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

August 30, 2018 updated by: AstraZeneca

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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

9284

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Buenos Aires, Argentina
        • Research Site
      • Cordoba, Argentina
        • Research Site
      • Corrientes, Argentina
        • Research Site
      • Mendoza, Argentina
        • Research Site
      • Salta, Argentina
        • Research Site
      • Santa Fe de la Vera Cruz, Argentina
        • Research Site
    • New South Wales
      • Coffs Harbour, New South Wales, Australia
        • Research Site
      • Concord, New South Wales, Australia
        • Research Site
      • Kogarh, New South Wales, Australia
        • Research Site
      • Liverpool, New South Wales, Australia
        • Research Site
      • Newcastele, New South Wales, Australia
        • Research Site
      • St Leonards, New South Wales, Australia
        • Research Site
      • Wollongong, New South Wales, Australia
        • Research Site
    • Queensland
      • Brisbane, Queensland, Australia
        • Research Site
      • Nambour, Queensland, Australia
        • Research Site
      • Southport, Queensland, Australia
        • Research Site
      • Woolloongabba, Queensland, Australia
        • Research Site
    • Victoria
      • Epping, Victoria, Australia
        • Research Site
      • Parkville, Victoria, Australia
        • Research Site
      • Richmond, Victoria, Australia
        • Research Site
    • Western Australia
      • Fremantle, Western Australia, Australia
        • Research Site
      • Nedlands, Western Australia, Australia
        • Research Site
      • Aalst, Belgium
        • Research Site
      • Bonheiden, Belgium
        • Research Site
      • Brasschaat, Belgium
        • Research Site
      • Bruxelles, Belgium
        • Research Site
      • Genk, Belgium
        • Research Site
      • Gent, Belgium
        • Research Site
      • Kortrijk, Belgium
        • Research Site
      • Oostende, Belgium
        • Research Site
      • Overpelt, Belgium
        • Research Site
      • Veurne, Belgium
        • Research Site
    • Mato Grosso Do Sul
      • Campo Grande, Mato Grosso Do Sul, Brazil
        • Research Site
    • Santa Cantarina
      • Blumenal, Santa Cantarina, Brazil
        • Research Site
    • Sao Paulo
      • Marilia, Sao Paulo, Brazil
        • Research Site
      • Sao Jose do Rio Preto, Sao Paulo, Brazil
        • Research Site
      • Quebec, Canada
        • Research Site
    • New Brunswick
      • Saint John, New Brunswick, Canada
        • Research Site
    • Ontario
      • Brampton, Ontario, Canada
        • Research Site
      • Cambridge, Ontario, Canada
        • Research Site
      • Hamilton, Ontario, Canada
        • Research Site
      • London, Ontario, Canada
        • Research Site
      • Newmarket, Ontario, Canada
        • Research Site
      • North York, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
      • Windsor, Ontario, Canada
        • Research Site
    • Quebec
      • Greenfield Park, Quebec, Canada
        • Research Site
      • Montreal, Quebec, Canada
        • Research Site
      • Saint-Jerome, Quebec, Canada
        • Research Site
      • Thetford Mines, Quebec, Canada
        • Research Site
    • Beijing
      • Beijing, Beijing, China
        • Research Site
    • Chongqing
      • Chongqing, Chongqing, China
        • Research Site
    • Gansu
      • Lanzhou, Gansu, China
        • Research Site
    • Guangdong
      • Guangzhou, Guangdong, China
        • Research Site
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Research Site
      • Wuxi, Jiangsu, China
        • Research Site
      • Zhenjiang, Jiangsu, China
        • Research Site
    • Jilin
      • Changchun, Jilin, China
        • Research Site
    • Liaoning
      • Jinzhou, Liaoning, China
        • Research Site
    • Shandong
      • Jinan, Shandong, China
        • Research Site
    • Shanghai
      • Shanghai, Shanghai, China
