- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01866904
Long-Term rIsk, Clinical manaGement and Healthcare Resource Utilization of Stable CAD in Post MI Patients (TIGRIS)
TIGRIS: Long-Term rIsk, Clinical manaGement and Healthcare Resource Utilization of Stable Coronary Artery dISease in Post Myocardial Infarction Patients
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Buenos Aires, Argentina
- Research Site
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Cordoba, Argentina
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Corrientes, Argentina
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Mendoza, Argentina
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Salta, Argentina
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Santa Fe de la Vera Cruz, Argentina
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New South Wales
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Coffs Harbour, New South Wales, Australia
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Concord, New South Wales, Australia
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Kogarh, New South Wales, Australia
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Liverpool, New South Wales, Australia
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Newcastele, New South Wales, Australia
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St Leonards, New South Wales, Australia
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Wollongong, New South Wales, Australia
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Queensland
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Brisbane, Queensland, Australia
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Nambour, Queensland, Australia
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Southport, Queensland, Australia
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Woolloongabba, Queensland, Australia
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Victoria
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Epping, Victoria, Australia
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Parkville, Victoria, Australia
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Richmond, Victoria, Australia
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Western Australia
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Fremantle, Western Australia, Australia
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Nedlands, Western Australia, Australia
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Aalst, Belgium
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Bonheiden, Belgium
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Brasschaat, Belgium
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Bruxelles, Belgium
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Genk, Belgium
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Gent, Belgium
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Kortrijk, Belgium
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Oostende, Belgium
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Overpelt, Belgium
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Veurne, Belgium
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Mato Grosso Do Sul
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Campo Grande, Mato Grosso Do Sul, Brazil
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Santa Cantarina
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Blumenal, Santa Cantarina, Brazil
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Sao Paulo
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Marilia, Sao Paulo, Brazil
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Sao Jose do Rio Preto, Sao Paulo, Brazil
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Quebec, Canada
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New Brunswick
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Saint John, New Brunswick, Canada
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Ontario
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Brampton, Ontario, Canada
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Cambridge, Ontario, Canada
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Hamilton, Ontario, Canada
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London, Ontario, Canada
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Newmarket, Ontario, Canada
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North York, Ontario, Canada
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Toronto, Ontario, Canada
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Windsor, Ontario, Canada
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Quebec
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Greenfield Park, Quebec, Canada
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Montreal, Quebec, Canada
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Saint-Jerome, Quebec, Canada
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Thetford Mines, Quebec, Canada
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Beijing
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Beijing, Beijing, China
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Chongqing
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Chongqing, Chongqing, China
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Gansu
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Lanzhou, Gansu, China
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Guangdong
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Guangzhou, Guangdong, China
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Jiangsu
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Nanjing, Jiangsu, China
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Wuxi, Jiangsu, China
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Zhenjiang, Jiangsu, China
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Jilin
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Changchun, Jilin, China
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Liaoning
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Jinzhou, Liaoning, China
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Shandong
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Jinan, Shandong, China
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Shanghai
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Shanghai, Shanghai, China
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Shanxi
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Xian, Shanxi, China
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Shanyuan
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Taiyuan, Shanyuan, China
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Tianjin
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Tianjin, Tianjin, China
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Yunnan
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Kunming, Yunnan, China
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Antioquia
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Medellin, Antioquia, Colombia
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Atlantico
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Barranquilla, Atlantico, Colombia
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Caldas
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Cartagena, Caldas, Colombia
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Manizales, Caldas, Colombia
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Santander Dept
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Bucaramanga, Santander Dept, Colombia
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Valle Del Cauca
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Cali, Valle Del Cauca, Colombia
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Alborg, Denmark
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Haderslev, Denmark
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Hellerup, Denmark
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Kobenhavn, Denmark
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Kobenhavn NV, Denmark
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Kobenhavn S, Denmark
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Randers, Denmark
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arhus N, Denmark
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Jyvaskyla, Finland
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Rovaniemi, Finland
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Tampere, Finland
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Turku, Finland
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Abbeville, France
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Arras, France
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Boulogne-Billancourt, France
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Briis Sous Forge, France
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Corbeille Essone, France
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Dijon Cedex, France
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La Rochelle, France
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Langres, France
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Le Chesnay, France
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Le Coudray, France
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Lyon, France
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Marseille, France
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Nice Cedex 1, France
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Roubaix, France
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Salouel, France
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Toulouse, France
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Berlin, Germany
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Bochum, Germany
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Chemnitz, Germany
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Cloppenburg, Germany
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Coburg, Germany
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Dresden, Germany
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Erfurt, Germany
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Erlangen, Germany
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Essen, Germany
