TIGRIS: Long-Term rIsk, Clinical manaGement and Healthcare Resource Utilization of Stable Coronary Artery dISease in Post Myocardial Infarction Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- AstraZeneca
- Enrollment
- 9,284
- Locations
- 1
- Primary Endpoint
- MI, unstable angina with urgent revascularization, stroke, and death for any cause
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
MI, unstable angina with urgent revascularization, stroke, and death for any cause
Time Frame: 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
Time Frame: 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 Outcomes
- Bleeding events which require medical attention(in a 3 year follow-up period)
- Ischemic events (MI, unstable angina with urgent revascularization, ischemic stroke, CV death or death with unknown reason)(in a 3-year follow-up period)