EUCLID trial results for BRILINTA/BRILIQUE presented at the American Heart Association Scientific Sessions

13 November 2016

AstraZeneca today announced detailed results of the EUCLID trial, assessing the efficacy and safety of BRILINTA (ticagrelor) 90mg tablets twice daily, when compared to clopidogrel 75mg once daily for the prevention of atherothrombotic events (a composite of cardiovascular (CV) death, heart attack or ischaemic stroke) in patients with established symptomatic peripheral artery disease (PAD). BRILINTA did not meet the primary efficacy endpoint of superiority compared to clopidogrel.  The treatment effect for ticagrelor was numerically similar to clopidogrel in this patient population. The data were presented during the first late-breaker session at the American Heart Association (AHA) Scientific Sessions in New Orleans, Louisiana.

Elisabeth Björk, Vice President CVMD, Global Medicines Development at AstraZeneca, said: "Although the overall trial did not meet its primary efficacy endpoint, the safety profile for BRILINTA was consistent with the known safety profile of the medicine and we’ll continue to evaluate the full data set. The EUCLID trial is an example of AstraZeneca’s commitment to following science into new areas to address unmet patient need. The proven clinical profile and indications for BRILINTA based on the PLATO and PEGASUS-TIMI 54 trials in patients with acute coronary syndromes (ACS) or a history of myocardial infarction (MI) remain unchanged."

At a median follow-up of approximately 30-months, the primary efficacy composite endpoint of CV death, MI, or ischemic stroke occurred in 751 (10.8%) patients treated with ticagrelor, versus 740 (10.6%) treated with clopidogrel (HR 1.02, 95% CI 0.92–1.13; p=0.65).

TIMI major bleeding - the primary safety outcome - occurred in 113 patients (1.6%) and 109 patients (1.6%) treated with ticagrelor and clopidogrel respectively (HR 1.10, 95% CI 0.84–1.43; p=0.49). Fatal bleeding (0.1% vs 0.3%), intracranial bleeding (0.5% vs 0.5%), and TIMI minor bleeding (1.2% vs 1.0%) were similar overall between the treatment groups.

NOTES TO EDITORS

About Peripheral Artery Disease (PAD)
PAD is the third most common cause of cardiovascular complications (largely myocardial infarction and stroke) in the world. PAD is a chronic and progressive clinical manifestation of a systemic atherosclerotic vascular disease and a predictor of future vascular events. However, only a limited number of PAD patients receive the recommended treatment advocated in international guidelines. There is no cure and patients endure a high risk of serious cardiovascular morbidity and mortality. 

About EUCLID
EUCLID (Examining Use of tiCagreLor In paD) is a global, event-driven, double-blind, parallel group trial involving approximately 13,800 patients in 28 countries, and was run for AstraZeneca by The Duke Clinical Research Institute (DCRI), part of the Duke University School of Medicine, Durham, North Carolina. The EUCLID trial evaluated the efficacy and safety of long-term treatment with BRILINTA 90mg twice daily compared to clopidogrel 75mg once daily for the prevention of atherothrombotic events (a composite of ischaemic stroke, myocardial infarction and CV death) in patients ≥50 years of age with symptomatic PAD, defined by ankle-brachial index (ABI) ≤0.80 (at enrolment) and lower extremity symptoms, or by prior lower extremity revascularisation more than 30 days prior.

About the PARTHENON programme
PARTHENON is the largest-ever AstraZeneca CV outcomes programme, involving nearly 85,000 patients at high risk of CV events (MI, stroke and/or CV death) due to their underlying disease. Through the PARTHENON programme, AstraZeneca aims to address unmet patient needs by enhancing scientific understanding of the potential role of BRILINTA in the treatment of atherothrombotic conditions. It includes five key trials covering broad patient populations across varying timescales. The trials encompass a wide range of CV disorders, including coronary artery disease (PEGASUS-TIMI 54), acute coronary syndrome (PLATO), stroke (SOCRATES) and patients with type 2 diabetes at high risk of CV events (THEMIS).

About BRILINTA
BRILINTA is a direct-acting P2Y₁₂ receptor antagonist in a chemical class called cyclo-pentyl-triazolo-pyrimidines (CPTPs). BRILINTA 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).

BRILINTA 90mg is indicated to reduce the rate of atherothrombotic CV events in patients with ACS [unstable angina (UA), non–ST-elevation myocardial infarction (NSTEMI), or ST-elevation myocardial infarction (STEMI)]. BRILINTA 60mg is indicated for the treatment of patients who have suffered a heart attack at least one-year prior and are at high risk of developing a further atherothrombotic event. Treatment with BRILINTA 60mg may be started as continuation therapy after an initial one-year treatment with BRILINTA 90mg and aspirin or other dual anti-platelet therapy.

BRILINTA has been shown to reduce the rate of a combined end point of CV death, MI, or stroke compared to clopidogrel. The difference between treatments was driven by CV death and MI with no difference in stroke. In patients treated with percutaneous coronary intervention, it also reduces the rate of stent thrombosis.

About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Respiratory, Cardiovascular & Metabolic Diseases, and Oncology. The Company is also selectively active in Neuroscience and Autoimmunity. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.

CONTACTS

Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and Metabolic Disease,

ING - Infection, Neuroscience and Gastrointestinal

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