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Frankfurt, Germany
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Frankfurt M, Germany
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Hamburg, Germany
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Heidelberg, Germany
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Kiel, Germany
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Koblenz, Germany
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Koln, Germany
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Leipzig, Germany
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Leverkusen, Germany
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Lubeck, Germany
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Ludwigshafen, Germany
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Mainz, Germany
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Merseburg, Germany
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Monchengladbach, Germany
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Munchen, Germany
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Potsdam, Germany
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Soltau, Germany
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Stuttgart, Germany
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Ulm, Germany
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Andhra Pradesh
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Hyderabad, Andhra Pradesh, India
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Delhi
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New Delhi, Delhi, India
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Gujarat
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Surat, Gujarat, India
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Karnataka
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Bangalore, Karnataka, India
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Kerala
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Thrisur, Kerala, India
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Trivandrum, Kerala, India
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Madhya Pradesh
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Indore, Madhya Pradesh, India
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Maharashtra
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Mumbai, Maharashtra, India
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Pune, Maharashtra, India
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Punjab
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Mohali, Punjab, India
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Rajasthan
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Jaipur, Rajasthan, India
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Tamil Nadu
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Chennai, Tamil Nadu, India
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Madurai, Tamil Nadu, India
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Uttar Pradesh
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Noida, Uttar Pradesh, India
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West Bengal
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Kolkata, West Bengal, India
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Ancona, Italy
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Bologna, Italy
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Catania, Italy
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Lagosanto FE, Italy
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Lido di Camaiore, Italy
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Massa Carrara, Italy
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Milano, Italy
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Napoli, Italy
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Nuoro, Italy
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Palermo, Italy
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Perugia, Italy
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Prato, Italy
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Sassari, Italy
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Treviso, Italy
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Aichi
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Toyoake-shi, Aichi, Japan
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Chiba
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Chiba-shi, Chiba, Japan
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Kisarazu-shi, Chiba, Japan
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Ehime
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Matsuyama-shi, Ehime, Japan
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Fukui
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Fukui-shi, Fukui, Japan
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Fukuoka
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Fukuoka-shi, Fukuoka, Japan
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Kurume-shi, Fukuoka, Japan
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Gunma
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Maebashi-shi, Gunma, Japan
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Hiroshima
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Hiroshima-shi, Hiroshima, Japan
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Hokkaido
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Sapporo-shi, Hokkaido, Japan
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Tomakomai-shi, Hokkaido, Japan
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Hyogo
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Amagasaki-shi, Hyogo, Japan
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Ishikawa
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Kanazawa-shi, Ishikawa, Japan
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Iwate
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Morioka-shi, Iwate, Japan
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Kanagawa
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Isehara-shi, Kanagawa, Japan
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Sagamihara-shi, Kanagawa, Japan
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Yokohama-shi, Kanagawa, Japan
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Kouchi
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Kouchi-shi, Kouchi, Japan
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Kumamoto
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Kumamoto-shi, Kumamoto, Japan
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Miyagi
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Sendai-shi, Miyagi, Japan
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Nara
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Tenri-shi, Nara, Japan
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Osaka
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Hirakata-shi, Osaka, Japan
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Osaka-shi, Osaka, Japan
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Suita-shi, Osaka, Japan
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Shiga
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Kusatsu-shi, Shiga, Japan
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Shizuoka
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Izunokuni-shi, Shizuoka, Japan
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Shizuoka-shi, Shizuoka, Japan
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Tokushima
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Komatsujima-shi, Tokushima, Japan
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Tokyo
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Bunkyo-ku, Tokyo, Japan
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Chuo-Ku, Tokyo, Japan
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Wakayama
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Wakayama-shi, Wakayama, Japan
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Cheongju-si
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Chungcheongbuk-do, Cheongju-si, Korea, Republic of
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Gangwon-do
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Wonju-si, Gangwon-do, Korea, Republic of
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Gyeongsangnam-do
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Jinju, Gyeongsangnam-do, Korea, Republic of
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Jeollabuk-do
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Jeonju-si, Jeollabuk-do, Korea, Republic of
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Jung-gu
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Daejeon, Jung-gu, Korea, Republic of
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Nam-gu
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Daegu, Nam-gu, Korea, Republic of
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Seo-gu
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Busan, Seo-gu, Korea, Republic of
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South Jeolla
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Gwangju, South Jeolla, Korea, Republic of
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Sudogwon
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Seoul, Sudogwon, Korea, Republic of
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Chihuahua, Mexico
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Oaxaca, Mexico
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Puebla, Mexico
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San Luis Potosi, Mexico
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Baja California
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Tijuana, Baja California, Mexico
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Coahuila
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Torreon, Coahuila, Mexico
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Distrito Federal
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Ciudad de Mexico, Distrito Federal, Mexico
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Estado De Mexico
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Toluca, Estado De Mexico, Mexico
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Jalisco