        • Research Site
    • Shanxi
      • Xian, Shanxi, China
        • Research Site
    • Shanyuan
      • Taiyuan, Shanyuan, China
        • Research Site
    • Tianjin
      • Tianjin, Tianjin, China
        • Research Site
    • Yunnan
      • Kunming, Yunnan, China
        • Research Site
    • Antioquia
      • Medellin, Antioquia, Colombia
        • Research Site
    • Atlantico
      • Barranquilla, Atlantico, Colombia
        • Research Site
    • Caldas
      • Cartagena, Caldas, Colombia
        • Research Site
      • Manizales, Caldas, Colombia
        • Research Site
    • Santander Dept
      • Bucaramanga, Santander Dept, Colombia
        • Research Site
    • Valle Del Cauca
      • Cali, Valle Del Cauca, Colombia
        • Research Site
      • Alborg, Denmark
        • Research Site
      • Haderslev, Denmark
        • Research Site
      • Hellerup, Denmark
        • Research Site
      • Kobenhavn, Denmark
        • Research Site
      • Kobenhavn NV, Denmark
        • Research Site
      • Kobenhavn S, Denmark
        • Research Site
      • Randers, Denmark
        • Research Site
      • arhus N, Denmark
        • Research Site
      • Jyvaskyla, Finland
        • Research Site
      • Rovaniemi, Finland
        • Research Site
      • Tampere, Finland
        • Research Site
      • Turku, Finland
        • Research Site
      • Abbeville, France
        • Research Site
      • Arras, France
        • Research Site
      • Boulogne-Billancourt, France
        • Research Site
      • Briis Sous Forge, France
        • Research Site
      • Corbeille Essone, France
        • Research Site
      • Dijon Cedex, France
        • Research Site
      • La Rochelle, France
        • Research Site
      • Langres, France
        • Research Site
      • Le Chesnay, France
        • Research Site
      • Le Coudray, France
        • Research Site
      • Lyon, France
        • Research Site
      • Marseille, France
        • Research Site
      • Nice Cedex 1, France
        • Research Site
      • Roubaix, France
        • Research Site
      • Salouel, France
        • Research Site
      • Toulouse, France
        • Research Site
      • Berlin, Germany
        • Research Site
      • Bochum, Germany
        • Research Site
      • Chemnitz, Germany
        • Research Site
      • Cloppenburg, Germany
        • Research Site
      • Coburg, Germany
        • Research Site
      • Dresden, Germany
        • Research Site
      • Erfurt, Germany
        • Research Site
      • Erlangen, Germany
        • Research Site
      • Essen, Germany
        • Research Site
      • Frankfurt, Germany
        • Research Site
      • Frankfurt M, Germany
        • Research Site
      • Hamburg, Germany
        • Research Site
      • Heidelberg, Germany
        • Research Site
      • Kiel, Germany
        • Research Site
      • Koblenz, Germany
        • Research Site
      • Koln, Germany
        • Research Site
      • Leipzig, Germany
        • Research Site
      • Leverkusen, Germany
        • Research Site
      • Lubeck, Germany
        • Research Site
      • Ludwigshafen, Germany
        • Research Site
      • Mainz, Germany
        • Research Site
      • Merseburg, Germany
        • Research Site
      • Monchengladbach, Germany
        • Research Site
      • Munchen, Germany
        • Research Site
      • Potsdam, Germany
        • Research Site
      • Soltau, Germany
        • Research Site
      • Stuttgart, Germany
        • Research Site
      • Ulm, Germany
        • Research Site
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India
        • Research Site
    • Delhi
      • New Delhi, Delhi, India
        • Research Site
    • Gujarat
      • Surat, Gujarat, India
        • Research Site
    • Karnataka
      • Bangalore, Karnataka, India
        • Research Site
    • Kerala
      • Thrisur, Kerala, India
        • Research Site
      • Trivandrum, Kerala, India
        • Research Site
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India
        • Research Site
