A Study Comparing Cardiovascular Effects of Ticagrelor versus Placebo in Patients with Type 2 Diabetes Mellitus - THEMIS
Study identifier:D513BC00001
ClinicalTrials.gov identifier:NCT01991795
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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).
Medical condition
Diabetes Mellitus, Type 2
Phase
Phase 3
Healthy volunteers
No
Study drug
Ticagrelor 60 mg, Ticagrelor placebo
Sex
All
Actual Enrollment
19271
Study type
Interventional
Age
50 Years - 130 Years
Date
Study Start Date: 10 Feb 2014
Primary Completion Date: 25 Jan 2019
Study Completion Date: 25 Jan 2019
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Prevention
Verification:
Verified 01 Aug 2020 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| 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 |
Contacts
Investigators
Principal Investigator
Philippe Gabriel Steg
Hôpital Bichat-Claude Bernard 46 Rue Henri Huchard, Paris
