Central India Medical research Ethics Committee, Nagpur
Approved
CHL-Apollo Hospitals ethics commitee, Indore
Submittted/Under Review
EC Avanti Institute of Cardiology, Maharastra
Submittted/Under Review
EC Baroda Heart Institute & Research Centre, Vadodara
Approved
EC Deenanath Mangeshkar Hospital & research center, pune
Approved
EC Dr. Ramesh Cardiac & Multispeciality Hopsital, AP
Approved
EC Escorts Heart Institute, Delhi
Approved
EC for Cardiac Care & Conselling Center, Pune
Approved
EC for MS Ramaih Memorial Hospital, Bangalore
Approved
EC Fortis Hospital, Rajasthan
Submittted/Under Review
Ec Grant Medical Fondation, Pune
Approved
EC Heart & General Hospital, Jaipur
Approved
EC Heart Care Clinica, Ahmedabad
Approved
Ec Holy Family, Mumbai
Submittted/Under Review
EC JSS Medical College & Hospital, Mysore
Submittted/Under Review
EC Lifecare institute of Medical Sciences & Research, Ahmedabad
Approved
EC Monilek Hospital & Research Center, Jaipur
Approved
EC Nanjappa Hospital, Karnataka
Approved
EC Narayana Hrudayalaya, Bangalore
Submittted/Under Review
EC SP Medical College & AG Hospital, Bikaner
Approved
EC TCVS Pvt. Ltd, Ahmedabad
Approved
EC Vikram Hospital & Heart Care, Mysore
Approved
Ethics Committe, Apollo Hospitals
Approved
Ethics committee -Osmania Medical college
Submittted/Under Review
Ethics Committee, Mediciti Hospital
Approved
Institution Ethics Committee, lucknow
Approved
Institutional Ethics Committe, G. Kuppuswamy Naidu Memorial Hospital
Approved
Medanta Independent Ethics commitee, Gurgaon
Submittted/Under Review
Nagpur Independent ethics committee
Submittted/Under Review
Nagpur Independent ethics committee
Submittted/Under Review
Norms Ethical committee, Mangalore
Submittted/Under Review
S.R.Kalla Memorial Ethical Committee for Human Research , 78,Dhuleshwar Garden, Behind HSBC Bank, Sardar Patel Marg, C-Scheme, Jaipur - 302001, India
Approved
St John's medical college and Hospital- Institutional Ethics commitee, Bangalore
Submittted/Under Review
Tagore Heart Care and Research Centre, Banda Bahadur Nagar, Mahavir Marg, Jalandhar - 144008
Approved
The Independent Ethics Committee, New Delhi
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
Acute Coronary Syndrome,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Drug: Apixaban
Tablets, Oral, 5 mg, twice daily, until study end
Comparator Agent
Drug: Placebo
Tablets, Oral, 5 mg, twice daily, until study end
Inclusion Criteria
Age From
Age To
Gender
Details
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
ExclusionCriteria
Details
Exclusion Criteria:
Severe hypertension
Active bleeding or high risk for major bleeding
Hemoglobin less than 9 g/dL
Method of Generating Random Sequence
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome
Outcome
TimePoints
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
Outcome
TimePoints
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 ]
Target Sample Size
Total Sample Size="1080" Sample Size from India="" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 3
Date of First Enrollment (India)
Date Missing
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
06/03/2009
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="3" Months="0" Days="0"
Recruitment Status of Trial (Global)
Open to Recruitment
Recruitment Status of Trial (India)
Publication Details
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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.