Clinical trial NCT01866904: Long-Term rIsk, Clinical manaGement and Healthcare Resource Utilization of Stable CAD in Post MI Patients
Official title: TIGRIS: Long-Term rIsk, Clinical manaGement and Healthcare Resource Utilization of Stable Coronary Artery dISease in Post Myocardial Infarction Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Stable Coronary Artery Disease (CAD), Myocardial Infarction
Keywords: Coronary artery disease, Myocardial infarction
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-06-03
Enrollment: 9284
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Stable CAD patients aged 50 years or older with documented history of presumed spontaneous MI with their most recent MI occurring 1 to 3 years prior to enrollment and at least one additional risk factor for atherothrombotic events

Brief summary: THis study is intended to provide contemporary data on the burden of disease in patients 1 to 3 years post-MI, including a description of patient characteristics, current treatment patterns, rate of major CV events, and healthcare resource utilization in a 'real world' patient population at high atherothrombotic risk.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: MI, unstable angina with urgent revascularization, stroke, and death for any cause
timeFrame: in a 3-year follow-up period
measure: Healthcare resource utilization
timeFrame: in a 3-year follow-up period
Secondary outcomes:
measure: Ischemic events (MI, unstable angina with urgent revascularization, ischemic stroke, CV death or death with unknown reason)
timeFrame: in a 3-year follow-up period
measure: Bleeding events which require medical attention
timeFrame: in a 3 year follow-up period
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Research Site
state: Alabama
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Santa Ana
country: United States
facility: Research Site
state: California
city: Torrance
country: United States
facility: Research Site
state: California
city: Ventura
country: United States
facility: Research Site
state: California
city: Clearwater
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Tallahassee
country: United States
facility: Research Site
state: Florida
city: Tucker
country: United States
facility: Research Site
state: Georgia
city: Arlington Heights
country: United States
facility: Research Site
state: Illinois
city: Englewood
country: United States
facility: Research Site
state: Illinois
city: Lebanon
country: United States
facility: Research Site
state: Indiana
city: Auburn
country: United States
facility: Research Site
state: Maine
city: Bangor
country: United States
facility: Research Site
state: Maine
city: Columbia
country: United States
facility: Research Site
state: Maryland
city: Jackson
country: United States
facility: Research Site
state: Michigan
city: Minneapolis
country: United States
facility: Research Site
state: Minnesota
city: Manhasset
country: United States
facility: Research Site
state: New York
city: Chapel Hill
country: United States
facility: Research Site
state: North Carolina
city: Durham
country: United States
facility: Research Site
state: North Carolina
city: Sandusky
country: United States
facility: Research Site
state: Ohio
city: Abington
country: United States
facility: Research Site
state: Pennsylvania
city: Doylestown
country: United States
facility: Research Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Sayre
country: United States
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state: Pennsylvania
city: Providence
country: United States
facility: Research Site
state: Rhode Island
city: Jackson
country: United States
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state: Tennessee
city: Houston
country: United States
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state: Texas
city: Plano
country: United States
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state: Texas
city: Burlington
country: United States
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state: Vermont
city: Falls Church
country: United States
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state: Virginia
city: Manassas
country: United States
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state: Virginia
city: Seattle
country: United States
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state: Washington
city: Spokane
country: United States
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state: Washington
city: Buenos Aires
country: Argentina
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city: Cordoba
country: Argentina
facility: Research Site
city: Corrientes
country: Argentina
facility: Research Site
city: Mendoza
country: Argentina
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city: Salta
country: Argentina
facility: Research Site
city: Santa Fe de la Vera Cruz
country: Argentina
facility: Research Site
city: Coffs Harbour
country: Australia
facility: Research Site
state: New South Wales
city: Concord
country: Australia
facility: Research Site
state: New South Wales
city: Kogarh
country: Australia
facility: Research Site
state: New South Wales
city: Liverpool
country: Australia
facility: Research Site
state: New South Wales
city: Newcastele
country: Australia
facility: Research Site
state: New South Wales
city: St Leonards
country: Australia
facility: Research Site
state: New South Wales
city: Wollongong
country: Australia
facility: Research Site
state: New South Wales
city: Brisbane
country: Australia
facility: Research Site
state: Queensland
city: Nambour
country: Australia
facility: Research Site
state: Queensland
city: Southport
country: Australia
