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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01280630

Acronym

TRACE

Enrollment

500

Registered

2011-01-21

Start date

2011-02-28

Completion date

2011-05-31

Last updated

2012-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

Keywords

ACS: Acute coronary syndrome Retrospective Registry

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.

Interventions

None listed

Study design

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

India

Outcome results