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

This study has been terminated.
(Study was terminated in order to secure the data quality of the study in terms of follow-up rates and data completeness.)
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01866904
First received: May 29, 2013
Last updated: May 29, 2017
Last verified: May 2017
May 29, 2013
May 29, 2017
June 19, 2013
March 31, 2017   (Final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01866904 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Long-Term rIsk, Clinical manaGement and Healthcare Resource Utilization of Stable CAD in Post MI Patients
TIGRIS: Long-Term rIsk, Clinical manaGement and Healthcare Resource Utilization of Stable Coronary Artery dISease in Post Myocardial Infarction Patients
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
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
Stable Coronary Artery Disease (CAD), Myocardial Infarction
Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9284
March 31, 2017
March 31, 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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
 
 
NCT01866904
NIS-CMC-DUM-2013/1
No
Not Provided
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Chair: Lin Zhang, M.D., PhD AstraZeneca GMA
Principal Investigator: David Brieger, MBBS, PhD Concord Repatriation General Hospital
AstraZeneca
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP