At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 19,271 enrolled
Drug / intervention
Ticagrelor 60 mg +1 moredrug
Likely dose
Ticagrelor 60 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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).
In Brief
A Phase 3 clinical trial evaluating Ticagrelor 60 mg and Ticagrelor placebo for Diabetes Mellitus, Type 2. Completed, enrolled 19,271 participants across 1,237 sites in 43 countries.
Detailed Summary
The purpose of this study is to compare the effect of ticagrelor versus placebo in patients with Type 2 Diabetes Mellitus.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesArgentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Puerto Rico, Romania, Russia, Saudi Arabia, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States, Vietnam
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 2013
Enrollment StartFeb 2014
Primary CompletionJan 2019
TodayJul 2026
First PostedNov 25, 2013
Enrollment StartFeb 10, 2014
Primary CompletionJan 25, 2019
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 12.6 years ago
Interventions
Ticagrelor 60 mgdrug
Ticagrelor 60 mg bd taken orally as tablets
Ticagrelor placebodrug
Ticagrelor placebo bd taken orally as tablets