The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial

Not Applicable

Completed

• Conditions: Hypertension; Stroke; Intracerebral Hemorrhage

• Registration Number: NCT00716079
• Lead Sponsor: The George Institute

Brief 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.

Study Timeline

• Study First Submitted: 2008-07-14
• Study First Submitted QC: 2008-07-14
• Study First Posted: 2008-07-16
• Study Start: 2008-09
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2013-08-21
• Results First Submitted QC: 2013-08-21
• Results First Posted: 2013-10-28
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-19
• Last Update Posted: 2013-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2839

Inclusion Criteria

• Patients with CT-confirmed spontaneous Intracerebral Haemorrhage (ICH)
• Elevated systolic blood pressure (>150mmHg and <220mmHg)
• Capacity to commence randomly assigned treatment within 6 hours of onset of ICH.
• Able to be 'actively' treated and admitted to a monitored facility

Exclusion Criteria

• Clear indication or contraindication to intensive BP lowering.
• Evidence ICH secondary to a structural abnormality
• Use of thrombolytic agent
• Previous ischaemic stroke within 30 days
• A very high likelihood that the patient will die within the next 24 hours on the basis of clinical and/or radiological criteria
• Score of 3-5 on the Glasgow Coma Scale (indicating deep coma)
• Significant pre-stroke disability or advanced dementia
• Planned early neurological intervention
• Participation in another clinical trial.
• A high likelihood that the patient will not adhere to the study treatment and follow-up regimen.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
A Composite of Death or Dependency, With Dependency Being Defined by a Score of 3 to 5 on the Modified Rankin Scale (mRS)	90 days

Secondary Outcome Measures

Name	Time	Method
Death at 90 Days	90 days

Trial Locations

Locations (62)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Regional Coordinating Centre Argentina; 🇦🇷 Buenos Aires, Argentina

Canberra Hospital; 🇦🇺 Canberra, Australian Capital Territory, Australia

Concord Hospital; 🇦🇺 Concord, New South Wales, Australia

Gosford Hospital; 🇦🇺 Gosford, New South Wales, Australia

John Hunter Hospital; 🇦🇺 Newcastle, New South Wales, Australia

Royal Prince Alfred Hospital; 🇦🇺 Sydney, New South Wales, Australia

Royal Brisbane and Women's Hospital Health Service District; 🇦🇺 Brisbane, Queensland, Australia

Western Hospital; 🇦🇺 Melbourne, Victoria, Australia

Royal Melbourne Hospital; 🇦🇺 Melbourne, Victoria, Australia

Scroll for more (52 remaining)