Stable Coronary Artery Disease (CAD), Myocardial Infarction Clinical Trial
— TIGRISOfficial title:
TIGRIS: Long-Term rIsk, Clinical manaGement and Healthcare Resource Utilization of Stable Coronary Artery dISease in Post Myocardial Infarction Patients
| Verified date | August 2018 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Terminated |
| Enrollment | 9284 |
| Est. completion date | March 31, 2017 |
| Est. primary completion date | March 31, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 50 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Research Site | 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 | |
| Australia | Research Site | Brisbane | Queensland |
| Australia | Research Site | Coffs Harbour | New South Wales |
| Australia | Research Site | Concord | New South Wales |
| Australia | Research Site | Epping | Victoria |
| Australia | Research Site | Fremantle | Western Australia |
| Australia | Research Site | Kogarh | New South Wales |
| Australia | Research Site | Liverpool | New South Wales |
| Australia | Research Site | Nambour | Queensland |
| Australia | Research Site | Nedlands | Western Australia |
| Australia | Research Site | Newcastele | New South Wales |
| Australia | Research Site | Parkville | Victoria |
| Australia | Research Site | Richmond | Victoria |
| Australia | Research Site | Southport | Queensland |
| Australia | Research Site | St Leonards | New South Wales |
| Australia | Research Site | Wollongong | New South Wales |
| Australia | Research Site | Woolloongabba | Queensland |
| Belgium | 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 | |
| Brazil | Research Site | Blumenal | Santa Cantarina |
| Brazil | Research Site | Campo Grande | Mato Grosso Do Sul |
| Brazil | Research Site | Marilia | Sao Paulo |
| Brazil | Research Site | Sao Jose do Rio Preto | Sao Paulo |
| Canada | Research Site | Brampton | Ontario |
| Canada | Research Site | Cambridge | Ontario |
| Canada | Research Site | Greenfield Park | Quebec |
| Canada | Research Site | Hamilton | Ontario |
| Canada | Research Site | London | Ontario |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | Newmarket | Ontario |
| Canada | Research Site | North York | Ontario |
| Canada | Research Site | Quebec | |
| Canada | Research Site | Saint John | New Brunswick |
| Canada | Research Site | Saint-Jerome | Quebec |
| Canada | Research Site | Thetford Mines | Quebec |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | Windsor | Ontario |
| China | Research Site | Beijing | Beijing |
| China | Research Site | Changchun | Jilin |
| China | Research Site | Chongqing | Chongqing |
| China | Research Site | Guangzhou | Guangdong |
| China | Research Site | Jinan | Shandong |
| China | Research Site | Jinzhou | Liaoning |
| China | Research Site | Kunming | Yunnan |
| China | Research Site | Lanzhou | Gansu |
| China | Research Site | Nanjing | Jiangsu |
| China | Research Site | Shanghai | Shanghai |
| China | Research Site | Taiyuan | Shanyuan |
| China | Research Site | Tianjin | Tianjin |
| China | Research Site | Wuxi | Jiangsu |
| China | Research Site | Xian | Shanxi |
| China | Research Site | Zhenjiang | Jiangsu |
| Colombia | Research Site | Barranquilla | Atlantico |
| Colombia | Research Site | Bucaramanga | Santander Dept |
| Colombia | Research Site | Cali | Valle Del Cauca |
| Colombia | Research Site | Cartagena | Caldas |
| Colombia | Research Site | Manizales | Caldas |
| Colombia | Research Site | Medellin | Antioquia |
| Denmark | Research Site | Alborg | |
| Denmark | Research Site | arhus N | |
| 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 | |
| Finland | Research Site | Jyvaskyla | |
| Finland | Research Site | Rovaniemi | |
| Finland | Research Site | Tampere | |
| Finland | Research Site | Turku | |
| France | 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 | |
| Germany | 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 | |
| India | Research Site | Bangalore | Karnataka |
| India | Research Site | Chennai | Tamil Nadu |
| India | Research Site | Hyderabad | Andhra Pradesh |
| India | Research Site | Indore | Madhya Pradesh |
| India | Research Site | Jaipur | Rajasthan |
| India | Research Site | Kolkata | West Bengal |
| India | Research Site | Madurai | Tamil Nadu |
| India | Research Site | Mohali | Punjab |
| India | Research Site | Mumbai | Maharashtra |
| India | Research Site | New Delhi | Delhi |
| India | Research Site | Noida | Uttar Pradesh |
| India | Research Site | Pune | Maharashtra |
| India | Research Site | Surat | Gujarat |
| India | Research Site | Thrisur | Kerala |
| India | Research Site | Trivandrum | Kerala |
| Italy | 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 | |
| Japan | Research Site | Amagasaki-shi | Hyogo |
| Japan | Research Site | Bunkyo-ku | Tokyo |
| Japan | Research Site | Chiba-shi | Chiba |
| Japan | Research Site | Chuo-Ku | Tokyo |
| Japan | Research Site | Fukui-shi | Fukui |
| Japan | Research Site | Fukuoka-shi | Fukuoka |
| Japan | Research Site | Hirakata-shi | Osaka |
| Japan | Research Site | Hiroshima-shi | Hiroshima |
| Japan | Research Site | Isehara-shi | Kanagawa |
| Japan | Research Site | Izunokuni-shi | Shizuoka |
| Japan | Research Site | Kanazawa-shi | Ishikawa |
| Japan | Research Site | Kisarazu-shi | Chiba |
| Japan | Research Site | Komatsujima-shi | Tokushima |
| Japan | Research Site | Kouchi-shi | Kouchi |
| Japan | Research Site | Kumamoto-shi | Kumamoto |
| Japan | Research Site | Kurume-shi | Fukuoka |
| Japan | Research Site | Kusatsu-shi | Shiga |
| Japan | Research Site | Maebashi-shi | Gunma |
| Japan | Research Site | Matsuyama-shi | Ehime |
| Japan | Research Site | Morioka-shi | Iwate |
