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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01280630
First received: January 20, 2011
Last updated: January 31, 2012
Last verified: January 2012
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Disease
Heart Diseases
Myocardial Ischemia
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014