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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01866904
First received: May 29, 2013
Last updated: June 10, 2015
Last verified: June 2015
  Purpose

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
Stable Coronary Artery Disease (CAD), Myocardial Infarction

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 10570
Study Start Date: June 2013
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
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

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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.
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01866904

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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01866904     History of Changes
Other Study ID Numbers: NIS-CMC-DUM-2013/1
Study First Received: May 29, 2013
Last Updated: June 10, 2015
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
Romania: National Medicines Agency
Finland: Finnish Medicines Agency (FIMEA)
Turkey: Ministry of Health of Turkey General Directorate of Pharmaceuticals and Pharmacy
India: Drug Controller General of India (DCGI)
Portugal: Ministério da Saúde (Ministry of Health)
Argentina: Dirección Nacional de Protección de Datos Personales - ICF submission only; Registro Nacional de Investigaciones en Salud (ReNIS) - study registration
Brazil: Comissão Nacional de Ética em Pesquisa - CONEP
Colombia: Instituto Nacional de Vigilancia de Medicamentos y Alimentos - INVIMA
Mexico: Comisión Federal para la Protección contra Riesgos Sanitarios - COFEPRIS
Venezuela: Instituto Nacional de Higiene "Rafael Rangel" - Centro Nacional de Vigilancia Farmacológica - CENAVIF

Keywords provided by AstraZeneca:
Coronary artery disease, Myocardial infarction

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Infarction
Myocardial Infarction
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on August 27, 2015