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