo Hospitals; 🇮🇳 Nadu,, India

Arneja Heart Institute; 🇮🇳 Nagpur, MAHARASHTRA, India

Avanti Institute of Cardiology, 5- Abhyankar Road, Dhantoli, Nagpur-440012 Maharashtra; 🇮🇳 India

Baroda Heart Institute & Research Centre; 🇮🇳 390007,, India

Cardiac Care & Counseling Center; 🇮🇳 Pune, India

CHL-Apollo Hospitals; 🇮🇳 Indore, MADHYA PRADESH, India

Deenanath Mangeshkar Hospital and research center,; 🇮🇳 Pune, India

Dr Ramesh Cardiac & Multispeciality Hosp. Ltd.,; 🇮🇳 Andhra, India

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"Hope Specialty Hospital, 200- W K Road, Meerut ? 250001 Uttar Pradesh, India.

🇮🇳India

Dr. Tanuraj Sirohi

Principal investigator