Long-Term rIsk, Clinical manaGement and Healthcare Resource Utilization of Stable CAD in Post MI Patients

Terminated

• Conditions: Stable Coronary Artery Disease (CAD), Myocardial Infarction

• Registration Number: NCT01866904
• Lead Sponsor: AstraZeneca

Brief Summary

THis study is intended to provide contemporary data on the burden of disease in patients 1 to 3 years post-MI, including a description of patient characteristics, current treatment patterns, rate of major CV events, and healthcare resource utilization in a 'real world' patient population at high atherothrombotic risk.

Detailed Description

TIGRIS is a multinational, multi-centre, observational, prospective, longitudinal cohort study which will include stable CAD patients with history of MI 1-3 years ago and high risk of developing atherothrombotic events in a real world setting. The follow-up period is 3 years.

Patients will undergo clinical assessments and receive standard medical care as determined by the treating physician. Patients will not receive experimental intervention or experimental treatment as a consequence of their participation in the study.

Study Timeline

• Study First Submitted: 2013-05-29
• Study First Submitted QC: 2013-05-31
• Study First Posted: 2013-06-03
• Study Start: 2013-06-19
• Primary Completion: 2017-03-31
• Study Completion: 2017-03-31
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-30
• Last Update Posted: 2018-09-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9284

Inclusion Criteria

• Stable CAD patients aged 50 years or older with documented history of presumed spontaneous MI 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; chronic renal dysfunction.

Exclusion Criteria

• Presence of serious co-morbidities in the opinion of the investigator which may limit life expectancy (<1 year)
• Current participation in a blinded randomized clinical trial.
• Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient
• Patients receiving treatment of ticagrelor beyond 12 months, or off label use of ticagrelor.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MI, unstable angina with urgent revascularization, stroke, and death for any cause	in a 3-year follow-up period	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.
Healthcare resource utilization	in a 3-year follow-up period	Healthcare resource utilization associated with the events (MI, unstable angina with urgent revascularization, stroke or death for any cause) in a three-year follow-up period.

Secondary Outcome Measures

Name	Time	Method
Bleeding events which require medical attention	in a 3 year follow-up period	To describe the rate of bleeding events requiring medical attention.
Ischemic events (MI, unstable angina with urgent revascularization, ischemic stroke, CV death or death with unknown reason)	in a 3-year follow-up period	To describe the rate of ischemic events (time to first occurrence of any event from the composite of MI, unstable angina with urgent revascularization, ischemic stroke, CV death or death with unknown reason) in a three-year follow-up period.

Trial Locations

Locations (1)

Research Site; 🇻🇪 Caracas, Miranda, Venezuela