NCT00716079

The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial

An International Randomised Controlled Trial to Establish the Effects of Early Intensive Blood Pressure Lowering in Patients With Intracerebral Haemorrhage.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,839 (actual)
• Sponsor: The George Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this academic lead study is to determine if a treatment strategy of early intensive blood pressure (BP) lowering compared to conservative BP lowering policy in patients with elevated blood pressure within 6 hours of acute intracerebral haemorrhage (ICH) improves the outcome of death and disability at 3 months after onset.

Detailed description

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.

Conditions

• Intracerebral Hemorrhage
• Stroke
• Hypertension

Interventions

Type	Name	Description
OTHER	Blood pressure management policies	The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets.

Timeline

• Start date: 2008-09-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2008-07-16
• Last updated: 2013-12-13
• Results posted: 2013-10-28

Locations

62 sites across 19 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Finland, France, Germany, Hong Kong, India, Italy, Pakistan, Portugal, Spain, Switzerland, United Kingdom