The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial - INTERACT2

Background

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.

Despite the magnitude of the disease burden and cost on healthcare resources, there remains uncertainty about the role of surgery for ICH and no acute medical therapies have been shown to definitely alter outcome in ICH. The management of ICH, therefore, contrasts sharply with that of ischaemic stroke, where there is now strong evidence to support the routine use of thrombolysis in carefully selected patients, and aspirin in the majority.

Blood pressure (BP) levels are strongly and positively associated with the incidence of first and recurrent stroke, and there is definitive evidence that BP lowering reduces stroke risk. Although BP levels are commonly elevated early after the onset of stroke, particularly in ICH, the effects of BP lowering treatment in the acute phase of stroke remain unknown. As a consequence, there are wide ranging guideline recommendations for the management of elevated BP in the setting of acute ICH. While these provide an indication of perceived harm associated with ‘very high’ BP levels (>22mmHg), they also highlight persisting clinical uncertainty about what comprises optimal management of BP in this patient group.

Aims

INTERACT2 aims to investigate whether early intensive blood pressure lowering therapy can reduce death and disability from intracerebral haemorrhage compared to a conservative management that is based on a current guideline for the management of intracerebral haemorrhage in clinical settings.

Methods

INTERACT2 is a multi-centre, prospective, open label, randomized controlled tiral that aims to recruit 2800 patients (age 18 years and over) with acute ICH within 6 hours onset from approximately 140 sites around the world. Participants will be randomized to either early intensive blood pressure lowering, or blood pressure management according to current American Heart Association guidelines. Clinical outcomes will be assessed over 90 days.

Status/Results

The study will begin in 2008 and finish in 2011. A pilot study - INTERACT - recruited 404 patients from 44 sites in Australia, China and South Korea and was conducted during 2005-2007. Findings have been published in Lancet Neurology, May 2008. Results show that early intensive BP lowering treatment is well tolerated and appears to attenuate the growth of hematoma in ICH. These data provide a strong basis for proceeding with INTERACT2.

Institute Investigators

Project Manager

  • Tian Erho

Collaborators

Funding