| Japan | Research Site | Osaka-shi | Osaka |
| Japan | Research Site | Sagamihara-shi | Kanagawa |
| Japan | Research Site | Sapporo-shi | Hokkaido |
| Japan | Research Site | Sendai-shi | Miyagi |
| Japan | Research Site | Shizuoka-shi | Shizuoka |
| Japan | Research Site | Suita-shi | Osaka |
| Japan | Research Site | Tenri-shi | Nara |
| Japan | Research Site | Tomakomai-shi | Hokkaido |
| Japan | Research Site | Toyoake-shi | Aichi |
| Japan | Research Site | Wakayama-shi | Wakayama |
| Japan | Research Site | Yokohama-shi | Kanagawa |
| Korea, Republic of | Research Site | Busan | Seo-gu |
| Korea, Republic of | Research Site | Chungcheongbuk-do | Cheongju-si |
| Korea, Republic of | Research Site | Daegu | Nam-gu |
| Korea, Republic of | Research Site | Daejeon | Jung-gu |
| Korea, Republic of | Research Site | Gwangju | South Jeolla |
| Korea, Republic of | Research Site | Jeonju-si | Jeollabuk-do |
| Korea, Republic of | Research Site | Jinju | Gyeongsangnam-do |
| Korea, Republic of | Research Site | Seoul | Sudogwon |
| Korea, Republic of | Research Site | Wonju-si | Gangwon-do |
| Mexico | Research Site | Chihuahua | |
| Mexico | Research Site | Ciudad de Mexico | Distrito Federal |
| Mexico | Research Site | Guadalajara | Jalisco |
| Mexico | Research Site | Oaxaca | |
| Mexico | Research Site | Puebla | |
| Mexico | Research Site | Queretaro | Queretaro De Arteaga |
| Mexico | Research Site | San Luis Potosi | |
| Mexico | Research Site | Tijuana | Baja California |
| Mexico | Research Site | Toluca | Estado De Mexico |
| Mexico | Research Site | Torreon | Coahuila |
| Netherlands | 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 | |
| Norway | Research Site | Fredrikstad | |
| Norway | Research Site | Oslo | |
| Norway | Research Site | Stavanger | |
| Portugal | 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 | |
| Romania | 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 | |
| Spain | Research Site | Alicante | |
| Spain | Research Site | Almeria | |
| Spain | Research Site | Barcelona | Catalonia |
| Spain | Research Site | Baza | Granada |
| Spain | Research Site | Caceres | Extremadura |
| Spain | Research Site | Granada | |
| Spain | Research Site | Lleida | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Murcia | |
| Spain | Research Site | Palma de Mallorca | Balearic Islands |
| Spain | Research Site | Santiago de Compostela | Galicia |
| Spain | Research Site | Sevilla | Andalusia |
| Spain | Research Site | Toledo | Castile-La Mancha |
| Spain | Research Site | Vic | Catalonia |
| Turkey | Research Site | Ankara | |
| Turkey | Research Site | Aydin | |
| Turkey | Research Site | Diyarbak?r | |
| Turkey | Research Site | Istanbul | |
| Turkey | Research Site | Merkez | |
| Turkey | Research Site | Mersin | |
| United Kingdom | 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 States | Research Site | Abington | Pennsylvania |
| United States | Research Site | Arlington Heights | Illinois |
| United States | Research Site | Auburn | Maine |
| United States | Research Site | Bangor | Maine |
| United States | Research Site | Burlington | Vermont |
| United States | Research Site | Chapel Hill | North Carolina |
| United States | Research Site | Clearwater | Florida |
| United States | Research Site | Columbia | Maryland |
| United States | Research Site | Doylestown | Pennsylvania |
| United States | Research Site | Durham | North Carolina |
| United States | Research Site | Englewood | Illinois |
| United States | Research Site | Falls Church | Virginia |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Huntsville | Alabama |
| United States | Research Site | Jackson | Michigan |
| United States | Research Site | Jackson | Tennessee |
| United States | Research Site | Lebanon | Indiana |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Manassas | Virginia |
| United States | Research Site | Manhasset | New York |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Minneapolis | Minnesota |
| United States | Research Site | Pittsburgh | Pennsylvania |
| United States | Research Site | Plano | Texas |
| United States | Research Site | Providence | Rhode Island |
| United States | Research Site | Sandusky | Ohio |
| United States | Research Site | Santa Ana | California |
| United States | Research Site | Sayre | Pennsylvania |
| United States | Research Site | Seattle | Washington |
| United States | Research Site | Spokane | Washington |
| United States | Research Site | Tallahassee | Florida |
| United States | Research Site | Torrance | California |
| United States | Research Site | Tucker | Georgia |
| United States | Research Site | Ventura | California |
| Venezuela | Research Site | Caracas | Miranda |
| Venezuela | Research Site | Valencia | Carabobo |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Venezuela, Argentina, Australia, Belgium, Brazil, Canada, China, Colombia, Denmark, Finland, France, Germany, India, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Norway, Portugal, Romania, Spain, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | MI, unstable angina with urgent revascularization, stroke, and death for any cause | 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 | |
| Primary | Healthcare resource utilization | 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 | Ischemic events (MI, unstable angina with urgent revascularization, ischemic stroke, CV death or death with unknown reason) | 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 | |
| Secondary | Bleeding events which require medical attention | To describe the rate of bleeding events requiring medical attention. | in a 3 year follow-up period |