Clinical trial NCT01991795: A Study Comparing Cardiovascular Effects of Ticagrelor Versus Placebo in Patients With Type 2 Diabetes Mellitus
Official title: A Multinational, Randomised, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Ticagrelor Twice Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Stroke in Patients With Type 2 Diabetes Mellitus (THEMIS - Effect of Ticagrelor on Health Outcomes in Diabetes Mellitus Patients Intervention Study).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes
Coronary artery disease
Outcome
Prevention
Antiplatelet
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-11-25
Enrollment: 19271
Sex: ALL
Minimum age (years): 50
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare the effect of ticagrelor versus placebo in patients with Type 2 Diabetes Mellitus.

Detailed description: A multinational, randomised, double-blind, placebo-controlled phase IIIb trial to evaluate the effect of ticagrelor twice daily on the incidence of cardiovascular death, myocardial infarction or stroke in patients with type 2 diabetes mellitus

Eligibility criteria: Inclusion Criteria:

Men or women ≥50 years of age with type 2 diabetes mellitus on treatment with a glucose lowering medication since at least 6 months, and either documented coronary artery occlusive disease or previous revascularization of a coronary artery.

Key Exclusion Criteria:

History of myocardial infarction or any stroke; planned treatment with agents inhibiting blood clotting; planned use of ASA/Aspirin at doses above 150 mg daily; planned coronary, cerebrovascular, or peripheral arterial revascularization; patients with known bleeding disorders and patients who need chronic oral anticoagulant therapy or chronic low-molecular-weight heparin; history of intracranial bleeding at any time, or a history of bleeding from the gastrointestinal tract within the last 6 months or a major surgery within the last 30 days; patients with known severe liver disease or with kidney failure requiring dialysis

