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

NCT ID: NCT01280630

Last Updated: 2012-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Coronary Syndrome

Study Design

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Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paurus M Irani, MD

Role: STUDY_DIRECTOR

AZ India

Dr Jamshed Dalal

Role: PRINCIPAL_INVESTIGATOR

Kokila Ben Dhirubhai Ambani Hospital

Dr Keyur Parikh

Role: PRINCIPAL_INVESTIGATOR

Heart Care Hospitals

Dr S S Ramesh

Role: PRINCIPAL_INVESTIGATOR

Bhagwan Mahaveer Jain Hear Centre

Dr Upendra Kaul

Role: PRINCIPAL_INVESTIGATOR

Escorts Hospitals

Locations

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Research Site

Hyderabad, Andhra Pradesh, India

Site Status

Research Site

Ahmedabad, Gujarat, India

Site Status

Research Site

Bangalore, Karnataka, India

Site Status

Research Site

Mumbai, Maharashtra, India

Site Status

Research Site

Pune, Maharashtra, India

Site Status

Research Site

New Delhi, National Capital Territory of Delhi, India

Site Status

Research Site

Chennai, Tamil Nadu, India

Site Status

Countries

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India

Other Identifiers

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NIS-CIN-XXX-2010/1

Identifier Type: -

Identifier Source: org_study_id

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