facility: Research Site
state: Queensland
city: Woolloongabba
country: Australia
facility: Research Site
state: Queensland
city: Epping
country: Australia
facility: Research Site
state: Victoria
city: Parkville
country: Australia
facility: Research Site
state: Victoria
city: Richmond
country: Australia
facility: Research Site
state: Victoria
city: Fremantle
country: Australia
facility: Research Site
state: Western Australia
city: Nedlands
country: Australia
facility: Research Site
state: Western Australia
city: Aalst
country: Belgium
facility: Research Site
city: Bonheiden
country: Belgium
facility: Research Site
city: Brasschaat
country: Belgium
facility: Research Site
city: Bruxelles
country: Belgium
facility: Research Site
city: Genk
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Kortrijk
country: Belgium
facility: Research Site
city: Oostende
country: Belgium
facility: Research Site
city: Overpelt
country: Belgium
facility: Research Site
city: Veurne
country: Belgium
facility: Research Site
city: Campo Grande
country: Brazil
facility: Research Site
state: Mato Grosso Do Sul
city: Blumenal
country: Brazil
facility: Research Site
state: Santa Cantarina
city: Marilia
country: Brazil
facility: Research Site
state: Sao Paulo
city: Sao Jose do Rio Preto
country: Brazil
facility: Research Site
state: Sao Paulo
city: Saint John
country: Canada
facility: Research Site
state: New Brunswick
city: Brampton
country: Canada
facility: Research Site
state: Ontario
city: Cambridge
country: Canada
facility: Research Site
state: Ontario
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: London
country: Canada
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state: Ontario
city: Newmarket
country: Canada
facility: Research Site
state: Ontario
city: North York
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Windsor
country: Canada
facility: Research Site
state: Ontario
city: Greenfield Park
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Saint-Jerome
country: Canada
facility: Research Site
state: Quebec
city: Thetford Mines
country: Canada
facility: Research Site
state: Quebec
city: Quebec
country: Canada
facility: Research Site
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Chongqing
country: China
facility: Research Site
state: Chongqing
city: Lanzhou
country: China
facility: Research Site
state: Gansu
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Nanjing
country: China
facility: Research Site
state: Jiangsu
city: Wuxi
country: China
facility: Research Site
state: Jiangsu
city: Zhenjiang
country: China
facility: Research Site
state: Jiangsu
city: Changchun
country: China
facility: Research Site
state: Jilin
city: Jinzhou
country: China
facility: Research Site
state: Liaoning
city: Jinan
country: China
facility: Research Site
state: Shandong
city: Shanghai
country: China
facility: Research Site
state: Shanghai
city: Xian
country: China
facility: Research Site
state: Shanxi
city: Taiyuan
country: China
facility: Research Site
state: Shanyuan
city: Tianjin
country: China
facility: Research Site
state: Tianjin
city: Kunming
country: China
facility: Research Site
state: Yunnan
city: Medellin
country: Colombia
facility: Research Site
state: Antioquia
city: Barranquilla
country: Colombia
facility: Research Site
state: Atlantico
city: Cartagena
country: Colombia
facility: Research Site
state: Caldas
city: Manizales
country: Colombia
facility: Research Site
state: Caldas
city: Bucaramanga
country: Colombia
facility: Research Site
state: Santander Dept
city: Cali
country: Colombia
facility: Research Site
state: Valle Del Cauca
city: Alborg
country: Denmark
facility: Research Site
city: arhus N
country: Denmark
facility: Research Site
city: Haderslev
country: Denmark
facility: Research Site
city: Hellerup
country: Denmark
facility: Research Site
city: Kobenhavn NV
country: Denmark
facility: Research Site
city: Kobenhavn S
country: Denmark
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city: Kobenhavn
country: Denmark
facility: Research Site
city: Randers
country: Denmark
facility: Research Site
city: Jyvaskyla
country: Finland
facility: Research Site
city: Rovaniemi
country: Finland
facility: Research Site
city: Tampere
country: Finland
facility: Research Site
city: Turku
country: Finland
facility: Research Site
city: Abbeville
country: France
facility: Research Site
city: Arras
country: France
facility: Research Site
city: Boulogne-Billancourt
country: France
facility: Research Site
city: Briis Sous Forge
country: France
facility: Research Site
city: Corbeille Essone
country: France
facility: Research Site
city: Dijon Cedex
country: France
facility: Research Site
city: La Rochelle
country: France
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city: Langres
country: France
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city: Le Chesnay
country: France
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city: Le Coudray
country: France
facility: Research Site
city: Lyon
country: France
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city: Marseille
country: France
facility: Research Site
city: Nice Cedex 1
country: France
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city: Roubaix
country: France
facility: Research Site
city: Salouel
country: France
facility: Research Site
city: Toulouse
country: France
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bochum
country: Germany
facility: Research Site
city: Chemnitz
country: Germany
facility: Research Site
city: Cloppenburg
country: Germany
facility: Research Site
city: Coburg
country: Germany
facility: Research Site
city: Dresden
country: Germany
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city: Erfurt
country: Germany
facility: Research Site
city: Erlangen
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Frankfurt M
country: Germany
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city: Frankfurt
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Kiel
country: Germany
facility: Research Site
city: Koblenz
country: Germany
facility: Research Site
city: Koln
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Leverkusen
country: Germany
facility: Research Site
city: Lubeck
country: Germany
facility: Research Site
city: Ludwigshafen
country: Germany
facility: Research Site
city: Mainz
country: Germany
facility: Research Site
city: Merseburg
country: Germany
facility: Research Site
city: Monchengladbach
country: Germany
facility: Research Site
city: Munchen
country: Germany
facility: Research Site
city: Potsdam
country: Germany
facility: Research Site
city: Soltau
country: Germany
facility: Research Site
city: Stuttgart
country: Germany
facility: Research Site
city: Ulm
country: Germany
facility: Research Site
city: Hyderabad
country: India
facility: Research Site
state: Andhra Pradesh
city: New Delhi
country: India
facility: Research Site
state: Delhi
city: Surat
country: India
facility: Research Site
state: Gujarat
city: Bangalore
country: India
facility: Research Site
state: Karnataka
city: Thrisur
country: India
facility: Research Site
state: Kerala
city: Trivandrum
country: India
facility: Research Site
state: Kerala
city: Indore
country: India
facility: Research Site
state: Madhya Pradesh
city: Mumbai
country: India
facility: Research Site
state: Maharashtra
city: Pune
country: India
facility: Research Site
state: Maharashtra
city: Mohali
country: India
facility: Research Site
state: Punjab
city: Jaipur
country: India
facility: Research Site
state: Rajasthan
city: Chennai
country: India
facility: Research Site
state: Tamil Nadu
city: Madurai
country: India
facility: Research Site
state: Tamil Nadu
city: Noida
country: India
facility: Research Site
state: Uttar Pradesh
city: Kolkata
country: India
facility: Research Site
state: West Bengal
city: Ancona
country: Italy
facility: Research Site
city: Bologna
country: Italy
facility: Research Site
city: Catania
country: Italy
facility: Research Site
city: Lagosanto FE
country: Italy
facility: Research Site
city: Lido di Camaiore
country: Italy
facility: Research Site
city: Massa Carrara
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Nuoro
country: Italy
facility: Research Site
city: Palermo
country: Italy
facility: Research Site
city: Perugia
country: Italy
facility: Research Site
city: Prato
country: Italy
facility: Research Site
city: Sassari
country: Italy
facility: Research Site
city: Treviso
country: Italy
facility: Research Site
city: Toyoake-shi
country: Japan
facility: Research Site
state: Aichi
city: Chiba-shi
country: Japan
facility: Research Site
state: Chiba
city: Kisarazu-shi
country: Japan
facility: Research Site
state: Chiba
city: Matsuyama-shi
country: Japan
facility: Research Site
state: Ehime
city: Fukui-shi
country: Japan
facility: Research Site
state: Fukui
city: Fukuoka-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Kurume-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Maebashi-shi
country: Japan
facility: Research Site
state: Gunma
city: Hiroshima-shi
country: Japan
facility: Research Site
state: Hiroshima
city: Sapporo-shi
country: Japan
facility: Research Site
state: Hokkaido
city: Tomakomai-shi
country: Japan
facility: Research Site
state: Hokkaido
city: Amagasaki-shi
country: Japan
facility: Research Site
state: Hyogo
city: Kanazawa-shi
country: Japan
facility: Research Site
state: Ishikawa
city: Morioka-shi
country: Japan
facility: Research Site
state: Iwate
city: Isehara-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Sagamihara-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Kouchi-shi
country: Japan
facility: Research Site
state: Kouchi
city: Kumamoto-shi
country: Japan
facility: Research Site
state: Kumamoto
city: Sendai-shi
country: Japan
facility: Research Site
state: Miyagi
city: Tenri-shi
country: Japan
facility: Research Site
state: Nara
city: Hirakata-shi
country: Japan
facility: Research Site
state: Osaka
city: Osaka-shi
country: Japan
facility: Research Site
state: Osaka
city: Suita-shi
country: Japan
facility: Research Site
state: Osaka
city: Kusatsu-shi
country: Japan
facility: Research Site
state: Shiga
city: Izunokuni-shi
country: Japan
facility: Research Site
state: Shizuoka
city: Shizuoka-shi
country: Japan
facility: Research Site
state: Shizuoka
city: Komatsujima-shi
country: Japan
facility: Research Site
state: Tokushima
city: Bunkyo-ku
country: Japan
facility: Research Site
state: Tokyo
city: Chuo-Ku
country: Japan
facility: Research Site
state: Tokyo
city: Wakayama-shi
country: Japan
facility: Research Site
state: Wakayama
city: Chungcheongbuk-do
country: Korea, Republic of
facility: Research Site
state: Cheongju-si
city: Wonju-si
country: Korea, Republic of
facility: Research Site
state: Gangwon-do
city: Jinju
country: Korea, Republic of
facility: Research Site
state: Gyeongsangnam-do
city: Jeonju-si
country: Korea, Republic of
facility: Research Site
state: Jeollabuk-do
city: Daejeon
country: Korea, Republic of
facility: Research Site
state: Jung-gu
city: Daegu
country: Korea, Republic of
facility: Research Site
state: Nam-gu
city: Busan
country: Korea, Republic of
facility: Research Site
state: Seo-gu
city: Gwangju
country: Korea, Republic of
facility: Research Site
state: South Jeolla
city: Seoul
country: Korea, Republic of
facility: Research Site
state: Sudogwon
city: Tijuana
country: Mexico
facility: Research Site
state: Baja California
city: Torreon
country: Mexico
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state: Coahuila
city: Ciudad de Mexico
country: Mexico
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state: Distrito Federal
city: Toluca
country: Mexico
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state: Estado De Mexico
city: Guadalajara
country: Mexico
facility: Research Site
state: Jalisco
city: Queretaro
country: Mexico
facility: Research Site
state: Queretaro De Arteaga
city: Chihuahua
country: Mexico
facility: Research Site
city: Oaxaca
country: Mexico
facility: Research Site
city: Puebla
country: Mexico
facility: Research Site
city: San Luis Potosi
country: Mexico
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Arnhem
country: Netherlands
facility: Research Site
city: Blaricum
country: Netherlands
facility: Research Site
city: Delft
country: Netherlands
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city: Den Haag
country: Netherlands
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city: Doetinchem
country: Netherlands
facility: Research Site
city: Ede
country: Netherlands
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city: Groningen
country: Netherlands
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city: Haarlem
country: Netherlands
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city: Hardenberg
country: Netherlands
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city: Heerlen
country: Netherlands
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city: Hoofddorp
country: Netherlands
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city: Hoogeveen
country: Netherlands
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city: IJssel
country: Netherlands
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city: Meppel
country: Netherlands
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city: Sittard-Geleen
country: Netherlands
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city: Zutphen
country: Netherlands
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city: Fredrikstad
country: Norway
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city: Oslo
country: Norway
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city: Stavanger
country: Norway
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city: Braga
country: Portugal
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city: Canelas
country: Portugal
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city: Faro
country: Portugal
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city: Lisboa
country: Portugal
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city: Porto
country: Portugal
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city: Senhora da Hora
country: Portugal
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city: Setubal
country: Portugal
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city: Viana do Castelo
country: Portugal
facility: Research Site
city: Arad
country: Romania
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city: Braila
country: Romania
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city: Bucuresti
country: Romania
facility: Research Site
city: Cluj Napoca
country: Romania
facility: Research Site
city: Craiova
country: Romania
facility: Research Site
city: Drobeta - Turnu Severin
country: Romania
facility: Research Site
city: Focsani
country: Romania
facility: Research Site
city: Pitesti
country: Romania
facility: Research Site
city: Sibiu
country: Romania
facility: Research Site
city: Slatina
country: Romania
facility: Research Site
city: Timisoara
country: Romania
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
state: Andalusia
city: Palma de Mallorca
country: Spain
facility: Research Site
state: Balearic Islands
city: Toledo
country: Spain
facility: Research Site
state: Castile-La Mancha
city: Barcelona
country: Spain
facility: Research Site
state: Catalonia
city: Vic
country: Spain
facility: Research Site
state: Catalonia
city: Caceres
country: Spain
facility: Research Site
state: Extremadura
city: Santiago de Compostela
country: Spain
facility: Research Site
state: Galicia
city: Baza
country: Spain
facility: Research Site
state: Granada
city: Alicante
country: Spain
facility: Research Site
city: Almeria
country: Spain
facility: Research Site
city: Granada
country: Spain
facility: Research Site
city: Lleida
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Murcia
country: Spain
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Aydin
country: Turkey
facility: Research Site
city: Diyarbak?r
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Merkez
country: Turkey
facility: Research Site
city: Mersin
country: Turkey
facility: Research Site
city: Airdrie
country: United Kingdom
facility: Research Site
city: Cambridge
country: United Kingdom
facility: Research Site
city: East Kilbride
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Portadown
country: United Kingdom
facility: Research Site
city: Sheffield
country: United Kingdom
facility: Research Site
city: Taunton
country: United Kingdom
facility: Research Site
city: Wolverhampton
country: United Kingdom
facility: Research Site
city: Valencia
country: Venezuela
facility: Research Site
state: Carabobo
city: Caracas
country: Venezuela
facility: Research Site
state: Miranda
Study officials:
affiliation: AstraZeneca GMA
name: Lin Zhang, M.D., PhD
role: STUDY_CHAIR
affiliation: Concord Repatriation General Hospital
name: David Brieger, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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