Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial 2 (INTERACT2)
Intracerebral haemorrhage (ICH) is one of the most serious types of stroke, affecting over a million people worldwide each year, most of whom live in Asia. About one third of people with ICH die early after onset and the majority of survivors are left with major, long-term disability.
Blood pressure levels are strongly associated with first and recurrent stroke, and high blood pressure is common after stroke, especially ICH. While there is strong evidence that BP lowering reduces stroke risk, the effect of BP lowering treatment in the early stage of ICH remains unknown. Despite the magnitude of the disease burden and cost on healthcare resources, there are currently no routine therapies that have been shown to definitely modify outcome in ICH.
This study has been completed but analyses are ongoing.
Results from the INTERACT pilot study showed that early intensive BP lowering treatment is safe and well tolerated and appeared to reduce bleeding in the brain by about 20-30%. The results are published in Lancet Neurology, May 2008. The INTERACT pilot study was followed by INTERACT2, the main phase.
To establish the effects of early intensive blood pressure lowering in patients with intracerebral haemorrhage (ICH).
INTERACT2 is a prospective, open label, multi-centre, randomized controlled trial involving 2800 patients with acute ICH recruited from approximately 140 centres in the world.
Eligible participants will be randomised to receive either intensive blood pressure lowering treatment (systolic BP < 140 mmHg), or conservative blood pressure management based on standard national or international guidelines, such as the current American Heart Association guidelines.
Participant recruitment for INTERACT2 began in October 2008. Approximately 140 centres from around the world are participating, including centres in Australia, Europe, China, India, Africa, and USA. Trial recruitment is due to be completed towards the end of 2011.
Clinical Research Associate: Bryan Holder