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2019 | HFSA

BRILINTA’s Phase III THEMIS Trial met Primary Endopoint in Patients with Established Coronary Artery Disease and Type-2 Diabetes

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AstraZeneca is pleased to share that the Phase III THEMIS trial met its primary endpoint which demonstrated that BRILINTA® (ticagrelor) tablets, taken in conjunction with aspirin, showed a statistically-significant reduction in major adverse cardiovascular events (MACE, a composite of cardiovascular death, heart attack and stroke) 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 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.

BRILINTA is not approved for use in patients with CAD and T2D who have not yet had a heart attack or stroke.

BRILINTA is indicated to reduce the rate of cardiovascular death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of myocardial infarction. For at least the first 12 months following ACS, it is superior to clopidogrel.

BRILINTA also reduces the rate of stent thrombosis in patients who have been stented for treatment of ACS.  For the press release and more information, go here.