Stable Coronary Artery Disease (CAD), Myocardial InfarctionTIGRISNCT01866904

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

An observational study of Stable Coronary Artery Disease (CAD), Myocardial Infarction, run by AstraZeneca at 309 sites in 25 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Stable Coronary Artery Disease (CAD), Myocardial Infarction
How many people: 9,284 participants
Where: 309 sitesin 25 countries
Study dates: 19 Jun 2013to 31 Mar 2017
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

309 sites in 25 countries.

Country

City, postcode or hospital

309 sites in 25 countries

United States34 sites

Research Site
Abington, Pennsylvania
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Arlington Heights, Illinois
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Auburn, Maine
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Bangor, Maine
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Burlington, Vermont
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Chapel Hill, North Carolina
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Clearwater, Florida
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Columbia, Maryland
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Doylestown, Pennsylvania
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Durham, North Carolina
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Englewood, Illinois
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Falls Church, Virginia
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Houston, Texas
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Huntsville, Alabama
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Jackson, Michigan
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Jackson, Tennessee
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Lebanon, Indiana
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Los Angeles, California
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Manassas, Virginia
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Manhasset, New York
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Miami, Florida
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Minneapolis, Minnesota
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Pittsburgh, Pennsylvania
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Plano, Texas
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Providence, Rhode Island
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Sandusky, Ohio
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Santa Ana, California
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Sayre, Pennsylvania
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Seattle, Washington
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Spokane, Washington
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Tallahassee, Florida
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Torrance, California
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Tucker, Georgia
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Ventura, California

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Japan31 sites

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Amagasaki-shi, Hyōgo
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Bunkyo-ku, Tokyo
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Chiba, Chiba
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Chuo-Ku, Tokyo
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Fukui-shi, Fukui
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Fukuoka, Fukuoka
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Hirakata-shi, Osaka
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Hiroshima, Hiroshima
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Isehara-shi, Kanagawa
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Izunokuni-shi, Shizuoka
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Kanazawa, Ishikawa-ken
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Kisarazu-shi, Chiba
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Kochi, Kochi
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Komatsujima-shi, Tokushima
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Kumamoto, Kumamoto
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Kurume-shi, Fukuoka
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Kusatsu-shi, Shiga
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Maebashi, Gunma
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Matsuyama, Ehime
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Morioka, Iwate
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Osaka, Osaka
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Sagamihara-shi, Kanagawa
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Sapporo, Hokkaido
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Sendai, Miyagi
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Shizuoka, Shizuoka
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Suita-shi, Osaka
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Tenri-shi, Nara
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Tomakomai-shi, Hokkaido
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Toyoake-shi, Aichi-ken
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Wakayama, Wakayama
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Yokohama, Kanagawa

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Germany28 sites

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Berlin
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Bochum
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Chemnitz
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Cloppenburg
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Coburg
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Cologne
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Dresden
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Erfurt
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Erlangen
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Essen
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Frankfurt
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Frankfurt M
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Hamburg
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Heidelberg
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Kiel
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Koblenz
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Leipzig
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Leverkusen
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Lübeck
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Ludwigshafen
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Mainz
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Merseburg
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Mönchengladbach
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München
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Potsdam
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Soltau
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Stuttgart
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Ulm

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Netherlands17 sites

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Amsterdam
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Arnhem
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Blaricum
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Delft
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Doetinchem
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Ede
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Groningen
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Haarlem
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Hardenberg
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Heerlen
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Hoofddorp
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Hoogeveen
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IJssel
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Meppel
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Sittard-Geleen
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The Hague
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Zutphen

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Australia16 sites

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Brisbane, Queensland
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Coffs Harbour, New South Wales
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Concord, New South Wales
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Epping, Victoria
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Fremantle, Western Australia
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Kogarh, New South Wales
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Liverpool, New South Wales
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Nambour, Queensland
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Nedlands, Western Australia
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Newcastele, New South Wales
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Parkville, Victoria
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Richmond, Victoria
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Southport, Queensland
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St Leonards, New South Wales
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Wollongong, New South Wales
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Woolloongabba, Queensland

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France16 sites

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Abbeville
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Arras
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Boulogne-Billancourt
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Briis Sous Forge
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Corbeille Essone
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Dijon
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La Rochelle
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Langres
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Le Chesnay
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Le Coudray
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Lyon
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Marseille
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Nice
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Roubaix
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Salouël
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Toulouse

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China15 sites

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Beijing, Beijing Municipality
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Changchun, Jilin
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Chongqing, Chongqing Municipality
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Guangzhou, Guangdong
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Jinan, Shandong
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Jinzhou, Liaoning
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Kunming, Yunnan
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Lanzhou, Gansu
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Nanjing, Jiangsu
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Shanghai, Shanghai Municipality
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Taiyuan, Shanyuan
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Tianjin, Tianjin Municipality
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Wuxi, Jiangsu
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Xian, Shanxi
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Zhenjiang, Jiangsu

