Brilinta + aspirin in phase III THEMIS trial showed a statistically-significant reduction in major adverse CV events compared to aspirin. AstraZeneca
The Phase III THEMIS trial met its primary endpoint and demonstrated that Brilinta (ticagrelor), taken in conjunction with aspirin, showed a statistically-significant reduction in a composite of major adverse cardiovascular events (MACE) compared to aspirin alone. THEMIS was conducted in over 19,000 patients with coronary artery disease (CAD) and type-2 diabetes (T2D) with no prior heart attack (myocardial infarction, MI) or stroke. Preliminary safety results were consistent with the known profile of Brilinta. A full evaluation of the THEMIS data will be presented at a forthcoming medical meeting.
About THEMIS : THEMIS (Effect of Ticagrelor on Health Outcomes in DiabEtes Mellitus Patients Intervention Study) is an AstraZeneca-sponsored, multi-national, randomised, double?blinded trial in patients with CAD and T2D with no prior myocardial infarction or stroke. THEMIS was designed to test the hypothesis that Brilinta plus aspirin would reduce major adverse cardiovascular events (MACE), a composite of CV death, myocardial infarction or stroke, in patients with CAD and T2D with no prior myocardial infarction or stroke, vs. aspirin alone. CAD was defined as a prior percutaneous coronary intervention (PCI), bypass surgery or at least a 50% narrowing of a coronary artery.