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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01866904 |
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Date of registration:
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29/05/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Long-Term rIsk, Clinical manaGement and Healthcare Resource Utilization of Stable CAD in Post MI Patients
TIGRIS |
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Scientific title:
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TIGRIS: Long-Term rIsk, Clinical manaGement and Healthcare Resource Utilization of Stable Coronary Artery dISease in Post Myocardial Infarction Patients |
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Date of first enrolment:
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June 19, 2013 |
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Target sample size:
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9284 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01866904 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Argentina
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Australia
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Belgium
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Brazil
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Canada
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China
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Colombia
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Denmark
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Finland
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France
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Germany
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India
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Italy
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Japan
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Korea, Republic of
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Mexico
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Netherlands
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Norway
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Portugal
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Romania
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Spain
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Turkey
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United Kingdom
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United States
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Venezuela
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Contacts
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Name:
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David Brieger, MBBS, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Concord Repatriation General Hospital |
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Name:
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Lin Zhang, M.D., PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca GMA |
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Key inclusion & exclusion criteria
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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.
Age minimum:
50 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Stable Coronary Artery Disease (CAD), Myocardial Infarction
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Primary Outcome(s)
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Healthcare resource utilization
[Time Frame: in a 3-year follow-up period]
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MI, unstable angina with urgent revascularization, stroke, and death for any cause
[Time Frame: in a 3-year follow-up period]
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Secondary Outcome(s)
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Bleeding events which require medical attention
[Time Frame: in a 3 year follow-up period]
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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]
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Secondary ID(s)
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NIS-CMC-DUM-2013/1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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