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

• ClinicalTrials.gov Identifier: NCT01866904
• Recruitment Status: Terminated
• First Posted: June 3, 2013
• Last Update Posted: September 4, 2018
• Sponsor: AstraZeneca
• Information provided by (Responsible Party): AstraZeneca

Tracking Information

• First Submitted Date: May 29, 2013
• First Posted Date: June 3, 2013
• Last Update Posted Date: September 4, 2018
• Actual Study Start Date: June 19, 2013
• Actual Primary Completion Date: March 31, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 31, 2013)

• 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 31, 2013)

• 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 ]
  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.
• Bleeding events which require medical attention [ Time Frame: in a 3 year follow-up period ]
  To describe the rate of bleeding events requiring medical attention.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Long-Term rIsk, Clinical manaGement and Healthcare Resource Utilization of Stable CAD in Post MI Patients
• Official Title: TIGRIS: Long-Term rIsk, Clinical manaGement and Healthcare Resource Utilization of Stable Coronary Artery dISease in Post Myocardial Infarction Patients
• 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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: 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 at least one additional risk factor for atherothrombotic events
• Condition: Stable Coronary Artery Disease (CAD), Myocardial Infarction
• Intervention: Not Provided

Study Groups/Cohorts

Stable CAD patients aged 50 years or older

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

Publications *

• Carnicelli AP, Owen R, Pocock SJ, Brieger DB, Yasuda S, Nicolau JC, Goodman SG, Cohen MG, Simon T, Westermann D, Hedman K, Andersson Sundell K, Granger CB. Atrial fibrillation and clinical outcomes 1 to 3 years after myocardial infarction. Open Heart. 2021 Dec;8(2). pii: e001726. doi: 10.1136/openhrt-2021-001726.
• Russo JJ, Yan AT, Pocock SJ, Brieger D, Owen R, Sundell KA, Bagai A, Granger CB, Cohen MG, Yasuda S, Nicolau JC, Brandrup-Wognsen G, Westermann D, Simon T, Goodman SG. Determinants of long-term dual antiplatelet therapy use in post myocardial infarction patients: Insights from the TIGRIS registry. J Cardiol. 2022 Apr;79(4):522-529. doi: 10.1016/j.jjcc.2021.10.024. Epub 2021 Nov 29.
• Pocock S, Brieger DB, Owen R, Chen J, Cohen MG, Goodman S, Granger CB, Nicolau JC, Simon T, Westermann D, Yasuda S, Hedman K, Mellström C, Andersson Sundell K, Grieve R. Health-related quality of life 1-3 years post-myocardial infarction: its impact on prognosis. Open Heart. 2021 Feb;8(1). pii: e001499. doi: 10.1136/openhrt-2020-001499.
• Nicolau JC, Brieger D, Owen R, Furtado RHM, Goodman SG, Cohen MG, Simon T, Westermann D, Granger CB, Grieve R, Yasuda S, Chen J, Hedman K, Mellström C, Brandrup-Wognsen G, Pocock SJ. Diabetes association with self-reported health, resource utilization, and prognosis post-myocardial infarction. Clin Cardiol. 2020 Dec;43(12):1352-1361. doi: 10.1002/clc.23476. Epub 2020 Nov 4.
• Westermann D, Goodman SG, Nicolau JC, Requena G, Maguire A, Chen JY, Granger CB, Grieve R, Pocock SJ, Blankenberg S, Vega AM, Yasuda S, Simon T, Brieger D; TIGRIS Study Investigators. Rationale and design of the long-Term rIsk, clinical manaGement, and healthcare Resource utilization of stable coronary artery dISease in post-myocardial infarction patients (TIGRIS) study. Clin Cardiol. 2017 Dec;40(12):1197-1204. doi: 10.1002/clc.22837. Epub 2017 Dec 16.
• Goodman SG, Nicolau JC, Requena G, Maguire A, Blankenberg S, Chen JY, Granger CB, Grieve R, Pocock SJ, Simon T, Yasuda S, Vega AM, Brieger D; TIGRIS Study Investigators. Longer-term oral antiplatelet use in stable post-myocardial infarction patients: Insights from the long Term rIsk, clinical manaGement and healthcare Resource utilization of stable coronary artery dISease (TIGRIS) observational study. Int J Cardiol. 2017 Jun 1;236:54-60. doi: 10.1016/j.ijcard.2017.02.062. Epub 2017 Feb 21.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: May 29, 2017): 9284
• Original Estimated Enrollment (submitted: May 31, 2013): 10170
• Actual Study Completion Date: March 31, 2017
• Actual Primary Completion Date: March 31, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Australia, Belgium, Brazil, Canada, China, Colombia, Denmark, Finland, France, Germany, India, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Norway, Portugal, Romania, Spain, Turkey, United Kingdom, United States, Venezuela

Administrative Information

• NCT Number: NCT01866904
• Other Study ID Numbers: NIS-CMC-DUM-2013/1
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: AstraZeneca
• Original Responsible Party: Same as current
• Current Study Sponsor: AstraZeneca
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Lin Zhang, M.D., PhD; AstraZeneca GMA
• Principal Investigator: David Brieger, MBBS, PhD; Concord Repatriation General Hospital

• PRS Account: AstraZeneca
• Verification Date: August 2018