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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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ClinicalTrials.gov Identifier: NCT01866904
Recruitment Status : Terminated (Study was terminated in order to secure the data quality of the study in terms of follow-up rates and data completeness.)
First Posted : June 3, 2013
Last Update Posted : September 4, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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.

Condition or disease
Stable Coronary Artery Disease (CAD), Myocardial Infarction

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
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Study Type : Observational
Actual Enrollment : 9284 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: TIGRIS: Long-Term rIsk, Clinical manaGement and Healthcare Resource Utilization of Stable Coronary Artery dISease in Post Myocardial Infarction Patients
Actual Study Start Date : June 19, 2013
Actual Primary Completion Date : March 31, 2017
Actual Study Completion Date : March 31, 2017

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01866904


Locations
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Sponsors and Collaborators
AstraZeneca
Investigators
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Study Chair: Lin Zhang, M.D., PhD AstraZeneca GMA
Principal Investigator: David Brieger, MBBS, PhD Concord Repatriation General Hospital
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01866904    
Other Study ID Numbers: NIS-CMC-DUM-2013/1
First Posted: June 3, 2013    Key Record Dates
Last Update Posted: September 4, 2018
Last Verified: August 2018
Keywords provided by AstraZeneca:
Coronary artery disease, Myocardial infarction
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
 Necrosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases