NCT01866904

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.

Trial Health

68
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
9,284

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2013

Typical duration for all trials

Geographic Reach
25 countries

309 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 3, 2013

Completed
16 days until next milestone

Study Start

First participant enrolled

June 19, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
Last Updated

September 4, 2018

Status Verified

August 1, 2018

Enrollment Period

3.8 years

First QC Date

May 29, 2013

Last Update Submit

August 30, 2018

Conditions

Keywords

Coronary artery disease, Myocardial infarction

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Ischemic events (MI, unstable angina with urgent revascularization, ischemic stroke, CV death or death with unknown reason)

    in a 3-year follow-up period

  • Bleeding events which require medical attention

    in a 3 year follow-up period

Study Arms (1)

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

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • \- 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (309)

Research Site

Huntsville, Alabama, United States

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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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Clearwater, Florida, United States

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Miami, Florida, United States

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Tallahassee, Florida, United States

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Tucker, Georgia, United States

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Arlington Heights, Illinois, United States

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Englewood, Illinois, United States

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Lebanon, Indiana, United States

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Auburn, Maine, United States

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Bangor, Maine, United States

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Columbia, Maryland, United States

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Jackson, Michigan, United States

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Minneapolis, Minnesota, United States

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Manhasset, New York, United States

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Chapel Hill, North Carolina, United States

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Durham, North Carolina, United States

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Sandusky, Ohio, United States

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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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Providence, Rhode Island, United States

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Jackson, Tennessee, United States

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Houston, Texas, United States

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Plano, Texas, United States

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Burlington, Vermont, United States

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Falls Church, Virginia, United States

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Manassas, Virginia, United States

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Seattle, Washington, United States

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Spokane, Washington, United States

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Buenos Aires, Argentina

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Corrientes, Argentina

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Córdoba, Argentina

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Mendoza, Argentina

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Salta, Argentina

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Santa Fe, Argentina

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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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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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Epping, Victoria, Australia

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Parkville, Victoria, Australia

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Richmond, Victoria, 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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Brussels, Belgium

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Genk, Belgium

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Ghent, Belgium

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Kortrijk, Belgium

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Ostend, Belgium

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Overpelt, Belgium

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Veurne, Belgium

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Campo Grande, Mato Grosso do Sul, Brazil

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Blumenal, Santa Cantarina, Brazil

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Marília, São Paulo, Brazil

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São José do Rio Preto, São Paulo, Brazil

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Saint John, New Brunswick, Canada

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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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Greenfield Park, Quebec, Canada

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Montreal, Quebec, Canada

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Saint-Jérôme, Quebec, Canada

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Thetford-Mines, Quebec, Canada

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Québec, Canada

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Beijing, Beijing Municipality, China

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Chongqing, Chongqing Municipality, China

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Lanzhou, Gansu, China

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Guangzhou, Guangdong, China

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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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Changchun, Jilin, China

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Jinzhou, Liaoning, China

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Jinan, Shandong, China

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Shanghai, Shanghai Municipality, China

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Xian, Shanxi, China

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Taiyuan, Shanyuan, China

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Tianjin, Tianjin Municipality, China

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Kunming, Yunnan, China

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Medellín, Antioquia, Colombia

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Barranquilla, Atlántico, Colombia

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Cartagena, Caldas Department, Colombia

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Manizales, Caldas Department, Colombia

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Bucaramanga, Santander Dept, Colombia

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Cali, Valle del Cauca Department, Colombia

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Aalborg, Denmark

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Arhus N, Denmark

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Copenhagen, Denmark

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Haderslev, Denmark

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Hellerup, Denmark

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København NV, Denmark

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København S, Denmark

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Randers, Denmark

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Jyväskylä, 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, 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, France

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Roubaix, France

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Salouël, 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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Cologne, 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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Leipzig, Germany

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Leverkusen, Germany

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Ludwigshafen, Germany

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Lübeck, Germany

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Mainz, Germany

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Merseburg, Germany

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Mönchengladbach, Germany

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München, 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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Hyderabad, Andhra Pradesh, India

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Surat, Gujarat, India

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Bangalore, Karnataka, India

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Thrisur, Kerala, India

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Trivandrum, Kerala, India

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Indore, Madhya Pradesh, India

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Mumbai, Maharashtra, India

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Pune, Maharashtra, India

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New Delhi, National Capital Territory of Delhi, India

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Mohali, Punjab, India

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Jaipur, Rajasthan, India

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Chennai, Tamil Nadu, India

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Madurai, Tamil Nadu, India

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Noida, Uttar Pradesh, India

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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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Milan, 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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Toyoake-shi, Aichi-ken, Japan

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Chiba, Chiba, Japan

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Kisarazu-shi, Chiba, Japan

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Matsuyama, Ehime, Japan

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Fukui-shi, Fukui, Japan

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Fukuoka, Fukuoka, Japan

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Kurume-shi, Fukuoka, Japan

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Maebashi, Gunma, Japan

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Hiroshima, Hiroshima, Japan

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Sapporo, Hokkaido, Japan

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Tomakomai-shi, Hokkaido, Japan

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Amagasaki-shi, Hyōgo, Japan

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Kanazawa, Ishikawa-ken, Japan

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Morioka, Iwate, Japan

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Isehara-shi, Kanagawa, Japan

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Sagamihara-shi, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Kochi, Kochi, Japan

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Kumamoto, Kumamoto, Japan

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Sendai, Miyagi, Japan

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Tenri-shi, Nara, Japan

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Hirakata-shi, Osaka, Japan

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Osaka, Osaka, Japan

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Suita-shi, Osaka, Japan

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Kusatsu-shi, Shiga, Japan

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Izunokuni-shi, Shizuoka, Japan

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Shizuoka, Shizuoka, Japan

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Komatsujima-shi, Tokushima, Japan

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Bunkyo-ku, Tokyo, Japan

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Chuo-Ku, Tokyo, Japan

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Wakayama, Wakayama, Japan

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Torreón, Coahuila, Mexico

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Tijuana, Estado de Baja California, Mexico

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Guadalajara, Jalisco, Mexico

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Mexico City, Mexico City, Mexico

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Querétaro City, Querétaro, Mexico

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Toluca, State of Mexico, Mexico

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Chihuahua City, Mexico

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Oaxaca City, Mexico

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Puebla City, Mexico

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San Luis Potosí City, 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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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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The Hague, 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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Lisbon, Portugal

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Porto, Portugal

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Senhora da Hora, Portugal

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Setúbal, Portugal

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Viana do Castelo, Portugal

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Arad, Romania

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Brăila, Romania

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Bucharest, 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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Focşani, Romania

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Piteşti, Romania

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Sibiu, Romania

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Slatina, Romania

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Timișoara, Romania

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Chungcheongbuk-do, Cheongju-si, South Korea

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Wŏnju, Gangwon-do, South Korea

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Jinju, Gyeongsangnam-do, South Korea

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Jeonju, Jeollabuk-do, South Korea

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Gwangju, Jeollanam-do, South Korea

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Daejeon, Jung-gu, South Korea

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Daegu, Nam-gu, South Korea

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Busan, Seo-gu, South Korea

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Seoul, Sudogwon, South Korea

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Seville, Andalusia, Spain

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Palma de Mallorca, Balearic Islands, Spain

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Toledo, Castille-La Mancha, Spain

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Barcelona, Catalonia, Spain

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Vic, Catalonia, Spain

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Cáceres, Extremadura, Spain

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Santiago de Compostela, Galicia, Spain

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Baza, Granada, Spain

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Alicante, Spain

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Almería, 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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Ankara, Turkey (Türkiye)

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Aydin, Turkey (Türkiye)

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Diyarbak?r, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Merkez, Turkey (Türkiye)

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Mersin, Turkey (Türkiye)

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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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Valencia, Carabobo, Venezuela

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Caracas, Miranda, Venezuela

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Related Publications (9)

  • 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.

  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Myocardial InfarctionCoronary Artery Disease, Autosomal Dominant, 1

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Lin Zhang, M.D., PhD

    AstraZeneca GMA

    STUDY CHAIR
  • David Brieger, MBBS, PhD

    Concord Repatriation General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2013

First Posted

June 3, 2013

Study Start

June 19, 2013

Primary Completion

March 31, 2017

Study Completion

March 31, 2017

Last Updated

September 4, 2018

Record last verified: 2018-08

Locations