Multicentre Retrospective Study to Understand Anti-thrombotic Treatment Patterns and Outcomes of Acute Coronary Syndrome (ACS) Patients (TRACE)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01280630
First received: January 20, 2011
Last updated: January 31, 2012
Last verified: January 2012
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Purpose
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 |
|---|
|
Acute Coronary Syndrome |
| Study Type: | Observational |
| Study Design: | 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 |
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Anti thrombotic strategies used in ACS patients [ Time Frame: Jan 2007-Dec 2009 ] [ Designated as safety issue: No ]
- Anti-thrombotic treatment strategies in a `real-life' observational setting across different sites in India. [ Time Frame: Jan 2007-Dec 2009 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 500 |
| Study Start Date: | February 2011 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01280630 History of Changes |
| Other Study ID Numbers: | NIS-CIN-XXX-2010/1 |
| Study First Received: | January 20, 2011 |
| Last Updated: | January 31, 2012 |
| Health Authority: | India: Drugs Controller General of India |
Keywords provided by AstraZeneca:
|
ACS: Acute coronary syndrome Retrospective Registry |
Additional relevant MeSH terms:
|
Acute Coronary Syndrome Myocardial Ischemia Heart Diseases Cardiovascular Diseases Angina Pectoris |
Vascular Diseases Chest Pain Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013