AstraZeneca to Initiate a New Study of BRILINTA (Ticagrelor) in Patients with PAD

EUCLID trial to compare ticagrelor to clopidogrel with respect to cardiovascular death, myocardial infarction and ischaemic stroke in patients with peripheral artery disease

AstraZeneca today announced plans to conduct the EUCLID study, a global clinical trial involving 11,500 patients with peripheral artery disease (PAD), a condition affecting approximately 27 million people in Europe and North America.¹ PAD patients are at high risk of myocardial infarction (MI), strokes, and other health complications. EUCLID is designed to evaluate cardiovascular (CV) event rate and safety in PAD patients. Ticagrelor is currently only approved for the prevention of cardiovascular events in patients with Acute Coronary Syndromes (ACS).

“The global burden of PAD is such that it necessitates further research of additional treatment options that may further reduce the risk of atherothrombotic CV events and CV death,” said William Hiatt, MD, Professor of Medicine, Division of Cardiology, University of Colorado School of Medicine. “The EUCLID study is an exciting clinical trial, as it may provide further clinical evidence regarding the role oral antiplatelets can play in reducing risk for patients with PAD.”

EUCLID is a randomised, double-blind, parallel group, multi-centre study evaluating the efficacy of ticagrelor (monotherapy) compared to clopidogrel (monotherapy) in reducing the primary endpoint – a composite of CV death, MI or ischaemic stroke – in patients with PAD.

In the EUCLID study, symptomatic PAD patients who are 50 years of age or older will be randomised to receive either ticagrelor 90 mg twice daily or clopidogrel 75 mg once daily. Now that plans to initiate the study have been finalised, the process of recruiting study investigators, clinical centres, and eventually patients will begin. Dr. Hiatt is the principal investigator for the EUCLID study, which is being conducted in partnership with the Duke Clinical Research Institute, an academic research organisation affiliated with the Duke University School of Medicine, and CPC Clinical Research, an academic research organisation affiliate of the University of Colorado.

Ticagrelor Clinical Programme

The EUCLID study (E xamining U se of tiC agreL or I n paD ) is part of the PARTHENON programme, an AstraZeneca-funded comprehensive, long-term and evolving global research initiative designed to address unanswered questions in atherothrombotic disease, and to investigate the impact of ticagrelor on reducing CV events and death. The current PARTHENON programme is designed to include more than 51,000 patients worldwide.

“Despite therapeutic advances, CV disease remains the number one cause of death worldwide,” said Judith Hsia, MD, Executive Director Clinical Research, AstraZeneca. “The PARTHENON programme is part of our commitment to understand and advance treatments for CV diseases in an effort to improve patient health. The benefit of ticagrelor on CV thrombotic events, including CV mortality, observed in patients who have had an ACS event supports continued study in other areas of cardiovascular disease.”

The first clinical study of PARTHENON was PLATO (A Study of PLAT elet Inhibition and Patient O utcomes). Ongoing studies in PARTHENON will move beyond acute coronary syndromes (ACS), investigating the use of ticagrelor as monotherapy and in comparison to other oral antiplatelets. Results of the PARTHENON programme will help clinicians better understand the science behind ticagrelor in the following studies:

• PEGASUS-TIMI 54 (P rE vention with TicaG relor of SecondA ry Thrombotic Events in High-RiS k Patients with Prior AcU te Coronary S yndrome – T hrombolysis I n M yocardial I nfarction Study Group): The PEGASUS study investigates the efficacy and safety of ticagrelor in the long-term prevention of recurrent ischaemic events in patients with a history of MI beyond the currently approved 12-month treatment period. PEGASUS is a randomised, double-blind, parallel-group, international, multi-centre study of approximately 21,000 patients across 31 countries. Patients are being randomised to either a 90 mg dose or 60 mg dose of ticagrelor BID or placebo. In addition to assigned study drug, patients will take once-daily, concomitant aspirin therapy (75 to 100 mg).
• PHILO (PH ase the I nternational Study of TicagreL or and Clinical O utcomes in Asian ACS Patients): The PHILO study will evaluate the impact of ticagrelor versus clopidogrel, both administered in combination with low-dose aspirin, on CV outcomes in Japanese and other Asian patients with ACS and planned for PCI. PHILO is a double-blind, randomised, parallel-group, multinational, Phase III, head-to-head outcomes study of approximately 800 patients.

Information about the PARTHENON programme and design of specific studies will be available at the European Society of Cardiology Congress (ESC), 25-29 August, in Munich, Germany. Further studies within the PARTHENON programme and updates regarding ongoing trials will be announced in due course.

NOTES TO EDITORS

About Peripheral Artery Disease

PAD is caused by atherosclerotic plaques that narrow the arteries in the legs and can lead to leg pain with walking. Patients with PAD have atherosclerosis in other arteries, increasing their risk of myocardial infarction, stroke and cardiovascular death.² Severe cases of PAD can also lead to critical or acute limb ischaemia with unhealed sores or infections on the legs or feet, resulting in tissue death, gangrene, and ultimately amputation of the infected limb. ³

About ticagrelor

Ticagrelor is an oral antiplatelet treatment for acute coronary syndromes (ACS). Ticagrelor is a direct-acting P2Y₁₂ receptor antagonist in a new chemical class called cyclopentyltriazolopyrimidines (CPTPs).

Ticagrelor is approved in 79 countries, including in the European Union under the trade name BRILIQUE and in the United States, Canada, Brazil, Australia and Russia under the trade name BRILINTA.

BRILINTA and BRILIQUE are trademarks of the AstraZeneca group of companies. For detailed information regarding ticagrelor, please refer to the local Summary of Product Characteristics.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. 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 .

¹ Belch, J. et. al. Peripheral arterial disease – a cardiovascular time bomb. British Journal of Diabetes and Vascular Disease 2007;7: 236-239.

² Mayo Foundation for Medical Education and Research: http://www.mayoclinic.com/health/peripheral-arterial-disease/

³ Mayo Foundation for Medical Education and Research: http://www.mayoclinic.com/health/peripheral-arterial-disease/

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