The SOCRATES study compares ticagrelor versus aspirin for the prevention of major vascular events in patients with acute ischemic stroke or transient ischemic attack [1,2].
SOCRATES (Acute Stroke Or Transient IsChaemic Attack TReated with Aspirin or Ticagrelor and Patient OutcomES) is a global clinical trial involving 9,600 patients who have experienced an acute ischemic stroke or transient ischemic attack (TIA). Annually, 15 million people worldwide suffer a stroke of this type. Ischemic strokes occur as a result of an obstruction of a vessel supplying blood to the brain. A TIA is secondary to a temporary insufficient blood supply to parts of the brain and is often considered a warning sign that a stroke may follow.
SOCRATES is a randomized, parallel group study evaluating the efficacy of ticagrelor compared to aspirin in reducing major vascular events (composite of all-cause mortality, myocardial infarction [MI], and stroke) in patients with acute ischemic stroke (NIHSS ≤ 5) and TIA.
Also announced today is the initiation of THEMIS (Effect of Ticagrelor on Health Outcomes in DiabEtes Mellitus Patients Intervention Study), a global clinical trial involving 17,000 patients with Type 2 diabetes at high risk of cardiovascular (CV) events. Of the 340 million people who suffer from the disease, 90 percent have type 2 diabetes and 50 percent of whom die from CV disease.
“A major goal of treating patients with diabetes is to reduce their cardiovascular risk,” said THEMIS study co-chair Deepak L. Bhatt, MD, MPH, Professor of Medicine at Harvard Medical School and Senior Physician at Brigham and Women’s Hospital.
“THEMIS will allow us to test a bold new strategy in the care of patients with diabetes who are at high risk of myocardial infarction, stroke, and cardiovascular death,” stated THEMIS study co-chair Ph. Gabriel Steg, MD, Professor of Medicine at Université Paris-Diderot and Director of the Coronary Care Unit at Hôpital Bichat.
THEMIS is an event-driven, randomized, parallel group study evaluating the efficacy of long-term treatment with ticagrelor versus placebo for the prevention of major CV events – the composite of CV death, MI or stroke – in patients with Type 2 diabetes without a history of previous MI or stroke but with documented coronary atherosclerosis.
SOCRATES and THEMIS will be monitored by Independent Data Monitoring Committees who will review the safety and efficacy of treatments in these trials. The trials will be conducted in accordance with Good Clinical Practice. Both studies will be posted on clinicaltrials.gov in the near future.
AstraZeneca is currently collaborating with over 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. Other studies in the PARTHENON program include PEGASUS, studying BRILINTA for secondary prevention in patients with previous myocardial infarction, and EUCLID studying patients with Peripheral Artery Disease.
PARTHENON will provide an unparalleled dataset to build scientific understanding of BRILINTA in a broad a range of atherothrombotic conditions. AstraZeneca has approved more than 100 investigator sponsored studies, which will be starting during the coming year.
BRILINTA is currently not approved for the treatment of patients with ischemic stroke, TIA, peripheral artery disease, or for secondary prevention in patients with a history of previous myocardial infarction.
BRILINTA is indicated to reduce the rate of thrombotic cardiovascular (CV) events in patients with ACS (unstable angina [UA], non–ST-elevation myocardial infarction [NSTEMI], or ST-elevation myocardial infarction [STEMI]). In PLATO, BRILINTA has been shown to reduce the rate of a combined end point of CV death, myocardial infarction (MI), or stroke compared to clopidogrel. In PLATO, the difference between treatments was driven by CV death and MI with no difference in stroke. In patients treated with an artery-opening procedure known as percutaneous coronary intervention (PCI), BRILINTA reduces the rate of stent thrombosis.
BRILINTA has been studied in ACS in combination with aspirin. Maintenance doses of aspirin above 100 mg decreased the effectiveness of BRILINTA. Avoid maintenance doses of aspirin above 100 mg daily.
1.Giacalone G, Abbas MA, Corea F. Prevention strategies for cardioembolic stroke: present and future perspectives. Open Neurol J. 2010; 4:56-63. doi: 10.2174/1874205X01004020056.
2.Silvestrelli G, Corea F, Micheli S, Lanari A. Clinical pharmacology and vascular risk.Open Neurol J. 2010;4:64-72. doi: 10.2174/1874205X01004020064.