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Guadalajara, Jalisco, Mexico
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Queretaro De Arteaga
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Queretaro, Queretaro De Arteaga, Mexico
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Amsterdam, Netherlands
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Arnhem, Netherlands
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Blaricum, Netherlands
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Delft, Netherlands
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Den Haag, Netherlands
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Doetinchem, Netherlands
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Ede, Netherlands
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Groningen, Netherlands
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Haarlem, Netherlands
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Hardenberg, Netherlands
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Heerlen, Netherlands
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Hoofddorp, Netherlands
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Hoogeveen, Netherlands
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IJssel, Netherlands
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Meppel, Netherlands
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Sittard-Geleen, Netherlands
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Zutphen, Netherlands
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Fredrikstad, Norway
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Oslo, Norway
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Stavanger, Norway
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Braga, Portugal
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Canelas, Portugal
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Faro, Portugal
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Lisboa, Portugal
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Porto, Portugal
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Senhora da Hora, Portugal
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Setubal, Portugal
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Viana do Castelo, Portugal
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Arad, Romania
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Braila, Romania
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Bucuresti, Romania
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Cluj Napoca, Romania
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Craiova, Romania
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Drobeta - Turnu Severin, Romania
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Focsani, Romania
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Pitesti, Romania
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Sibiu, Romania
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Slatina, Romania
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Timisoara, Romania
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Alicante, Spain
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Almeria, Spain
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Granada, Spain
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Lleida, Spain
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Madrid, Spain
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Murcia, Spain
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Andalusia
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Sevilla, Andalusia, Spain
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Balearic Islands
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Palma de Mallorca, Balearic Islands, Spain
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Castile-La Mancha
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Toledo, Castile-La Mancha, Spain
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Catalonia
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Barcelona, Catalonia, Spain
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Vic, Catalonia, Spain
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Extremadura
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Caceres, Extremadura, Spain
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Galicia
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Santiago de Compostela, Galicia, Spain
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Granada
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Baza, Granada, Spain
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Ankara, Turkey
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Aydin, Turkey
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Diyarbak?r, Turkey
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Istanbul, Turkey
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Merkez, Turkey
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Mersin, Turkey
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Airdrie, United Kingdom
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Cambridge, United Kingdom
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East Kilbride, United Kingdom
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London, United Kingdom
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Portadown, United Kingdom
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Sheffield, United Kingdom
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Taunton, United Kingdom
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Wolverhampton, United Kingdom
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Alabama
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Huntsville, Alabama, United States
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California
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Los Angeles, California, United States
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Santa Ana, California, United States
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Torrance, California, United States
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Ventura, California, United States
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Florida
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Clearwater, Florida, United States
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Miami, Florida, United States
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Tallahassee, Florida, United States
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Georgia
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Tucker, Georgia, United States
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Illinois
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Arlington Heights, Illinois, United States
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Englewood, Illinois, United States
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Indiana
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Lebanon, Indiana, United States
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Maine
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Auburn, Maine, United States
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Bangor, Maine, United States
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Maryland
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Columbia, Maryland, United States
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Michigan
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Jackson, Michigan, United States
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Minnesota
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Minneapolis, Minnesota, United States
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New York
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Manhasset, New York, United States
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North Carolina
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Chapel Hill, North Carolina, United States
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Durham, North Carolina, United States
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Ohio
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Sandusky, Ohio, United States
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Pennsylvania
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Abington, Pennsylvania, United States
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Doylestown, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Sayre, Pennsylvania, United States
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Rhode Island
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Providence, Rhode Island, United States
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Tennessee
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Jackson, Tennessee, United States
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Texas
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Houston, Texas, United States
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Plano, Texas, United States
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Vermont
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Burlington, Vermont, United States
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Virginia
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Falls Church, Virginia, United States
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Manassas, Virginia, United States
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Washington
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Seattle, Washington, United States
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Spokane, Washington, United States
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Carabobo
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Valencia, Carabobo, Venezuela
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Miranda
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Caracas, Miranda, Venezuela
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
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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
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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
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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.
