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NCT01280630 Clinical Trial

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

Acute Coronary Syndrome Clinical Trial

— TRACE  

Official title:
A Multicentre Retrospective Study to Understand Anti-thrombotic Treatment Patterns and Outcomes of Acute Coronary Syndrome (ACS) Patients in India

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01280630
Other study ID # NIS-CIN-XXX-2010/1
Secondary ID
Status Completed
Phase N/A
First received January 20, 2011
Last updated January 31, 2012
Start date February 2011
Est. completion date May 2011

Study information
Verified date January 2012
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority India: Drugs Controller General of India
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 500
Est. completion date May 2011
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
India Research Site Ahmedabad Gujarat
India Research Site Bangalore Karnataka
India Research Site Chennai Tamil Nadu
India Research Site Hyderabad Andra Pradesh
India Research Site Mumbai Maharastra
India Research Site New Delhi Delhi
India Research Site Pune Maharastra

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary Anti thrombotic strategies used in ACS patients Jan 2007-Dec 2009 No
Primary Anti-thrombotic treatment strategies in a `real-life' observational setting across different sites in India. Jan 2007-Dec 2009 No
Secondary 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 No
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