Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial - INTERACT
The INTERACT pilot study is followed by INTERACT2, the main phase.
Aims
INTERACT aims to determine if early intensive blood pressure lowering therapy can reduce death and disability from intracerebral haemorrhage.
Methods
The study is an open, blinded-endpoint, randomised controlled trial conducted in Australia, New Zealand, China, the USA and Korea. Three thousand (3,000) participants within six hours of acute intracerebral haemorrhage onset are required for the main study. Participants will be randomised to either early intensive blood pressure lowering, or blood pressure management according to current American Heart Association guidelines. Follow-up will be for three months.
Before the main study is conducted, a vanguard phase, involving 400 patients from 60 clinical centres in Australia, New Zealand, China, the USA and Korea is currently underway to obtain epidemiological and feasibility data. The primary outcomes of the pilot study are to:
- Define recruitment rates
- Confirm that blood pressure reduction is possible
- Establish haematoma expansion rates at 0-6 hours
- Quantify outcome event rates
- Show safety
- Characterise background care
- Evaluate adherence to follow-up
Status/Results
Planning for the study began in 2004. Results of the vanguard phase were released in early 2008. Recruitment for the main phase of the study is scheduled to commence in 2008.
Institute Investigators
- Craig Anderson (Principal Investigator)
- John Chalmers
- Bruce Neal
- Stephen MacMahon
- Mark Woodwood
- Emma Heeley
- Hugh Senior
- Tian Erho
Collaboration
- National Stroke Research Institute, Melbourne, Australia
- The Greater Metropolitan Clinical Taskforce, Sydney, Australia
- Australasian Stroke Trials Network, Australia
- Hunter Stroke Service, New South Wales, Australia
- Department of Neurology, Peking University First Hospital, Beijing, China
- Centre for Epidemiological Studies and Clinical Trials, Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai, China
- Stroke Program, University of Michigan, Medical School, USA
- Collaborative Studies Coordinating Center, Department of Biostatistics, University of North Carolina, Chapel Hill, USA