AstraZeneca plans to conduct ticagrelor plus clopidogrel clinical trial for PAD

AstraZeneca (NYSE: AZN) 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. 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 not approved for the treatment of patients with PAD.    

"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 randomized, double-blind, parallel group, multi-center study evaluating the efficacy of ticagrelor (monotherapy) compared to clopidogrel (monotherapy) in reducing the primary endpoint - a composite of CV death, MI or ischemic stroke - in patients with PAD.

In the EUCLID study, symptomatic PAD patients who are 50 years of age or older will be randomized to receive either ticagrelor 90 mg twice daily or clopidogrel 75 mg once daily. Now that plans to initiate the study have been finalized, the EUCLID steering committee will begin the process of recruiting study investigators, clinical centers, and eventually patients. 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 organization affiliated with the Duke University School of Medicine, and CPC Clinical Research, an academic research organization affiliate of the University of Colorado.

Ticagrelor Clinical Program

The EUCLID study (Examining Use of tiCagreLor In paD) is part of the PARTHENON program, 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 CV events and death. The current PARTHENON program is designed to include more than 51,000 patients worldwide.

"Despite therapeutic advances, cardiovascular disease remains the number one cause of death worldwide," said Judith Hsia, MD, Executive Director Clinical Research, AstraZeneca. "The PARTHENON program is part of our commitment to understand and advance treatments for cardiovascular 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 PLATelet Inhibition and Patient Outcomes). Ongoing studies in PARTHENON will move beyond ACS, investigating the use of ticagrelor as monotherapy and in comparison to other oral antiplatelets. Results of the PARTHENON program will help clinicians better understand the science behind ticagrelor of the following studies:

• PEGASUS-TIMI 54 (PrEvention with TicaGrelor of SecondAry Thrombotic Events in High-RiSk Patients with Prior AcUte Coronary Syndrome - Thrombolysis In Myocardial Infarction Study Group): The PEGASUS study investigates the efficacy and safety of ticagrelor in the long-term prevention of recurrent ischemic events in patients with a history of MI beyond the currently approved 12-month treatment period. PEGASUS is a randomized, double-blind, parallel-group, international, multi-center study of approximately 21,000 patients across 31 countries. Patients are being randomized 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 (PHase the International Study of TicagreLor and Clinical Outcomes 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, randomized, parallel-group, multinational, Phase III, head-to-head outcomes study of approximately 800 patients.