AstraZeneca announces initiation of two additional global studies for BRILINTA (ticagrelor)

SOCRATES compares ticagrelor versus aspirin for the prevention of major vascular events in patients with acute ischaemic stroke or transient ischaemic attack

THEMIS compares ticagrelor versus placebo for the long-term prevention of major vascular events in patients with Type 2 diabetes at high cardiovascular risk

MISSISSAUGA, ON, Dec. 5, 2013 /CNW/ - AstraZeneca has announced plans to conduct two new Phase IIIb clinical studies as part of PARTHENON, the company's largest clinical trial programme involving over 80,000 patients, with Canada actively participating in both studies. The studies are designed to build scientific understanding of BRILINTA^® (ticagrelor) tablets in additional high-risk patient populations.

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 ischaemic stroke or transient ischaemic attack (TIA). Annually, 50,000 Canadians suffer a stroke. It is the third leading cause of death in Canada.¹ Ischaemic strokes occur as a result of an obstruction of a vessel supplying blood to the brain.² 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. ³

SOCRATES is a randomised, parallel group study evaluating the efficacy of ticagrelor compared to aspirin in reducing major vascular events (composite of all-cause mortality, non-fatal myocardial infarction, and non-fatal stroke) in patients with acute ischaemic stroke (NIHSS < 5).

"The short-term stroke risk after a TIA and minor ischaemic stroke is extremely high, with more than 10 per cent of patients having a major stroke within 90 days; and this is with aspirin. We need better medicines in this setting and SOCRATES will tell us whether ticagrelor might be such a medicine," said Clay Johnston, MD, PhD Director, Clinical and Translational Science Institute, Associate Vice Chancellor of Research, University of California, San Francisco.

THEMIS (Effect of Ticagrelor on Health Outcomes in DiabEtes Mellitus Patients Intervention Study) is a global clinical trial involving 17,000 patients with Type 2 diabetes at high risk of cardiovascular events. More than nine million Canadians are currently living with diabetes or pre-diabetes⁴ and approximately 90 per cent of those affected are Type 2.⁵

"A major goal for 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 is an event-driven, randomised, parallel group study comparing the efficacy of long-term treatment with ticagrelor versus placebo for the prevention of major cardiovascular events (composite of cardiovascular death, myocardial infarction or stroke) in patients with Type 2 diabetes without a history of previous myocardial infarction or stroke, but with documented coronary atherosclerosis. Study patients will receive ticagrelor 90 mg twice daily versus placebo and will be managed according to local standards of care, including provision of dietary and lifestyle advice according to local diabetes treatment guidelines. Use of low-dose aspirin once daily is permitted if clinically indicated, as judged by the investigator.

"THEMIS will allow us to test a 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.

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 programme, and has established partnerships with a number of pre-eminent research institutions. Other studies in the PARTHENON programme include PEGASUS, studying ticagrelor for secondary prevention in patients with previous myocardial infarction, and EUCLID studying patients with Peripheral Artery Disease.

PARTHENON will provide a huge dataset to build scientific understanding of ticagrelor in a broad a range of atherothrombotic conditions.

Ticagrelor is currently not approved for the treatment of patients with ischaemic stroke, Peripheral Artery Disease, or for secondary prevention in patients with a history of previous myocardial infarction going back more than one year.

NOTES TO EDITORS

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). Regarding possible interactions and side effects, please see full prescribing information.

On May 30, 2011, Health Canada approved ticagrelor, co-administered with acetylsalicylic acid (ASA) (maintenance dose 75-150mg daily) for the secondary prevention of atherothrombotic events in adult patients with Acute Coronary Syndromes (ACS) (unstable angina [UA], non ST elevation Myocardial Infarction [NSTEMI] or ST elevation Myocardial Infarction [STEMI]) who are to be managed medically and those who are to be managed with percutaneous coronary intervention (PCI) (with or without stent) and/or coronary artery bypass graft (CABG).

Ticagrelor is approved in 100 countries, including Canada, United States, Brazil, Australia and Russia under the trade name BRILINTA as well as in the European Union under the trade name BRILIQUE.

BRILINTA and BRILIQUE are trademarks of the AstraZeneca group of companies. For detailed information regarding ticagrelor in your area, please refer to the local prescribing information.

About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization 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. AstraZeneca's Canadian headquarters are located in Mississauga, Ontario. For more information, please visit the company's website at www.astrazeneca.ca.

¹ Heart & Stroke Foundation. Stroke Statistics. 2012. Available at:
http://www.heartandstroke.com/site/c.ikIQLcMWJtE/b.3483991/k.34A8/Statistics.htm#stroke. Accessed 18 November 2013.
² American Heart Association. Ischemic Strokes (Clots). Available at: http://www.strokeassociation.org/STROKEORG/AboutStroke/TypesofStroke/IschemicClots/Ischemic-Strokes-Clots_UCM_310939_Article.jsp. Accessed 4 November 2013.
³American Heart Association. Transient Attack. Available at: http://www.strokeassociation.org/STROKEORG/AboutStroke/TypesofStroke/TIA/TIA-Transient-Ischemic-Attack_UCM_310942_Article.jsp.  Accessed 4 November 2013.
⁴ Canadian Diabetes Association. About Diabetes. 2012. Available at: http://www.diabetes.ca/about-diabetes/what/prevalence/. Accessed 1 March 2013.
⁵ Canadian Diabetes Association. Diabetes Facts. 2012. Available at: http://www.diabetes.ca/diabetes-and-you/what/facts/. Accessed 1 March 2013.

SOURCE: AstraZeneca Canada Inc.

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