AstraZeneca announces initiation of two additional global studies for BRILINTA (ticagrelor)
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 troke r Transient Ishaemic Attack Teated with spirin or icagrelor and Patient Outcom) 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. Ischaemic 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 brainand is often considered a warning sign that a stroke may follow.
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 icagrelor on ealth Outcomes in Diabtes ellitus Patients ntervention tudy) 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-diabetes and approximately 90 per cent of those affected are Type 2.
"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 andTHEMIS 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.
Ticagrelor is an oral antiplatelet treatment for acute coronary
syndromes (ACS). Ticagrelor is a direct-acting P2Yreceptor 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.
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.
Heart & Stroke Foundation. Stroke Statistics. 2012. Available at:
http://www.heartandstroke.com/site/c.ikIQLcMWJtE/b.3483991/k.34A8/Statis.... Accessed 18 November 2013.
American Heart Association. Ischemic Strokes (Clots). Available at: http://www.strokeassociation.org/STROKEORG/AboutStroke/TypesofStroke/Isc.... Accessed 4 November 2013.
American 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.
Canadian Diabetes Association. About Diabetes. 2012. Available at: http://www.diabetes.ca/about-diabetes/what/prevalence/. Accessed 1 March 2013.
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.