    • Maharashtra
      • Mumbai, Maharashtra, India
        • Research Site
      • Pune, Maharashtra, India
        • Research Site
    • Punjab
      • Mohali, Punjab, India
        • Research Site
    • Rajasthan
      • Jaipur, Rajasthan, India
        • Research Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India
        • Research Site
      • Madurai, Tamil Nadu, India
        • Research Site
    • Uttar Pradesh
      • Noida, Uttar Pradesh, India
        • Research Site
    • West Bengal
      • Kolkata, West Bengal, India
        • Research Site
      • Ancona, Italy
        • Research Site
      • Bologna, Italy
        • Research Site
      • Catania, Italy
        • Research Site
      • Lagosanto FE, Italy
        • Research Site
      • Lido di Camaiore, Italy
        • Research Site
      • Massa Carrara, Italy
        • Research Site
      • Milano, Italy
        • Research Site
      • Napoli, Italy
        • Research Site
      • Nuoro, Italy
        • Research Site
      • Palermo, Italy
        • Research Site
      • Perugia, Italy
        • Research Site
      • Prato, Italy
        • Research Site
      • Sassari, Italy
        • Research Site
      • Treviso, Italy
        • Research Site
    • Aichi
      • Toyoake-shi, Aichi, Japan
        • Research Site
    • Chiba
      • Chiba-shi, Chiba, Japan
        • Research Site
      • Kisarazu-shi, Chiba, Japan
        • Research Site
    • Ehime
      • Matsuyama-shi, Ehime, Japan
        • Research Site
    • Fukui
      • Fukui-shi, Fukui, Japan
        • Research Site
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan
        • Research Site
      • Kurume-shi, Fukuoka, Japan
        • Research Site
    • Gunma
      • Maebashi-shi, Gunma, Japan
        • Research Site
    • Hiroshima
      • Hiroshima-shi, Hiroshima, Japan
        • Research Site
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan
        • Research Site
      • Tomakomai-shi, Hokkaido, Japan
        • Research Site
    • Hyogo
      • Amagasaki-shi, Hyogo, Japan
        • Research Site
    • Ishikawa
      • Kanazawa-shi, Ishikawa, Japan
        • Research Site
    • Iwate
      • Morioka-shi, Iwate, Japan
        • Research Site
    • Kanagawa
      • Isehara-shi, Kanagawa, Japan
        • Research Site
      • Sagamihara-shi, Kanagawa, Japan
        • Research Site
      • Yokohama-shi, Kanagawa, Japan
        • Research Site
    • Kouchi
      • Kouchi-shi, Kouchi, Japan
        • Research Site
    • Kumamoto
      • Kumamoto-shi, Kumamoto, Japan
        • Research Site
    • Miyagi
      • Sendai-shi, Miyagi, Japan
        • Research Site
    • Nara
      • Tenri-shi, Nara, Japan
        • Research Site
    • Osaka
      • Hirakata-shi, Osaka, Japan
        • Research Site
      • Osaka-shi, Osaka, Japan
        • Research Site
      • Suita-shi, Osaka, Japan
        • Research Site
    • Shiga
      • Kusatsu-shi, Shiga, Japan
        • Research Site
    • Shizuoka
      • Izunokuni-shi, Shizuoka, Japan
        • Research Site
      • Shizuoka-shi, Shizuoka, Japan
        • Research Site
    • Tokushima
      • Komatsujima-shi, Tokushima, Japan
        • Research Site
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan
        • Research Site
      • Chuo-Ku, Tokyo, Japan
        • Research Site
    • Wakayama
      • Wakayama-shi, Wakayama, Japan
        • Research Site
    • Cheongju-si
      • Chungcheongbuk-do, Cheongju-si, Korea, Republic of
        • Research Site
    • Gangwon-do
      • Wonju-si, Gangwon-do, Korea, Republic of
        • Research Site
    • Gyeongsangnam-do
      • Jinju, Gyeongsangnam-do, Korea, Republic of
        • Research Site
    • Jeollabuk-do
      • Jeonju-si, Jeollabuk-do, Korea, Republic of
        • Research Site
    • Jung-gu
      • Daejeon, Jung-gu, Korea, Republic of
        • Research Site
    • Nam-gu
      • Daegu, Nam-gu, Korea, Republic of
        • Research Site
    • Seo-gu
      • Busan, Seo-gu, Korea, Republic of
        • Research Site
    • South Jeolla
      • Gwangju, South Jeolla, Korea, Republic of
        • Research Site
