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

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ClinicalTrials.gov Identifier: NCT01280630
Recruitment Status : Completed
First Posted : January 21, 2011
Last Update Posted : February 1, 2012
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease
Acute Coronary Syndrome

Study Type : Observational
Actual Enrollment : 500 participants
Time Perspective: Retrospective
Official Title: A Multicentre Retrospective Study to Understand Anti-thrombotic Treatment Patterns and Outcomes of Acute Coronary Syndrome (ACS) Patients in India
Study Start Date : February 2011
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011



Primary Outcome Measures :
  1. Anti thrombotic strategies used in ACS patients [ Time Frame: Jan 2007-Dec 2009 ]
  2. Anti-thrombotic treatment strategies in a `real-life' observational setting across different sites in India. [ Time Frame: Jan 2007-Dec 2009 ]

Secondary Outcome Measures :
  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 [ Time Frame: Jan 2007-Dec 2009 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ACS patients admitted in tertiary care hospitals
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01280630


Locations
India
Research Site
Hyderabad, Andra Pradesh, India
Research Site
New Delhi, Delhi, India
Research Site
Ahmedabad, Gujarat, India
Research Site
Bangalore, Karnataka, India
Research Site
Mumbai, Maharastra, India
Research Site
Pune, Maharastra, India
Research Site
Chennai, Tamil Nadu, India
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Paurus M Irani, MD AZ India
Principal Investigator: 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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01280630     History of Changes
Other Study ID Numbers: NIS-CIN-XXX-2010/1
First Posted: January 21, 2011    Key Record Dates
Last Update Posted: February 1, 2012
Last Verified: January 2012

Keywords provided by AstraZeneca:
ACS: Acute coronary syndrome Retrospective Registry

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases