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TRACE: Multicentre Retrospective Study to Understand Anti-thrombotic Treatment Patterns and Outcomes of Acute Coronary Syndrome (ACS) Patients

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT01280630
Collaborator
(none)
500
Enrollment
7
Locations
2.9
Duration (Months)
71.4
Patients Per Site
24.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

TRACE is a Multicentre Retrospective Study planned to gather follow up data for a period of 1 year in order to understand anti-thrombotic management patterns and outcomes of Acute Coronary Syndrome patients in India.

This retrospective study is designed to provide a rapid and quick analysis of the existing database of ACS patients. So as to ensure quality check in the study, a pilot study will be conducted with around 500 patients at 10 centres across India and based on the meaningful results of the pilot study, full retrospective multi-centric study will be initiated at various selected centres across India. This study will use available registry data from a defined time period of Jan 2007-Dec 2009.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    500 participants
    Time Perspective:
    Retrospective
    Official Title:
    A Multicentre Retrospective Study to Understand Anti-thrombotic Treatment Patterns and Outcomes of Acute Coronary Syndrome (ACS) Patients in India
    Study Start Date :
    Feb 1, 2011
    Actual Primary Completion Date :
    May 1, 2011
    Actual Study Completion Date :
    May 1, 2011

    Outcome Measures

    Primary Outcome Measures

    1. Anti thrombotic strategies used in ACS patients [Jan 2007-Dec 2009]

    2. Anti-thrombotic treatment strategies in a 'real-life' observational setting across different sites in India. [Jan 2007-Dec 2009]

    Secondary Outcome Measures

    1. ACS outcomes with respect to: -Revascularization -Angina/ Re-infarction -Cardiogenic shock/Heart failure/Cardiac arrest -Atrial fibrillation/flutter -Ventricular Fibrillation/ Sustained V Tachycardia -Stroke -Mortality -Bleeding [Jan 2007-Dec 2009]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients of the age of 18 years or older and hospitalized for ACS within the previous 3 years.

    • Diagnosis of STEMI, NSTEMI or UA using Standard and Universal Definition of Myocardial Infarction

    Exclusion Criteria:

    • UA, STEMI and NSTEMI precipitated by or as a complication of surgery, trauma, or GI bleeding or post-PCI.

    • UA, STEMI and NSTEMI occurring in patients already hospitalized for other reasons

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Hyderabad Andra Pradesh India
    2 Research Site New Delhi Delhi India
    3 Research Site Ahmedabad Gujarat India
    4 Research Site Bangalore Karnataka India
    5 Research Site Mumbai Maharastra India
    6 Research Site Pune Maharastra India
    7 Research Site Chennai Tamil Nadu India

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Study Director: Paurus M Irani, MD, AZ India
    • Principal Investigator: Dr Jamshed Dalal, Kokila Ben Dhirubhai Ambani Hospital
    • Principal Investigator: Dr Keyur Parikh, Heart Care Hospitals
    • Principal Investigator: Dr S S Ramesh, Bhagwan Mahaveer Jain Hear Centre
    • Principal Investigator: Dr Upendra Kaul, Escorts Hospitals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT01280630
    Other Study ID Numbers:
    • NIS-CIN-XXX-2010/1
    First Posted:
    Jan 21, 2011
    Last Update Posted:
    Feb 1, 2012
    Last Verified:
    Jan 1, 2012
    Keywords provided by AstraZeneca
    ACS: Acute coronary syndrome Retrospective Registry
    Additional relevant MeSH terms:
    Acute Coronary Syndrome
    Syndrome

    Study Results

    No Results Posted as of Feb 1, 2012