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AstraZeneca to assess Brilinta in patients with diabetes, ischemic stroke
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AstraZeneca has announced two phase 3b studies assessing the efficacy of its oral antiplatelet therapy ticagrelor for the treatment of ACS in high-risk populations.
The randomized, parallel-group SOCRATES trial will assess the efficacy of direct-acting P2Y12 receptor antagonist ticagrelor (Brilinta, AstraZeneca) compared with aspirin in the reduction of all-cause mortality, nonfatal MI and nonfatal stroke in 9,600 patients with acute ischemic stroke.
“The short-term stroke risk after a transient ischemic attack and minor ischemic stroke is extremely high, with more than 10% of patients having a major stroke within 90 days; and this is with aspirin,” Clay Johnson, MD, PhD, director of the Clinical and Translational Science Institute at University of California, San Francisco, said in a press release. “We need better medicines in this setting, and SOCRATES will tell us whether ticagrelor might be such a medicine.”
The THEMIS trial, also a randomized parallel-group study, will evaluate the long-term efficacy of twice-daily 90 mg ticagrelor compared with placebo for the prevention of CV-related mortality, MI or stroke in a cohort of 17,000 patients with type 2 diabetes and coronary atherosclerosis.
“THEMIS will allow us to test a new strategy in the care of patients with diabetes who are at high risk of MI, stroke and CV death,” study co-chair Philippe Gabriel Steg, MD, professor of medicine at Université Paris-Diderot in Paris, said in the release.
The two studies are part of the company’s PARTHENON clinical trial program, assessing ticagrelor in more than 80,000 patients across multiple studies worldwide.