Overview

This trial is active, not recruiting.

Condition diabetes mellitus, type 2
Treatments ticagrelor 60 mg, ticagrelor placebo
Phase phase 3
Sponsor AstraZeneca
Start date February 2014
End date January 2018
Trial size 19000 participants
Trial identifier NCT01991795, D513BC00001

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
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.
ticagrelor 60 mg Brilinta/Brilique
Ticagrelor 60 mg bd taken orally as tablets
(Placebo Comparator)
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.
ticagrelor placebo
Ticagrelor placebo bd taken orally as tablets

Primary Outcomes

Measure
Time from randomisation to first occurrence of any event from the composite of CV death, MI or stroke
time frame: Up to 48 months

Secondary Outcomes

Measure
Prevention of CV death. The efficacy variable is time from randomisation to death of CV cause
time frame: Up to 48 months
Prevention of MI. The efficacy variable is time from randomisation to first occurrence of MI
time frame: Up to 48 months
Prevention of ischaemic stroke. The efficacy variable is time from randomisation to first occurrence of ischaemic stroke
time frame: Up to 48 months
Prevention of all-cause death. The efficacy variable is time from randomisation to death of any cause
time frame: Up to 48 months

Eligibility Criteria

Male or female participants from 50 years up to 130 years old.

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

Additional Information

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)
Principal investigator Philippe Gabriel Steg, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.