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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01866904




Registration number
NCT01866904
Ethics application status
Date submitted
29/05/2013
Date registered
3/06/2013
Date last updated
4/09/2018

Titles & IDs
Public title
Long-Term rIsk, Clinical manaGement and Healthcare Resource Utilization of Stable CAD in Post MI Patients
Scientific title
TIGRIS: Long-Term rIsk, Clinical manaGement and Healthcare Resource Utilization of Stable Coronary Artery dISease in Post Myocardial Infarction Patients
Secondary ID [1] 0 0
NIS-CMC-DUM-2013/1
Universal Trial Number (UTN)
Trial acronym
TIGRIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stable Coronary Artery Disease (CAD), Myocardial Infarction 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
MI, unstable angina with urgent revascularization, stroke, and death for any cause
Timepoint [1] 0 0
in a 3-year follow-up period
Primary outcome [2] 0 0
Healthcare resource utilization
Timepoint [2] 0 0
in a 3-year follow-up period
Secondary outcome [1] 0 0
Ischemic events (MI, unstable angina with urgent revascularization, ischemic stroke, CV death or death with unknown reason)
Timepoint [1] 0 0
in a 3-year follow-up period
Secondary outcome [2] 0 0
Bleeding events which require medical attention
Timepoint [2] 0 0
in a 3 year follow-up period

Eligibility
Key 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.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/06/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/03/2017
Sample size
Target
Accrual to date
Final
9284
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Coffs Harbour
Recruitment hospital [2] 0 0
Research Site - Concord
Recruitment hospital [3] 0 0
Research Site - Kogarh
Recruitment hospital [4] 0 0
Research Site - Liverpool
Recruitment hospital [5] 0 0
Research Site - Newcastele
Recruitment hospital [6] 0 0
Research Site - St Leonards
Recruitment hospital [7] 0 0
Research Site - Wollongong
Recruitment hospital [8] 0 0
Research Site - Brisbane
Recruitment hospital [9] 0 0
Research Site - Nambour
Recruitment hospital [10] 0 0
Research Site - Southport
Recruitment hospital [11] 0 0
Research Site - Woolloongabba
Recruitment hospital [12] 0 0
Research Site - Epping
Recruitment hospital [13] 0 0
Research Site - Parkville
Recruitment hospital [14] 0 0
Research Site - Richmond
Recruitment hospital [15] 0 0
Research Site - Fremantle
Recruitment hospital [16] 0 0
Research Site - Nedlands
Recruitment postcode(s) [1] 0 0
- Coffs Harbour
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- Concord
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- Kogarh
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- Liverpool
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- Newcastele
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- St Leonards
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- Wollongong
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- Brisbane
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- Nambour
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- Southport
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- Woolloongabba
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- Epping
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- Parkville
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- Richmond
Recruitment postcode(s) [15] 0 0
- Fremantle
Recruitment postcode(s) [16] 0 0
- Nedlands
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Almeria
Country [232] 0 0
Spain
State/province [232] 0 0
Lleida
Country [233] 0 0
Spain
State/province [233] 0 0
Madrid
Country [234] 0 0
Spain
State/province [234] 0 0
Murcia
Country [235] 0 0
Turkey
State/province [235] 0 0
Ankara
Country [236] 0 0
Turkey
State/province [236] 0 0
Aydin
Country [237] 0 0
Turkey
State/province [237] 0 0
Diyarbak?r
Country [238] 0 0
Turkey
State/province [238] 0 0
Istanbul
Country [239] 0 0
Turkey
State/province [239] 0 0
Merkez
Country [240] 0 0
Turkey
State/province [240] 0 0
Mersin
Country [241] 0 0
United Kingdom
State/province [241] 0 0
Airdrie
Country [242] 0 0
United Kingdom
State/province [242] 0 0
Cambridge
Country [243] 0 0
United Kingdom
State/province [243] 0 0
East Kilbride
Country [244] 0 0
United Kingdom
State/province [244] 0 0
London
Country [245] 0 0
United Kingdom
State/province [245] 0 0
Portadown
Country [246] 0 0
United Kingdom
State/province [246] 0 0
Sheffield
Country [247] 0 0
United Kingdom
State/province [247] 0 0
Taunton
Country [248] 0 0
United Kingdom
State/province [248] 0 0
Wolverhampton
Country [249] 0 0
Venezuela
State/province [249] 0 0
Carabobo
Country [250] 0 0
Venezuela
State/province [250] 0 0
Miranda

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01866904
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lin Zhang, M.D., PhD
Address 0 0
AstraZeneca GMA
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01866904