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 modify 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 (ischaemic or haemorrhagic), and there is definitive evidence that BP lowering reduces stroke risk. BP levels are commonly elevated early after the onset of stroke, particularly after an ICH. However, the effect of BP lowering treatment in the acute phase of ICH remains unknown.

INTERACT1

INTERACT1 was conducted between 2005 and 2007 and recruited 404 patients from 44 sites in Australia, China and South Korea. This pilot study has established the feasibility of the protocol, safety of early intensive BP lowering, and has showed a tendency in reduction of haematoma expansion within 6 hours of onset of ICH. Findings have been published in Lancet Neurology, May 2008.

INTERACT2

The next step will be to translate the impact of BP lowering on patients’ outcome (death and disability). Therefore, INTERACT2 has been designed.

Methods

INTERACT2 is a prospective, open label and randomized controlled trial. Participants (older than 18 y) will be randomized within 6 hours of onset of ICH, to either intensive blood pressure lowering treatment (systolic BP < 140 mmHg), or conservative blood pressure management according to current American Heart Association guidelines.

INTERACT2 aims to recruit 2800 patients from approximately 140 centers around the world.

Outcomes

The efficacy of the treatment regime will be evaluated on the endpoints of death and dependency, physical function, health-related quality of life, recurrent stroke and other vascular events, days of hospitalisation, requirement for permanent residential care, and other serious adverse events.

Status/Results

The study will begin in 2008 and finish in 2011.

Institute Investigators

Senior Research Fellow

Senior Project Manager

  • Hugh Senior

Research Fellow/Project Manager

Senior Clinical Research Associate

  • Robyn Walsh

Clinical Research Associate

  • Swamy Chintapatla

Collaborators

China:

  • The George Institute, China
  • Professor Yining Huang, department of Neurology, Peking University First Hospital, Beijing, China
  • Professor Jiguang Wang, centre for Epidemiological Studies and Clinical Trials, Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai, China

Europe:

  • Doctor Christian Stapf, Lariboisi￨re Hospital, Paris, France

Funding