    • Sudogwon
      • Seoul, Sudogwon, Korea, Republic of
        • Research Site
      • Chihuahua, Mexico
        • Research Site
      • Oaxaca, Mexico
        • Research Site
      • Puebla, Mexico
        • Research Site
      • San Luis Potosi, Mexico
        • Research Site
    • Baja California
      • Tijuana, Baja California, Mexico
        • Research Site
    • Coahuila
      • Torreon, Coahuila, Mexico
        • Research Site
    • Distrito Federal
      • Ciudad de Mexico, Distrito Federal, Mexico
        • Research Site
    • Estado De Mexico
      • Toluca, Estado De Mexico, Mexico
        • Research Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico
        • Research Site
    • Queretaro De Arteaga
      • Queretaro, Queretaro De Arteaga, Mexico
        • Research Site
      • Amsterdam, Netherlands
        • Research Site
      • Arnhem, Netherlands
        • Research Site
      • Blaricum, Netherlands
        • Research Site
      • Delft, Netherlands
        • Research Site
      • Den Haag, Netherlands
        • Research Site
      • Doetinchem, Netherlands
        • Research Site
      • Ede, Netherlands
        • Research Site
      • Groningen, Netherlands
        • Research Site
      • Haarlem, Netherlands
        • Research Site
      • Hardenberg, Netherlands
        • Research Site
      • Heerlen, Netherlands
        • Research Site
      • Hoofddorp, Netherlands
        • Research Site
      • Hoogeveen, Netherlands
        • Research Site
      • IJssel, Netherlands
        • Research Site
      • Meppel, Netherlands
        • Research Site
      • Sittard-Geleen, Netherlands
        • Research Site
      • Zutphen, Netherlands
        • Research Site
      • Fredrikstad, Norway
        • Research Site
      • Oslo, Norway
        • Research Site
      • Stavanger, Norway
        • Research Site
      • Braga, Portugal
        • Research Site
      • Canelas, Portugal
        • Research Site
      • Faro, Portugal
        • Research Site
      • Lisboa, Portugal
        • Research Site
      • Porto, Portugal
        • Research Site
      • Senhora da Hora, Portugal
        • Research Site
      • Setubal, Portugal
        • Research Site
      • Viana do Castelo, Portugal
        • Research Site
      • Arad, Romania
        • Research Site
      • Braila, Romania
        • Research Site
      • Bucuresti, Romania
        • Research Site
      • Cluj Napoca, Romania
        • Research Site
      • Craiova, Romania
        • Research Site
      • Drobeta - Turnu Severin, Romania
        • Research Site
      • Focsani, Romania
        • Research Site
      • Pitesti, Romania
        • Research Site
      • Sibiu, Romania
        • Research Site
      • Slatina, Romania
        • Research Site
      • Timisoara, Romania
        • Research Site
      • Alicante, Spain
        • Research Site
      • Almeria, Spain
        • Research Site
      • Granada, Spain
        • Research Site
      • Lleida, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Murcia, Spain
        • Research Site
    • Andalusia
      • Sevilla, Andalusia, Spain
        • Research Site
    • Balearic Islands
      • Palma de Mallorca, Balearic Islands, Spain
        • Research Site
    • Castile-La Mancha
      • Toledo, Castile-La Mancha, Spain
        • Research Site
    • Catalonia
      • Barcelona, Catalonia, Spain
        • Research Site
      • Vic, Catalonia, Spain
        • Research Site
    • Extremadura
      • Caceres, Extremadura, Spain
        • Research Site
    • Galicia
      • Santiago de Compostela, Galicia, Spain
        • Research Site
    • Granada
      • Baza, Granada, Spain
        • Research Site
      • Ankara, Turkey
        • Research Site
      • Aydin, Turkey
        • Research Site
      • Diyarbak?r, Turkey
        • Research Site
      • Istanbul, Turkey
        • Research Site
      • Merkez, Turkey
        • Research Site
      • Mersin, Turkey
        • Research Site
      • Airdrie, United Kingdom
        • Research Site
      • Cambridge, United Kingdom
        • Research Site