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India15 sites

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Bangalore, Karnataka
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Chennai, Tamil Nadu
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Hyderabad, Andhra Pradesh
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Indore, Madhya Pradesh
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Jaipur, Rajasthan
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Kolkata, West Bengal
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Madurai, Tamil Nadu
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Mohali, Punjab
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Mumbai, Maharashtra
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New Delhi, National Capital Territory of Delhi
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Noida, Uttar Pradesh
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Pune, Maharashtra
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Surat, Gujarat
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Thrisur, Kerala
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Trivandrum, Kerala

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Canada14 sites

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Brampton, Ontario
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Cambridge, Ontario
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Greenfield Park, Quebec
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Hamilton, Ontario
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London, Ontario
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Montreal, Quebec
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Newmarket, Ontario
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North York, Ontario
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Québec
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Saint John, New Brunswick
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Saint-Jérôme, Quebec
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Thetford-Mines, Quebec
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Toronto, Ontario
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Windsor, Ontario

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Italy14 sites

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Ancona
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Bologna
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Catania
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Lagosanto FE
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Lido di Camaiore
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Massa Carrara
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Milan
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Naples
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Nuoro
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Palermo
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Perugia
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Prato
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Sassari
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Treviso

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Spain14 sites

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Alicante
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Almería
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Barcelona, Catalonia
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Baza, Granada
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Cáceres, Extremadura
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Granada
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Lleida
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Madrid
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Murcia
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Palma de Mallorca, Balearic Islands
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Santiago de Compostela, Galicia
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Seville, Andalusia
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Toledo, Castille-La Mancha
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Vic, Catalonia

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Romania11 sites

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Arad
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Brăila
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Bucharest
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Cluj-Napoca
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Craiova
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Drobeta-Turnu Severin
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Focşani
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Piteşti
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Sibiu
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Slatina
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Timișoara

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Belgium10 sites

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Aalst
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Bonheiden
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Brasschaat
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Brussels
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Genk
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Ghent
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Kortrijk
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Ostend
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Overpelt
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Veurne

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Mexico10 sites

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Chihuahua City
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Guadalajara, Jalisco
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Mexico City, Mexico City
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Oaxaca City
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Puebla City
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Querétaro City, Querétaro
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San Luis Potosí City
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Tijuana, Estado de Baja California
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Toluca, State of Mexico
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Torreón, Coahuila

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South Korea9 sites

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Busan, Seo-gu
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Chungcheongbuk-do, Cheongju-si
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Daegu, Nam-gu
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Daejeon, Jung-gu
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Gwangju, Jeollanam-do
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Jeonju, Jeollabuk-do
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Jinju, Gyeongsangnam-do
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Seoul, Sudogwon
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Wŏnju, Gangwon-do

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Denmark8 sites

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Aalborg
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Arhus N
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Copenhagen
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Haderslev
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Hellerup
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København NV
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København S
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Randers

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Portugal8 sites

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Braga
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Canelas
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Faro
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Lisbon
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Porto
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Senhora da Hora
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Setúbal
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Viana do Castelo

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United Kingdom8 sites

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Airdrie
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Cambridge
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East Kilbride
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London
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Portadown
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Sheffield
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Taunton
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Wolverhampton

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Argentina6 sites

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Buenos Aires
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Córdoba
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Corrientes
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Mendoza
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Salta
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Santa Fe

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Colombia6 sites

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Barranquilla, Atlántico
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Bucaramanga, Santander Dept
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Cali, Valle del Cauca Department
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Cartagena, Caldas Department
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Manizales, Caldas Department
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Medellín, Antioquia

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Turkey (Türkiye)6 sites

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Ankara
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Aydin
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Center
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Istanbul
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Mersin

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Brazil4 sites

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Blumenal, Santa Cantarina
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Marília, São Paulo
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Finland4 sites

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Jyväskylä
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Rovaniemi
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Tampere
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Turku

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Norway3 sites

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Fredrikstad
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Oslo
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Stavanger

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Venezuela2 sites

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Caracas, Miranda
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Valencia, Carabobo

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About this study

Official title: TIGRIS: Long-Term rIsk, Clinical manaGement and Healthcare Resource Utilization of Stable Coronary Artery dISease in Post Myocardial Infarction Patients

Read the 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.

Conditions: Stable Coronary Artery Disease (CAD), Myocardial Infarction
Keywords: Coronary artery disease, Myocardial infarction
Medical subject headings: Myocardial Infarction, Coronary Artery Disease, Autosomal Dominant, 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01866904
Study group	Role	What they receive
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 being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: in a 3-year follow-up period
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.
Measured: in a 3-year follow-up period

Secondary outcomes (2)

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.
Measured: in a 3-year follow-up period
Bleeding events which require medical attention
To describe the rate of bleeding events requiring medical attention.
Measured: in a 3 year follow-up period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Jun 201331 Mar 2017

First posted3 Jun 2013 (estimated)
Study start19 Jun 2013
Primary completion31 Mar 2017
Study completion31 Mar 2017

