Brilinta was being tested against clopidogrel in 13,885 patients in 28 countries. The study, dubbed Euclid, is the largest trial of its kind in such patients and forms part of a larger program testing Brilinta in patients with PAD and diabetes.
The trial assessed the treatment of Brilinta 90mg tablets twice daily versus clopidogrel 75mg once daily for the prevention of atherothrombotic events (a composite of cardiovascular death, heart attack or ischaemic stroke).
The time to first occurrence of any such event was the trial’s primary endpoint, which was not met.
AstraZeneca said depending on preliminary analyses, safety data is consistent with the known safety profile of Brilinta.
AstraZeneca executive vice president of global medicines development and chief medical officer Sean Bohen said: “The proven benefits of Brilinta in acute coronary syndrome and post-myocardial infarction patients are established and remain unchanged.
“We are disappointed that the Euclid trial results showed Brilinta did not demonstrate a benefit over clopidogrel in this specific symptomatic PAD population.”
Brilinta, which inhibits platelet activation, has been demonstrated to reduce the rate of atherothrombotic cardiovascular (CV) events, like heart attack or CV death, in patients with acute coronary syndrome (ACS).
It is used to lower the chance of having another heart attack or dying from a heart attack or stroke.
However, Brilinta can reportedly cause bleeding that can be severe and sometimes result in death.