NCT00226096

Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage

A Randomised Trial to Establish the Effects of Early Intensive Blood Pressure Lowering on Death and Disability in Patients With Stroke Due to Acute Intracerebral Haemorrhage

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 404 (actual)
• Sponsor: The George Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine whether lowering high blood pressure levels after the start of a stroke caused by bleeding in the brain (intracerebral haemorrhage) will reduce the chances of a person dying or surviving with a long term disability. The study will be undertaken in two phases: a vanguard phase in 400 patients, to plan for a main phase in 2000 patients.

Detailed description

Intracerebral haemorrhage (ICH) is one of the most serious subtypes of stroke, affecting approximately 2-3 million people worldwide each year. About one third of people with ICH die early after onset and the majority of survivors are left with major long-term disability. Administration of activated recombinant human Factor VII has been shown to limit haematoma expansion in randomised controlled clinical trials; however, future clinical use of this agent may be limited by a short therapeutic time window, contraindication in patients at risk of thromboembolism and high cost. Currently, no acute medical therapies have been shown to alter outcome in ICH and the role of surgery remains uncertain. Blood pressure (BP) levels are strongly and positively associated with the incidence of first and recurrent stroke and there is definite evidence that BP lowering reduces stroke risk. Although BP levels are commonly elevated after stroke onset, particularly in ICH, the effects of BP lowering treatment in the acute phase of stroke remain unknown. The study aims to establish the effectiveness of a management policy of early intensive BP lowering on death \& disability in patients with primary ICH compared to current guideline-based management of high BP in the clinical setting.

Conditions

• CVA (Cerebrovascular Accident)
• Cerebral Hemorrhage
• Intracranial Hemorrhages

Interventions

Type	Name	Description
DRUG	Labetalol Hydrochloride
DRUG	Metoprolol tartrate
DRUG	Hydralazine Hydrochloride
DRUG	Glycerol Trinitrate
DRUG	Phentolamine mesylate
DRUG	Nicardipine
DRUG	Urapidil
DRUG	Esmolol
DRUG	Clonidine
DRUG	Enalaprilat
DRUG	Nitroprusside

Timeline

• Start date: 2005-11-01
• Primary completion: 2007-09-01
• Completion: 2007-09-01
• First posted: 2005-09-26
• Last updated: 2008-06-26

Locations

20 sites across 3 countries: Australia, China, New Zealand