Clinical trial in China to test whether early blood pressure reduction improves stroke outcomes

October 31, 2005

A large clinical trial called INTERACT, launched in China this month, will determine the effects of early intensive blood pressure lowering on death and disability in stroke patients. The INTERACT trial aims to provide reliable evidence about what is the optimal approach to managing blood pressure after intra-cerebral haemorrhage.

Intra-cerebral haemorrhage is one of the most serious forms of stroke, affecting 2-3 million people worldwide each year. Most of these live in China and surrounding Asian countries, and about one third will die a few days after onset. Of those that survive, the majority will face major long-term disabilities.

The George Institute's Professor Craig Anderson, who is the Principal Investigator in the trial, explained that "Chinese people appear to be at particularly high risk of intra-cerebral haemorrhage. This is partly due to the high prevalence of high blood pressure in the population and possibly to genetic factors.

"Despite the magnitude of the burden imposed by this disease, and the high cost to health services, there is no widely available treatment for the condition. However, early rapid blood pressure lowering shows considerable promise as a widely applicable, cost-effective therapy that can be readily incorporated into clinical practice," noted Prof Anderson. Although surgery is sometimes used in patients with severe intra-cerebral haemorrhage to relieve pressure on the brain, a recently published large-scale clinical trial has cast doubt over which patients most benefit from surgery.

In another approach to treatment, early administration of a laboratory-developed clotting factor, called activated recombinant human Factor VII (NovoSeven®), has been shown to limit expansion of bleeding in the brain and improve recovery in an international clinical trial that was published in the New England Journal of Medicine early this year. However, future use of this agent in clinical practice will be limited by the narrow time window for use after stroke onset, avoidance of its use in patients at high risk of clotting, and it's expense.

"Blood pressure is commonly elevated, sometimes to very high levels, after the onset of intra-cerebral haemorrhage and there is some evidence to suggest that lowering blood pressure levels improves outcomes" according to Professor Huang Yining, Co-Principal Investigator for INTERACT in China, and Professor of Neurology, Peking University First Hospital.

"The study will establish the safety and effects of a management policy of early intensive blood pressure lowering on death and disability, compared to current less intensive, guideline-based management of blood pressure in this clinical setting", said Professor Huang.
-end-
To obtain further details on the INTERACT trial, or to arrange interviews, contact:
In China
Dorothy Han, Senior Project Manager, The George Institute for International Health,
ph: +8610 8280 5056, fax: +8610 8280 2504, mobile: +86 139 1066 9903,
email: dorothyh2002@vip.sina.com or dhan@thegeorgeinstitute.org

In Australia:
Paul Davies, Public Affairs Manager, The George Institute for International Health
ph: +612 9993 4510, mobile: 0404 454 165, email: pdavies@thegeorgeinstitute.org
or visit The George Institute website at www.thegeorgeinstitute.org.

Notes for Editors:

INTERACT (INTENSIVE BLOOD PRESSURE REDUCTION IN ACUTE CEREBRAL HAEMORRHAGE TRIAL) is an international, multi-centre, randomised controlled trial involving 400 patients with acute intracerebral haemorrhage to be recruited from over 60 Clinical Centres in China, Southern Asia, Australia, New Zealand and the United States. Some 40 Chinese clinical sites are participating in the study, mainly in hospitals in Beijing and Shanghai.

The study is internationally coordinated by the George Institute for International Health (Professor Craig Anderson, Principal Investigator) in collaboration with coordinating centres in Beijng (Professor Huang Yining, Peking University First Hospital) and Shanghai (Professor Wang Jiguang, Shanghai Institute of Hypertension).

Professor Craig Anderson is Director of the Neurological and Mental Health Division at The George Institute. He is also Professor of Stroke Medicine and Clinical Neuroscience in the Faculty of Medicine at the University of Sydney and the Institute of Neurosciences of Royal Prince Alfred Hospital. He is a member of several specialist societies, is an Editor for the Cochrane Stroke Group, and is currently President of the Stroke Society of Australasia.

Craig has published widely on the clinical and epidemiological aspects of stroke, cardiovascular disease and aged care, and is on the Steering Committee for several large-scale research projects including the Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial (ONTARGET) global trials program in cardiovascular prevention involving over 30,000 patients in 40 countries. He will be available during Stroke Week.

The George Institute for International Health seeks to gather evidence to address the growing problems of heart and vascular disease, injury, mental illness and neurological diseases through high-quality research, evidence-based policy development and a range of capacity development programs.

Recognising the significant health burdens associated with the ever increasing numbers of older people around the world, The George Institute established the Neurological and Mental Health Division with the aims of developing new strategies for the prevention, treatment and rehabilitation of neurological diseases and related disorders that predominantly affect older people, namely stroke, dementia, depression and frailty. In addition to complimentary activities with the other Divisions of The George Institute, the Neurological and Mental Health Division is collaborating with neuroscience and health research institutes in Australia and overseas.

Research Australia

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