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History of Changes for Study: NCT01866904
Long-Term rIsk, Clinical manaGement and Healthcare Resource Utilization of Stable CAD in Post MI Patients (TIGRIS)
Latest version (submitted August 30, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 31, 2013 None (earliest Version on record)
2 June 24, 2013 Recruitment Status, Study Status, Conditions, Contacts/Locations, Study Design and Oversight
3 September 25, 2013 Contacts/Locations and Study Status
4 October 28, 2013 Study Status
5 December 17, 2013 Contacts/Locations and Study Status
6 March 27, 2014 Contacts/Locations and Study Status
7 June 26, 2014 Study Status
8 August 13, 2014 Contacts/Locations and Study Status
9 September 16, 2014 Study Status
10 November 14, 2014 Study Status
11 December 12, 2014 Recruitment Status, Contacts/Locations and Study Status
12 March 10, 2015 Contacts/Locations and Study Status
13 June 10, 2015 Contacts/Locations and Study Status
14 September 3, 2015 Study Status
15 December 3, 2015 Study Status
16 March 3, 2016 Study Status and Study Design
17 June 15, 2016 Study Status
18 September 12, 2016 Study Status
19 December 7, 2016 Study Status
20 March 1, 2017 Study Status
21 May 4, 2017 Recruitment Status, Study Status and Contacts/Locations
22 May 29, 2017 Recruitment Status, Study Status and Study Design
23 August 30, 2018 Study Status, References and Contacts/Locations
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Study NCT01866904
Submitted Date:  May 31, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: NIS-CMC-DUM-2013/1
Brief Title: Long-Term rIsk, Clinical manaGement and Healthcare Resource Utilization of Stable CAD in Post MI Patients (TIGRIS)
Official Title: TIGRIS: Long-Term rIsk, Clinical manaGement and Healthcare Resource Utilization of Stable Coronary Artery dISease in Post Myocardial Infarction Patients
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2013
Overall Status: Not yet recruiting
Study Start: June 2013
Primary Completion: September 2017 [Anticipated]
Study Completion: September 2017 [Anticipated]
First Submitted: May 29, 2013
First Submitted that
Met QC Criteria:
May 31, 2013
First Posted: June 3, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
May 31, 2013
Last Update Posted: June 3, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: AstraZeneca
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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.
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.

Open or close this module Conditions
Conditions: Stable Coronary Artery Disease (CAD)
Myocardial Infarction
Keywords: Coronary artery disease
Myocardial infarction
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 10170 [Anticipated]
Number of Groups/Cohorts 1
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
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
Open or close this module Outcome Measures
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.
Open or close this module Eligibility
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
Sampling Method: Probability Sample
Minimum Age: 50 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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.
Open or close this module Contacts/Locations
Central Contact Person: Jo Chung, DVM, MS
Telephone: +886-2-2737-8669
Study Officials: Lin Zhang, M.D., PhD
Study Chair
AstraZeneca GMA
David Brieger, MBBS, PhD
Principal Investigator
Concord Repatriation General Hospital
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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