      • East Kilbride, United Kingdom
        • Research Site
      • London, United Kingdom
        • Research Site
      • Portadown, United Kingdom
        • Research Site
      • Sheffield, United Kingdom
        • Research Site
      • Taunton, United Kingdom
        • Research Site
      • Wolverhampton, United Kingdom
        • Research Site
    • Alabama
      • Huntsville, Alabama, United States
        • Research Site
    • California
      • Los Angeles, California, United States
        • Research Site
      • Santa Ana, California, United States
        • Research Site
      • Torrance, California, United States
        • Research Site
      • Ventura, California, United States
        • Research Site
    • Florida
      • Clearwater, Florida, United States
        • Research Site
      • Miami, Florida, United States
        • Research Site
      • Tallahassee, Florida, United States
        • Research Site
    • Georgia
      • Tucker, Georgia, United States
        • Research Site
    • Illinois
      • Arlington Heights, Illinois, United States
        • Research Site
      • Englewood, Illinois, United States
        • Research Site
    • Indiana
      • Lebanon, Indiana, United States
        • Research Site
    • Maine
      • Auburn, Maine, United States
        • Research Site
      • Bangor, Maine, United States
        • Research Site
    • Maryland
      • Columbia, Maryland, United States
        • Research Site
    • Michigan
      • Jackson, Michigan, United States
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Research Site
    • New York
      • Manhasset, New York, United States
        • Research Site
    • North Carolina
      • Chapel Hill, North Carolina, United States
        • Research Site
      • Durham, North Carolina, United States
        • Research Site
    • Ohio
      • Sandusky, Ohio, United States
        • Research Site
    • Pennsylvania
      • Abington, Pennsylvania, United States
        • Research Site
      • Doylestown, Pennsylvania, United States
        • Research Site
      • Pittsburgh, Pennsylvania, United States
        • Research Site
      • Sayre, Pennsylvania, United States
        • Research Site
    • Rhode Island
      • Providence, Rhode Island, United States
        • Research Site
    • Tennessee
      • Jackson, Tennessee, United States
        • Research Site
    • Texas
      • Houston, Texas, United States
        • Research Site
      • Plano, Texas, United States
        • Research Site
    • Vermont
      • Burlington, Vermont, United States
        • Research Site
    • Virginia
      • Falls Church, Virginia, United States
        • Research Site
      • Manassas, Virginia, United States
        • Research Site
    • Washington
      • Seattle, Washington, United States
        • Research Site
      • Spokane, Washington, United States
        • Research Site
    • Carabobo
      • Valencia, Carabobo, Venezuela
        • Research Site
    • Miranda
      • Caracas, Miranda, Venezuela
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
in a 3-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.
in a 3-year follow-up period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
in a 3-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.
in a 3 year follow-up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Chair: Lin Zhang, M.D., PhD, AstraZeneca GMA
  • Principal Investigator: David Brieger, MBBS, PhD, Concord Repatriation General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2013

Primary Completion (Actual)

March 31, 2017

Study Completion (Actual)

March 31, 2017

Study Registration Dates

First Submitted

May 29, 2013

First Submitted That Met QC Criteria

May 31, 2013

First Posted (Estimate)

June 3, 2013

Study Record Updates

Last Update Posted (Actual)

September 4, 2018

Last Update Submitted That Met QC Criteria

August 30, 2018

Last Verified

August 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stable Coronary Artery Disease (CAD), Myocardial Infarction

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