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14.03.2015 16:45:07

AstraZeneca Announces Results From PEGASUS-TIMI 54 Study

(RTTNews) - AstraZeneca (AZN, AZN.L) announced full results from the PEGASUS-TIMI 54 study, a large-scale outcomes trial that investigated BRILINTA (ticagrelor) tablets plus low dose aspirin, compared to placebo plus low dose aspirin, for chronic secondary prevention of atherothrombotic events in patients who had experienced a heart attack one to three years prior to study enrollment.

The company noted that Both 90mg and 60mg study doses of ticagrelor with aspirin significantly reduced the primary composite endpoint of cardiovascular (CV) death, myocardial infarction (MI) or stroke compared to placebo.

As expected with an oral antiplatelet, TIMI Major Bleeding, the study's primary safety endpoint, was higher with both doses of ticagrelor plus aspirin compared to placebo plus aspirin. Importantly, the rates of intracranial hemorrhage (bleeding within the skull) and fatal bleeding were low and similar between study groups and the placebo arm, the company said.

BRILINTA is not approved for secondary prevention of atherothrombotic events in patients with a history of heart attack beyond one year or for the prevention of cardiovascular events in patients with peripheral arterial disease, stroke, diabetes or atherosclerosis.

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