Primary outcomes:
measure: Composite of Cardiovascular (CV) Death, MI or Stroke
timeFrame: From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.
Secondary outcomes:
measure: CV Death
timeFrame: From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.
measure: MI
timeFrame: From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.
measure: Ischaemic Stroke
timeFrame: From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.
measure: All-cause Death
timeFrame: From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.
Other outcomes:
measure: TIMI Major Bleeding Event (Primary Safety Objective)
timeFrame: From randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.
measure: TIMI Major or Minor Bleeding Event
timeFrame: From randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.
measure: PLATO Major Bleeding Event
timeFrame: From randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.
measure: Permanent Discontinuation of Study Medication Due to Any Bleeding Event
timeFrame: From randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.
Locations:
city: Alexander City
country: United States
facility: Research Site
state: Alabama
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Fairhope
country: United States
facility: Research Site
state: Alabama
city: Huntsville
country: United States
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city: Huntsville
country: United States
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state: Alabama
city: Mobile
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city: Montgomery
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city: Sheffield
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city: Tuscumbia
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city: Cottonwood
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city: Little Rock
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city: Beverly Hills
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city: Bangor
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city: Bowie
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city: Glen Burnie
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city: Prince Frederick
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city: North Attleboro
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city: North Kansas City
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city: East Brunswick
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city: Toms River
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city: Voorhees
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city: Albuquerque
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city: Binghamton
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city: Hawthorne
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city: Orchard Park
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facility: Research Site
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facility: Research Site
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facility: Research Site
city: Cordoba
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facility: Research Site
city: Cordoba
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facility: Research Site
city: Mar del Plata
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facility: Research Site
city: Mar del Plata
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facility: Research Site
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facility: Research Site
city: Rosario
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facility: Research Site
city: Rosario
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facility: Research Site
city: Rosario
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facility: Research Site
city: San Luis
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facility: Research Site
city: San Miguel de Tucuman
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facility: Research Site
city: San Miguel de Tucuman
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facility: Research Site
city: San Nicolás
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facility: Research Site
city: Santa Fe
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facility: Research Site
city: Venado Tuerto
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facility: Research Site
city: Villa Maria
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
city: Heidelberg West
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
state: Ontario
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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country: Italy
facility: Research Site
city: San Giovanni Rotondo
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facility: Research Site
city: Västerås
country: Sweden
facility: Research Site
city: Örebro
country: Sweden
facility: Research Site
city: Changhua City
country: Taiwan
facility: Research Site
city: Hsinchu
country: Taiwan
facility: Research Site
city: Hualien City
country: Taiwan
facility: Research Site
city: Kaohsiung City
country: Taiwan
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Kweishan Shiang
country: Taiwan
facility: Research Site
city: New Taipei City
country: Taiwan
facility: Research Site
city: New Taipei City
country: Taiwan
facility: Research Site
city: Pingtung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Tainan
country: Taiwan
facility: Research Site
city: Tainan
country: Taiwan
facility: Research Site
city: Tainan
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Bangkoknoi
country: Thailand
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Chiang Mai
country: Thailand
facility: Research Site
city: Hat Yai
country: Thailand
facility: Research Site
city: Muang
country: Thailand
facility: Research Site
city: Naimuang
country: Thailand
facility: Research Site
city: Adana
country: Turkey
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Antalya
country: Turkey
facility: Research Site
city: Antalya
country: Turkey
facility: Research Site
city: Aydin
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: İstanbul
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Mersin
country: Turkey
facility: Research Site
city: Belo Horizonte
country: Ukraine
facility: Research Site
city: Cherkasy
country: Ukraine
facility: Research Site
city: Dnipro
country: Ukraine
facility: Research Site
city: Dnipro
country: Ukraine
facility: Research Site
city: Dnipro
country: Ukraine
facility: Research Site
city: Ivano-Frankivsk
country: Ukraine
facility: Research Site
city: Ivano-Frankivsk
country: Ukraine
facility: Research Site
city: Kharkiv Region
country: Ukraine
facility: Research Site
city: Kharkiv Region
country: Ukraine
facility: Research Site
city: Kharkiv Region
country: Ukraine
facility: Research Site
city: Kharkiv Region
country: Ukraine
facility: Research Site
city: Kharkiv Region
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Lutsk
country: Ukraine
facility: Research Site
city: Lviv
country: Ukraine
facility: Research Site
city: Lviv
country: Ukraine
facility: Research Site
city: Mykolaiv
country: Ukraine
facility: Research Site
city: Odesa
country: Ukraine
facility: Research Site
city: Odesa
country: Ukraine
facility: Research Site
city: Odesa
country: Ukraine
facility: Research Site
city: Poltava
country: Ukraine
facility: Research Site
city: Rivne
country: Ukraine
facility: Research Site
city: Ternopil
country: Ukraine
facility: Research Site
city: Uzhhorod
country: Ukraine
facility: Research Site
city: Vinnytsia
country: Ukraine
facility: Research Site
city: Vinnytsia
country: Ukraine
facility: Research Site
city: Vinnytsia
country: Ukraine
facility: Research Site
city: Zaporizhzhia
country: Ukraine
facility: Research Site
city: Zaporizhzhia
country: Ukraine
facility: Research Site
city: Airdrie
country: United Kingdom
facility: Research Site
city: Antrim
country: United Kingdom
facility: Research Site
city: Belfast
country: United Kingdom
facility: Research Site
city: Chesterfield
country: United Kingdom
facility: Research Site
city: Coventry
country: United Kingdom
facility: Research Site
city: Doncaster
country: United Kingdom
facility: Research Site
city: Dundee
country: United Kingdom
facility: Research Site
city: Durham
country: United Kingdom
facility: Research Site
city: Exeter
country: United Kingdom
facility: Research Site
city: Faringdon
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Harrogate
country: United Kingdom
facility: Research Site
city: High Wycombe
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Middlesborough
country: United Kingdom
facility: Research Site
city: Newcastle-Upon-Tyne
country: United Kingdom
facility: Research Site
city: Northampton
country: United Kingdom
facility: Research Site
city: Nottingham
country: United Kingdom
facility: Research Site
city: Paisley
country: United Kingdom
facility: Research Site
city: Peterborough
country: United Kingdom
facility: Research Site
city: Plymouth
country: United Kingdom
facility: Research Site
city: Rotherham
country: United Kingdom
facility: Research Site
city: Rothwell
country: United Kingdom
facility: Research Site
city: Sheffield
country: United Kingdom
facility: Research Site
city: Swansea
country: United Kingdom
facility: Research Site
city: Torquay
country: United Kingdom
facility: Research Site
city: York
country: United Kingdom
facility: Research Site
city: Hanoi
country: Vietnam
facility: Research Site
city: Hcmc
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
city: Hochiminh
country: Vietnam
facility: Research Site
Study officials:
affiliation: Hôpital Bichat-Claude Bernard 46 Rue Henri Huchard, Paris
name: Philippe Gabriel Steg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital75 Francis Street, Boston
name: Deepak L. Bhatt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Steg PG, Bhatt DL, Simon T, Fox K, Mehta SR, Harrington RA, Held C, Andersson M, Himmelmann A, Ridderstrale W, Leonsson-Zachrisson M, Liu Y, Opolski G, Zateyshchikov D, Ge J, Nicolau JC, Corbalan R, Cornel JH, Widimsky P, Leiter LA; THEMIS Steering Committee and Investigators. Ticagrelor in Patients with Stable Coronary Disease and Diabetes. N Engl J Med. 2019 Oct 3;381(14):1309-1320. doi: 10.1056/NEJMoa1908077. Epub 2019 Sep 1.
citation: Bhatt DL, Steg PG, Mehta SR, Leiter LA, Simon T, Fox K, Held C, Andersson M, Himmelmann A, Ridderstrale W, Chen J, Song Y, Diaz R, Goto S, James SK, Ray KK, Parkhomenko AN, Kosiborod MN, McGuire DK, Harrington RA; THEMIS Steering Committee and Investigators. Ticagrelor in patients with diabetes and stable coronary artery disease with a history of previous percutaneous coronary intervention (THEMIS-PCI): a phase 3, placebo-controlled, randomised trial. Lancet. 2019 Sep 28;394(10204):1169-1180. doi: 10.1016/S0140-6736(19)31887-2. Epub 2019 Sep 1.
citation: Bhatt DL, Fox K, Harrington RA, Leiter LA, Mehta SR, Simon T, Andersson M, Himmelmann A, Ridderstrale W, Held C, Steg PG; THEMIS Steering Committee. Rationale, design and baseline characteristics of the effect of ticagrelor on health outcomes in diabetes mellitus patients Intervention study. Clin Cardiol. 2019 May;42(5):498-505. doi: 10.1002/clc.23164. Epub 2019 Apr 9.
citation: Abtan J, Bhatt DL, Elbez Y, Ducrocq G, Goto S, Smith SC Jr, Ohman EM, Eagle KA, Fox K, Harrington RA, Leiter LA, Mehta SR, Simon T, Petrov I, Sinnaeve PR, Pais P, Lev E, Bueno H, Wilson P, Steg PG; REACH Registry Investigators. External applicability of the Effect of ticagrelor on Health Outcomes in diabEtes Mellitus patients Intervention Study (THEMIS) trial: An analysis of patients with diabetes and coronary artery disease in the REduction of Atherothrombosis for Continued Health (REACH) registry. Int J Cardiol. 2023 Jan 1;370:51-57. doi: 10.1016/j.ijcard.2022.10.132. Epub 2022 Oct 19.
citation: Wittbrodt E, Bhalla N, Sundell KA, Hunt P, Wong ND, Kuster M, Mellstrom C. Assessment of The High risk and unmEt Need in patients with CAD and type 2 diabetes (ATHENA): US healthcare resource use, cost, and burden of illness in a commercially insured population. J Diabetes Complications. 2021 Apr;35(4):107859. doi: 10.1016/j.jdiacomp.2021.107859. Epub 2021 Jan 20.
citation: Held P, Himmelmann A, Ditmarsch M. Ticagrelor for the treatment of atherosclerotic disease: insights from the PARTHENON clinical development program. Future Cardiol. 2016 Jul;12(4):405-18. doi: 10.2217/fca-2016-0028. Epub 2016 May 10.