Study identifier:D513BC00001
ClinicalTrials.gov identifier:NCT01991795
EudraCT identifier:N/A
CTIS identifier:N/A
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).
Diabetes Mellitus, Type 2
Phase 3
No
Ticagrelor 60 mg, Ticagrelor placebo
All
19271
Interventional
50 Years - 130 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Prevention
Verified 01 Aug 2020 by AstraZeneca
AstraZeneca
-
The purpose of this study is to compare the effect of ticagrelor versus placebo in patients with Type 2 Diabetes Mellitus.
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
Location
Location
Budapest, Hungary, 1134
Location
Balatonfüred, Hungary, 8230
Location
Kecskemét, Hungary, 6000
Location
Kalocsa, Hungary, 6300
Location
Debrecen, Hungary, 4032
Location
Sopron, Hungary, 9400
Location
Budapest, Hungary, 1096
Location
Mosonmagyaróvár, Hungary, 9200
Arms | Assigned Interventions |
---|---|
Experimental: Ticagrelor 60 mg Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1. | Drug: Ticagrelor 60 mg Ticagrelor 60 mg bd taken orally as tablets Other Name: Brilinta/Brilique |
Placebo Comparator: Ticagrelor placebo Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1. | Drug: Ticagrelor placebo Ticagrelor placebo bd taken orally as tablets |
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