March 25, 2014 — Patient enrollment has been completed four months ahead of plan in the Phase III clinical trial EUCLID study for AstraZeneca's ticagrelor (Brilinta) tablets. Part of PARTHENON, AstraZeneca’s largest clinical trial program, EUCLID has randomized more than 13,500 patients globally with peripheral artery disease (PAD); approximately 20 percent are patients in the United States from more than 300 active clinical trial sites across the country. EUCLID is designed to evaluate the effects of ticagrelor (monotherapy) compared to clopidogrel (monotherapy) on cardiovascular (CV) events and safety in PAD patients. Ticagrelor is currently not approved for the treatment of patients with PAD.
“We are very excited to have completed enrollment in the EUCLID study ahead of schedule. This study will provide important information regarding the use of oral antiplatelet agents in peripheral artery disease,” said EUCLID Study Chair William Hiatt, M.D., professor of medicine, division of cardiology, University of Colorado School of Medicine and CPC Clinical Research. “PAD affects approximately 202 million people globally and 8.5 million people in the U.S. Patients living with the disease are at high risk for developing myocardial infarctions, strokes, and other health complications.”
AstraZeneca also announced that U.S. recruitment and enrollment is underway in two additional Phase III PARTHENON studies – SOCRATES and THEMIS. SOCRATES (Acute Stroke Or Transient IsChaemic Attack TReated with Aspirin or Ticagrelor and Patient OutcomES) will evaluate the efficacy of ticagrelor compared to aspirin in reducing major vascular events in patients with acute ischemic stroke or transient ischemic attack (TIA). Ticagrelor is currently not approved for the treatment of patients with ischemic stroke or TIA.
THEMIS (Effect of Ticagrelor on Health Outcomes in DiabEtes Mellitus Patients Intervention Study) will evaluate the efficacy of ticagrelor vs placebo, on top of standard of care including aspirin, for the long-term prevention of major vascular events in patients with Type 2 diabetes and coronary atherosclerosis. Ticagrelor is not currently approved for the prevention of cardiovascular events in patients with diabetes and coronary atherosclerosis.
“Even with aspirin, more than 10 percent of patients who have had an acute ischemic stroke or transient ischemic attack will have a subsequent major stroke within 90 days. We strongly encourage physicians to refer appropriate patients for enrollment in the SOCRATES clinical trial, which will be investigating whether the use of ticagrelor in this patient population can help address a substantial unmet need,” said SOCRATES Study Co-Chair Clay Johnston, M.D., Ph.D., director, Clinical and Translational Science Institute, associate vice chancellor of research, University of California, San Francisco (UCSF).
“Of the approximately 26 million people in the US who suffer from diabetes, over 90 percent have Type 2 diabetes — and nearly two-thirds of them will die from cardiovascular disease,” said THEMIS Study Co-Chair Deepak L. Bhatt, M.D., MPH, executive director of interventional cardiovascular programs, Brigham and Women’s Hospital Heart and Vascular Center, and professor of medicine at Harvard Medical School. “The THEMIS study will explore the use of ticagrelor in patients with diabetes, and hopes to provide new scientific evidence to guide appropriate treatment for these high-risk patients, with all of their associated co-morbidities.”
EUCLID, SOCRATES, and THEMIS each have an Independent Data Monitoring Committee, which will review the safety and efficacy of treatments in these trials. The trials will be conducted in accordance with good clinical practice.
SOCRATES and THEMIS Now Enrolling
SOCRATES is designed to randomize 9,600 patients globally who have experienced an acute ischemic stroke or TIA, with approximately 200 U.S. clinical trial sites planned. It is a randomized, parallel group study evaluating the efficacy of ticagrelor compared to aspirin in reducing major cardiovascular events, defined as the composite of all-cause mortality, myocardial infarction (MI), and stroke in this patient population. Men or women 40 years of age or older who have experienced either acute ischemic stroke or high-risk TIA may qualify for randomization in this trial within 24 hours after onset of symptoms. Additional information about SOCRATES trial sites and/or patient enrollment is available at www.clinicaltrials.gov by searching under the term SOCRATES or by contacting [email protected]
THEMIS is designed to randomize 17,000 patients globally, with approximately 250 U.S. clinical trial sites planned. It is an event-driven, randomized, parallel group study evaluating the efficacy of long-term treatment with ticagrelor compared with placebo for the prevention of major CV events, defined as the composite of CV death, MI, or stroke with Type 2 diabetes, without a history of previous MI or stroke but with documented coronary atherosclerosis. Men or women 50 years of age or older with Type 2 diabetes who have been on treatment with a glucose-lowering medication for at least six months, and have either documented coronary artery occlusive disease or previous revascularization of a coronary artery, may qualify for participation in this trial. Additional information about THEMIS trial sites and/or patient enrollment is available at www.clinicaltrials.gov by searching under the term THEMIS or by contacting [email protected]
Interested physicians may also visit the AstraZeneca Cardiovascular Research booth (#3407) at the 2014 Annual American College of Cardiology Scientific Session in Washington, DC on March 29–31.
EUCLID (Examining Use of tiCagreLor In paD) recruited more than 13,500 patients globally, including patients from more than 300 active U.S. clinical trial sites. It 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. Ticagrelor is currently not approved for the treatment of patients with PAD.
AstraZeneca is currently collaborating with more than 4,000 clinical investigators in more than 30 countries as part of the PARTHENON program, and has established partnerships with a number of pre-eminent research institutions. In addition to EUCLID, SOCRATES and THEMIS, PEGASUS-TIMI 54 is another ongoing global study evaluating ticagrelor for the secondary prevention of CV events in patients with previous MI.
Ticagrelor is currently not approved for the treatment of patients with ischemic stroke, TIA, PAD, for the prevention of CV events in patients with diabetes and coronary atherosclerosis, or for secondary prevention in patients with a history of previous MI.