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Ticagrelor in Type 2 Diabetes Mellitus
NCT01991795Phase 3
Key facts
- Status
- Completed
- Start
- Feb 2014
- Primary completion
- Jan 2019
- Countries
- 43
- Sponsor
- AstraZeneca
- Modality
- Small Molecules
- Drugs
- ticagrelor
- Conditions
- type 2 diabetes mellitus (T2DM)
01
Overview
Phase 3, randomised, double-blind trial in type 2 diabetes mellitus (T2DM) comparing Ticagrelor + Aspirin with Placebo + Aspirin (2 arms). Primary endpoint: Composite of Cardiovascular Death, Myocardial Infarction or Stroke at 40 months. Started Feb 2014; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Ticagrelor + Aspirin
Ticagrelor 60 mg twice daily + Aspirin
Placebo + Aspirin
Placebo twice daily + Aspirin
03
Who it enrols
Patients >=50 years with Type 2 Diabetes Mellitus and stable Coronary Artery Disease (history of PCI, CABG, or angiographic stenosis >=50%). Excludes prior MI or Stroke.
04
Endpoints
Primary
Composite of Cardiovascular Death, Myocardial Infarction or Stroke
Secondary
Cardiovascular Death
Myocardial Infarction
Ischaemic Stroke
All-cause Death
05
Results
Primary endpoints met
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