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in a 3-year follow-up period
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Healthcare resource utilization
Time Frame: in a 3-year follow-up period
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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.
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in a 3-year follow-up period
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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.
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in a 3-year follow-up period
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Bleeding events which require medical attention
Time Frame: in a 3 year follow-up period
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To describe the rate of bleeding events requiring medical attention.
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in a 3 year follow-up period
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Collaborators and Investigators
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
General Publications
- Bagai A, Ali FM, Gregson J, Alexander KP, Cohen MG, Sundell KA, Simon T, Westermann D, Yasuda S, Brieger D, Goodman SG, Nicolau JC, Granger CB, Pocock S. Multimorbidity, functional impairment, and mortality in older patients stable after prior acute myocardial infarction: Insights from the TIGRIS registry. Clin Cardiol. 2022 Nov 1. doi: 10.1002/clc.23915. Online ahead of print.
- Carnicelli AP, Owen R, Pocock SJ, Brieger DB, Yasuda S, Nicolau JC, Goodman SG, Cohen MG, Simon T, Westermann D, Hedman K, Andersson Sundell K, Granger CB. Atrial fibrillation and clinical outcomes 1 to 3 years after myocardial infarction. Open Heart. 2021 Dec;8(2):e001726. doi: 10.1136/openhrt-2021-001726.
- Russo JJ, Yan AT, Pocock SJ, Brieger D, Owen R, Sundell KA, Bagai A, Granger CB, Cohen MG, Yasuda S, Nicolau JC, Brandrup-Wognsen G, Westermann D, Simon T, Goodman SG. Determinants of long-term dual antiplatelet therapy use in post myocardial infarction patients: Insights from the TIGRIS registry. J Cardiol. 2022 Apr;79(4):522-529. doi: 10.1016/j.jjcc.2021.10.024. Epub 2021 Nov 29.
- Pocock S, Brieger DB, Owen R, Chen J, Cohen MG, Goodman S, Granger CB, Nicolau JC, Simon T, Westermann D, Yasuda S, Hedman K, Mellstrom C, Andersson Sundell K, Grieve R. Health-related quality of life 1-3 years post-myocardial infarction: its impact on prognosis. Open Heart. 2021 Feb;8(1):e001499. doi: 10.1136/openhrt-2020-001499.
- Nicolau JC, Brieger D, Owen R, Furtado RHM, Goodman SG, Cohen MG, Simon T, Westermann D, Granger CB, Grieve R, Yasuda S, Chen J, Hedman K, Mellstrom C, Brandrup-Wognsen G, Pocock SJ. Diabetes association with self-reported health, resource utilization, and prognosis post-myocardial infarction. Clin Cardiol. 2020 Dec;43(12):1352-1361. doi: 10.1002/clc.23476. Epub 2020 Nov 4.
- Westermann D, Goodman SG, Nicolau JC, Requena G, Maguire A, Chen JY, Granger CB, Grieve R, Pocock SJ, Blankenberg S, Vega AM, Yasuda S, Simon T, Brieger D; TIGRIS Study Investigators. Rationale and design of the long-Term rIsk, clinical manaGement, and healthcare Resource utilization of stable coronary artery dISease in post-myocardial infarction patients (TIGRIS) study. Clin Cardiol. 2017 Dec;40(12):1197-1204. doi: 10.1002/clc.22837. Epub 2017 Dec 16.
- Goodman SG, Nicolau JC, Requena G, Maguire A, Blankenberg S, Chen JY, Granger CB, Grieve R, Pocock SJ, Simon T, Yasuda S, Vega AM, Brieger D; TIGRIS Study Investigators. Longer-term oral antiplatelet use in stable post-myocardial infarction patients: Insights from the long Term rIsk, clinical manaGement and healthcare Resource utilization of stable coronary artery dISease (TIGRIS) observational study. Int J Cardiol. 2017 Jun 1;236:54-60. doi: 10.1016/j.ijcard.2017.02.062. Epub 2017 Feb 21.
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- NIS-CMC-DUM-2013/1
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