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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01866904
First received: May 29, 2013
Last updated: September 16, 2014
Last verified: September 2014

May 29, 2013
September 16, 2014
June 2013
September 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
 
Recruiting
10570
September 2017
September 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.
Both
50 Years and older
No
Contact: AstraZeneca Information (Outside US) 001-800-236-9933
Contact: AstraZeneca Clinical Study Information (US) 800-236-9933 information.center@astrazeneca.com
India,   United States,   Argentina,   Australia,   Belgium,   Brazil,   Canada,   China,   Colombia,   Denmark,   Finland,   France,   Germany,   Venezuela,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Norway,   Portugal,   Romania,   Spain,   Turkey,   United Kingdom
 
NCT01866904
NIS-CMC-DUM-2013/1
No
AstraZeneca
AstraZeneca
Not Provided
Study Chair: Lin Zhang, M.D., PhD AstraZeneca GMA
Principal Investigator: David Brieger, MBBS, PhD Concord Repatriation General Hospital
AstraZeneca
September 2014

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