To provide long term data from clinical practices in treatment of Myocardial Infarction patients with stable coronary artery disease.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2013/08/003931
• Date of registration: 29-08-2013
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca AB
• Public title: To provide long term data from clinical practices in treatment of Myocardial Infarction patients with stable coronary artery disease.
• Scientific title: Long-Term rIsk, clinical management and healthcare Resource utilization of stable coronary artery diSease in post myocardial infarction patients. - TIGRIS
• Date of first enrolment: 02-09-2013
• Target sample size: 10170
• Recruitment status: Closed to Recruitment of Participants
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=7259
• Study type: Observational
• Study design: Other; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Case Record Numbers Blinding and masking:Not Applicable
• Phase: N/A

Countries of recruitment

Argentina, Australia, Belgium, Brazil, Canada, China, Colombia, Denmark, Finland, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Romania, Spain, Turkey, United Kingdom, United States of America, Venezuela (Bolivarian Republic of)

Contacts

• Name: Virendra Shukla
• Affiliation: Clinical Research Associate

• Name: Virendra Shukla
• Affiliation: Clinical Research Associate

Key inclusion & exclusion criteria

Inclusion criteria: The subject population that will be observed in the NIS must fulfil all of the following criteria:

1.

Provision of subject informed consent

2.

Female and/or male aged 50 years and over

3.

Documented history of presumed spontaneous MI (excluding known peri-procedural or definite secondary MI [eg, due to profound hypotension, hypertensive emergency, tachycardia, or profound anemia]) with their most recent MI occurring 1 to 3 years prior to enrollment and have at least 1 of the following risk factors:

Age . 65 years

. Diabetes mellitus requiring medication

. Documented history of a second prior presumed spontaneous MI ( >1 year ago)

. Documented history of angiographic evidence of multivessel coronary artery disease (CAD)

. Chronic, non-end stage renal dysfunction (15 mL/min . creatinine clearance, calculated by Cockcroft Gault equation, <60 mL/min)
Exclusion criteria: Patients will not be eligible to participate if any of the following exclusion criteria are present:

1.

Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language where interpreter services are not reliably available, psychiatric disturbances, alcohol or drug abuse).

2.

Presence of serious/severe co-morbidities in the opinion of the investigator which may limit life expectancy ( <1 year).

3.

Current participation in a blinded randomized clinical trial.

4.

Patients receiving treatment of ticagrelor beyond 12 months or off label use of ticagrelor.

Age minimum:
Age maximum:
Gender:

Primary Outcome(s)

To describe prospectively and longitudinally in a â??real worldâ?? patient population with a history of MI 1-3 years ago and high risk of developing atherothrombotic events at study entry:

Event rates (time to first occurrence of any event from the composite of MI, unstable angina with urgent revascularization, stroke or death for any cause) in a three-year follow-up period.

2. Healthcare resource utilization associated with these events in a three-year follow-up period.Timepoint: Outcome will be analysed intermittently after 1st year completion of the subject enrolled till Nov 2013 in Dec 2014, later in Dec 2015 for two year and for 3 year follow up data in Dec 2016 and over all analysis will be done in Dec 2017.

Secondary Outcome(s)

1. To describe the rate of ischemic events (MI, unstable angina with urgent revascularization, ischemic stroke, CV death or death with unknown reason) in a three-year follow-up period.

2. To describe the rate of bleeding events requiring medical attention.Timepoint: Outcome will be analysed intermittently after 1st year completion of the subject enrolled till Nov 2013 in Dec 2014, later in Dec 2015 for two year and for 3 year follow up data in Dec 2016 and over all analysis will be done in Dec 2017.

Secondary ID(s)

NCT01866904

Source(s) of Monetary Support

AstraZeneca AB SE- 151 85 Sodertalje Sweden

Ethics review

Status: Approved
Approval date: 10/07/2013
Contact:

IEC, Westfort Hi - Tech Hospital

Status: Approved
Approval date: 25/07/2013
Contact:

Institutional Ethics Committee Fortis Escort Hospital Jaipur

Status: Approved
Approval date: 29/07/2013
Contact:

IEC, Madras Medical Mission, 4 A, Dr J Jayalalitha Nagar, Mogappair, Chennai - 600037

Status: Approved
Approval date: 30/07/2013
Contact:

IEC, Choithram Hospital and Research Centre

Status: Approved
Approval date: 30/07/2013
Contact:

The IEC Fortis Escorts Heart Institute, Room No. 23A, II floor, Residential Tower, Fortis Escorts Heart Institute, Okhla Road, NewDelhi-110025

Status: Approved
Approval date: 31/07/2013
Contact:

Ethics Committee, Apollo Health City

Status: Approved
Approval date: 05/08/2013
Contact:

BM Birla Heart & Research Centre- IEC

Status: Approved
Approval date: 23/08/2013
Contact:

Fortis Hospital Institutional Ethics Committee

Status: Approved
Approval date: 27/08/2013
Contact:

Ethics Committee Sir Ganga Ram Hospital

Status: Approved
Approval date: 30/08/2013
Contact:

Poona Medical Research Foundation, IEC

Status: Approved
Approval date: 02/09/2013
Contact:

IEC , Meenakshi Mission Hospital and Research Centre, Lake Area, Melur Road, Madurai - 625107

Status: Approved
Approval date: 19/09/2013
Contact:

Medisys Clinical Research India Pvt Ltd.

Status: Approved
Approval date: 03/10/2013
Contact:

IEC Fortis Hospital Sector - 62, Phase - 8 Mohali - 160062

Status: Approved
Approval date: 18/10/2013
Contact:

Ethics Committee, PRS Hospital, Killipalam, Karamana, Trivandrum -695002

Status: Approved
Approval date: 14/11/2013
Contact:

MAMC & Associated LNJP, GB Pant Hospital, Gurunanak Eye Centr, IEC, New Delhi - 110002

Status: Approved
Approval date: 29/11/2013
Contact:

Nirmal Hospital Pvt Ltd. Ethics Committee, Ring Road Surat - 395002