Overview

This trial is active, not recruiting.

Condition stable coronary artery disease (cad), myocardial infarction
Sponsor AstraZeneca
Start date June 2013
End date September 2017
Trial size 10570 participants
Trial identifier NCT01866904, NIS-CMC-DUM-2013/1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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

Primary Outcomes

Measure
MI, unstable angina with urgent revascularization, stroke, and death for any cause
time frame: in a 3-year follow-up period
Healthcare resource utilization
time frame: in a 3-year follow-up period

Secondary Outcomes

Measure
Ischemic events (MI, unstable angina with urgent revascularization, ischemic stroke, CV death or death with unknown reason)
time frame: in a 3-year follow-up period
Bleeding events which require medical attention
time frame: in a 3 year follow-up period

Eligibility Criteria

Male or female participants at least 50 years old.

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.

Additional Information

Official title TIGRIS: Long-Term rIsk, Clinical manaGement and Healthcare Resource Utilization of Stable Coronary Artery dISease in Post Myocardial Infarction Patients
Principal investigator David Brieger, MBBS, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.