Clinical trial NCT01280630: Multicentre Retrospective Study to Understand Anti-thrombotic Treatment Patterns and Outcomes of Acute Coronary Syndrome (ACS) Patients
Official title: A Multicentre Retrospective Study to Understand Anti-thrombotic Treatment Patterns and Outcomes of Acute Coronary Syndrome (ACS) Patients in India
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Keywords: ACS: Acute coronary syndrome Retrospective Registry
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-01-21
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ACS patients admitted in tertiary care hospitals

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.


Eligibility criteria: 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

Primary outcomes:
measure: Anti thrombotic strategies used in ACS patients
timeFrame: Jan 2007-Dec 2009
measure: Anti-thrombotic treatment strategies in a 'real-life' observational setting across different sites in India.
timeFrame: Jan 2007-Dec 2009
Secondary outcomes:
measure: 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
timeFrame: Jan 2007-Dec 2009
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Research Site
state: Andra Pradesh
city: New Delhi
country: India
facility: Research Site
state: Delhi
city: Ahmedabad
country: India
facility: Research Site
state: Gujarat
city: Bangalore
country: India
facility: Research Site
state: Karnataka
city: Mumbai
country: India
facility: Research Site
state: Maharastra
city: Pune
country: India
facility: Research Site
state: Maharastra
city: Chennai
country: India
facility: Research Site
state: Tamil Nadu
Study officials:
affiliation: AZ India
name: Paurus M Irani, MD
role: STUDY_DIRECTOR
affiliation: Kokila Ben Dhirubhai Ambani Hospital
name: Dr Jamshed Dalal
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Care Hospitals
name: Dr Keyur Parikh
role: PRINCIPAL_INVESTIGATOR
affiliation: Bhagwan Mahaveer Jain Hear Centre
name: Dr S S Ramesh
role: PRINCIPAL_INVESTIGATOR
affiliation: Escorts Hospitals
name: Dr Upendra Kaul
role: PRINCIPAL_INVESTIGATOR
References: