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).
Overview
- Phase
- Phase 3
- Intervention
- Ticagrelor 60 mg
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- AstraZeneca
- Enrollment
- 19271
- Locations
- 1
- Primary Endpoint
- Composite of Cardiovascular (CV) Death, MI or Stroke
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of this study is to compare the effect of ticagrelor versus placebo in patients with Type 2 Diabetes Mellitus.
Detailed 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
Investigators
Eligibility Criteria
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.
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
Arms & Interventions
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.
Intervention: Ticagrelor 60 mg
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.
Intervention: Ticagrelor placebo
Outcomes
Primary Outcomes
Composite of Cardiovascular (CV) Death, MI or Stroke
Time Frame: From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.
Participants with Cardiovascular (CV) death, myocardial infarction (MI) or stroke. If no event, censoring occurs at the earliest of PACD, last endpoint assessment date and non-CV death date.
Secondary Outcomes
- All-cause Death(From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.)
- CV Death(From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.)
- Ischaemic Stroke(From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.)
- MI(From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.)