• A composite of death or dependency, with dependency being defined by a score of 3 to 5 on the modified Rankin Scale (mRS) [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  

• death and dependency in patients treated <4 hours; death; dependency; HRQoL; physical function; recurrent vascular events; days of hospitalisation; permanent residential care [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  

Intracerebral haemorrhage (ICH) is one of the most serious subtypes 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 INTERACT2 study follows the recently completed initial pilot study vanguard phase) which established the feasibility of the protocol, safety of early intensive BP lowering, and effects on haematoma expansion within 6 hours of onset of ICH. Having established 'proof-of-concept' that BP lowering may improve outcome by reducing haematoma expansion, INTERACT2 aims to establish the effects of the treatment on major clinical endpoints in patients with ICH recruited from an expanding clinical network around the world.