In the phase 3 EUCLID trial, ticagrelor (Brilinta) did not demonstrate a benefit over clopidogrel in patients with symptomatic peripheral artery disease (PAD) and therefore did not meet the study’s primary endpoint, AstraZeneca has announced.
The double-blind, parallel-group EUCLID (Examining Use of TiCagreLor In PAD) trial included 13,885 patients in 28 countries and is the largest cardiovascular (CV) outcomes trial conducted exclusively in symptomatic adults (50 years of age or older) with PAD. The study compared ticagrelor (90 mg twice daily) with clopidogrel (75 mg once daily) for the prevention of atherothrombotic events (a composite of CV death, heart attack, or ischemic stroke). The trial’s primary endpoint was the time to first occurrence of any of these events.
While AstraZeneca has announced top-line results from EUCLID, full results from the trial are expected to be presented at the American Heart Association Scientific Sessions in New Orleans, Louisiana, in November.
Ticagrelor is a direct-acting platelet P2Y12 receptor antagonist in a chemical class known as cyclo-pentyl-triazolo-pyrimidines.The drug works by inhibiting platelet activation and has been shown to reduce the rate of atherothrombotic CV events, such as heart attack or CV death, in patients with acute coronary syndrome (ACS).
Ticagrelor 90 mg is indicated to reduce the rate of atherothrombotic CV events in patients with ACS (i.e., unstable angina, non–ST-elevation myocardial infarction [NSTEMI], or ST-elevation myocardial infarction [STEMI]). Ticagrelor 60 mg is indicated for the treatment of patients who have experienced a heart attack at least one year prior and are at high risk of developing an additional atherothrombotic event. Treatment with ticagrelor 60 mg may be started as continuation therapy after an initial one year of treatment with ticagrelor 90 mg and aspirin or another dual antiplatelet therapy.
Ticagrelor has been shown to reduce the rate of a combined endpoint of CV death, MI, or stroke compared with clopidogrel. The difference between the two treatments was driven by CV death and MI, with no difference in stroke. Ticagrelor also reduces the rate of stent thrombosis in patients undergoing percutaneous coronary intervention.
PAD is the third most-common cause of cardiovascular complications (largely MI and stroke) in the world. It is a chronic and progressive clinical manifestation of systemic atherosclerotic vascular disease and is a predictor of future vascular events. However, only a limited number of patients with PAD receive the treatment advocated in international guidelines. There is no cure for the disease, and patients are at high risk of serious cardiovascular morbidity and mortality.
Source: AstraZeneca; October 4, 2016.