Why it stopped: Study was terminated in order to secure the data quality of the study in terms of follow-up rates and data completeness.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Stable Coronary Artery Disease (CAD), Myocardial InfarctionStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 9,284 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01866904
Sponsor's protocol ID: NIS-CMC-DUM-2013/1
Acronym: TIGRIS
Status last verified: Aug 2018
First submitted: 29 May 2013
Last updated: 4 Sep 2018
Results posted: No
Data monitoring committee: No

Publications

Krishnamurthy SN, Pocock S, Kaul P, Owen R, Goodman SG, Granger CB, Nicolau JC, Simon T, Westermann D, Yasuda S, Andersson K, Brandrup-Wognsen G, Hunt PR, Brieger DB, Cohen MG. Comparing the long-term outcomes in chronic coronary syndrome patients with prior ST-segment and non-ST-segment elevation myocardial infarction: findings from the TIGRIS registry. BMJ Open. 2023 Dec 18;13(12):e070237. doi: 10.1136/bmjopen-2022-070237.
PubMed 38110389
Nicolau JC, Owen R, Furtado RHM, Goodman SG, Granger CB, Cohen MG, Westermann D, Yasuda S, Simon T, Hedman K, Hunt PR, Brieger DB, Pocock SJ. Long-term outcomes among stable post-acute myocardial infarction patients living in rural versus urban areas: insights from the prospective, observational TIGRIS registry. Open Heart. 2023 Aug;10(2):e002326. doi: 10.1136/openhrt-2023-002326.
PubMed 37604649
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 Dec;45(12):1277-1286. doi: 10.1002/clc.23915. Epub 2022 Nov 1.
PubMed 36317424
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.
PubMed 34911791
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.
PubMed 34857432
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.
PubMed 33563776
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.
PubMed 33146924
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.
PubMed 29247524
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.
PubMed 28268087

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: TIGRIS: Long-Term rIsk, Clinical manaGement and Healthcare Resource Utilization of Stable Coronary Artery dISease in Post Myocardial Infarction Patients
ClinicalTrials.gov ID: NCT01866904
Acronym / sponsor ID: TIGRIS / NIS-CMC-DUM-2013/1
Conditions: Stable Coronary Artery Disease (CAD), Myocardial Infarction
Keywords: Coronary artery disease, Myocardial infarction
Study type: Observational
Recruitment status: TerminatedReason stopped: Study was terminated in order to secure the data quality of the study in terms of follow-up rates and data completeness.
Enrolment: 9,284 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 19 Jun 2013 (actual)
Primary completion: 31 Mar 2017 (actual)
Study completion: 31 Mar 2017 (actual)
First posted: 3 Jun 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
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

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.
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.

2 secondary outcomes

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
Bleeding events which require medical attention
Time frame: in a 3 year follow-up period

Results and safety

The study was stopped early (reason given: Study was terminated in order to secure the data quality of the study in terms of follow-up rates and data completeness.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2018.
Derived from this study: PubMed 38110389Krishnamurthy SN, Pocock S, Kaul P, Owen R, Goodman SG, Granger CB, Nicolau JC, Simon T, Westermann D, Yasuda S, Andersson K, Brandrup-Wognsen G, Hunt PR, Brieger DB, Cohen MG. Comparing the long-term outcomes in chronic coronary syndrome patients with prior ST-segment and non-ST-segment elevation myocardial infarction: findings from the TIGRIS registry. BMJ Open. 2023 Dec 18;13(12):e070237. doi: 10.1136/bmjopen-2022-070237.
Derived from this study: PubMed 37604649Nicolau JC, Owen R, Furtado RHM, Goodman SG, Granger CB, Cohen MG, Westermann D, Yasuda S, Simon T, Hedman K, Hunt PR, Brieger DB, Pocock SJ. Long-term outcomes among stable post-acute myocardial infarction patients living in rural versus urban areas: insights from the prospective, observational TIGRIS registry. Open Heart. 2023 Aug;10(2):e002326. doi: 10.1136/openhrt-2023-002326.
Derived from this study: PubMed 36317424Bagai 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 Dec;45(12):1277-1286. doi: 10.1002/clc.23915. Epub 2022 Nov 1.
Derived from this study: PubMed 34911791Carnicelli 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.
Derived from this study: PubMed 34857432Russo 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.
Derived from this study: PubMed 33563776Pocock 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.
Derived from this study: PubMed 33146924Nicolau 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.
Derived from this study: PubMed 29247524Westermann 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.
Derived from this study: PubMed 28268087Goodman 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.
CSR SynopsisLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lin Zhang, M.D., PhD study chair

AstraZeneca GMA

David Brieger, MBBS, PhD principal investigator

Concord Repatriation General Hospital

309 sites in 25 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Stable Coronary Artery Disease (CAD), Myocardial Infarction, run by AstraZeneca at 309 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 309 sites in United States, Japan, Germany, Netherlands, Australia and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MI, unstable angina with urgent revascularization, stroke, and death for any cause (time frame: in a 3-year follow-up period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01866904, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2018.