Acute Coronary SyndromeTRACENCT01280630
Multicentre Retrospective Study to Understand Anti-thrombotic Treatment Patterns and Outcomes of Acute Coronary Syndrome (ACS) Patients
An observational study of Acute Coronary Syndrome, run by AstraZeneca at 7 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 500 participants
- Where
- 7 sitesIndia
- Study dates
- Feb 2011to May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ACS patients admitted in tertiary care hospitals
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
India7 sites
Research Site
Ahmedabad, Gujarat
Research Site
Bangalore, Karnataka
Research Site
Chennai, Tamil Nadu
Research Site
Hyderabad, Andhra Pradesh
Research Site
Mumbai, Maharashtra
Research Site
New Delhi, National Capital Territory of Delhi
Research Site
Pune, Maharashtra
About this study
Official title: A Multicentre Retrospective Study to Understand Anti-thrombotic Treatment Patterns and Outcomes of Acute Coronary Syndrome (ACS) Patients in India
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
- Medical subject headings
- Acute Coronary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti thrombotic strategies used in ACS patients
Measured: Jan 2007-Dec 2009
Anti-thrombotic treatment strategies in a 'real-life' observational setting across different sites in India.
Measured: 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
Measured: Jan 2007-Dec 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paurus M Irani, MD, Study director, AZ IndiaDr Jamshed Dalal, Principal investigator, Kokila Ben Dhirubhai Ambani HospitalDr Keyur Parikh, Principal investigator, Heart Care HospitalsDr S S Ramesh, Principal investigator, Bhagwan Mahaveer Jain Hear CentreDr Upendra Kaul, Principal investigator, Escorts Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01280630
- Sponsor's protocol ID
- NIS-CIN-XXX-2010/1
- Acronym
- TRACE
- Status last verified
- Jan 2012
- First submitted
- 20 Jan 2011
- Last updated
- 1 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Retrospective Study to Understand Anti-thrombotic Treatment Patterns and Outcomes of Acute Coronary Syndrome (ACS) Patients in India
- ClinicalTrials.gov ID
- NCT01280630
- Acronym / sponsor ID
- TRACE / NIS-CIN-XXX-2010/1
- Conditions
- Acute Coronary Syndrome
- Keywords
- ACS: Acute coronary syndrome Retrospective Registry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 21 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ACS patients admitted in tertiary care hospitals
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anti thrombotic strategies used in ACS patients
Time frame: Jan 2007-Dec 2009
Anti-thrombotic treatment strategies in a 'real-life' observational setting across different sites in India.
Time frame: Jan 2007-Dec 2009
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paurus M Irani, MD study director
AZ India
Dr Jamshed Dalal principal investigator
Kokila Ben Dhirubhai Ambani Hospital
Dr Keyur Parikh principal investigator
Heart Care Hospitals
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by AstraZeneca at 7 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti thrombotic strategies used in ACS patients (time frame: Jan 2007-Dec 2009). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2012.