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

AstraZeneca

Status: Terminated

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

Study type: Observational

Funder types: Industry

Identifiers

NCT01866904

NIS-CMC-DUM-2013/1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9,284 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

9,284 participants in 1 patient group

Stable CAD patients aged 50 years or older

Description:

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 additional risk factor