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

NCT01280630 | Completed

• 1 other identifier: NIS-CIN-XXX-2010/1
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 7

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.

Conditions

Acute Coronary Syndrome

Keywords

ACS: Acute coronary syndrome Retrospective Registry

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ACS patients admitted in tertiary care hospitals

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (7)

Research Site

Hyderabad, Andhra Pradesh, India

Location

Research Site

Ahmedabad, Gujarat, India

Location

Research Site

Bangalore, Karnataka, India

Location

Research Site

Mumbai, Maharashtra, India

Location

Research Site

Pune, Maharashtra, India

Location

Research Site

New Delhi, National Capital Territory of Delhi, India

Location

Research Site

Chennai, Tamil Nadu, India

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Paurus M Irani, MD

  AZ India

  STUDY DIRECTOR

• Dr Jamshed Dalal

  Kokila Ben Dhirubhai Ambani Hospital

  PRINCIPAL INVESTIGATOR

• Dr Keyur Parikh

  Heart Care Hospitals

  PRINCIPAL INVESTIGATOR

• Dr S S Ramesh

  Bhagwan Mahaveer Jain Hear Centre

  PRINCIPAL INVESTIGATOR

• Dr Upendra Kaul

  Escorts Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2011
• First Posted: January 21, 2011
• Study Start: February 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: February 1, 2012

Record last verified: 2012-01

Locations

IN (7)