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

Completed

• Conditions: Acute Coronary Syndrome

• Registration Number: NCT01280630
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-20
• Study First Submitted QC: 2011-01-20
• Study First Posted: 2011-01-21
• Study Start: 2011-02
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-31
• Last Update Posted: 2012-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anti-thrombotic treatment strategies in a 'real-life' observational setting across different sites in India.	Jan 2007-Dec 2009
Anti thrombotic strategies used in ACS patients	Jan 2007-Dec 2009

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇮🇳 Chennai, Tamil Nadu, India