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Clinical Trials
NCT00226096

Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage

Last Updated: 2008-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

Total Enrollment

404 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-09-30

Brief Summary

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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

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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

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CVA (Cerebrovascular Accident) Cerebral Hemorrhage Intracranial Hemorrhages

Keywords

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Clinical Trial Blood Pressure CVA (Cerebrovascular Accident)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Labetalol Hydrochloride

Intervention Type DRUG

Metoprolol tartrate

Intervention Type DRUG

Hydralazine Hydrochloride

Intervention Type DRUG

Glycerol Trinitrate

Intervention Type DRUG

Phentolamine mesylate

Intervention Type DRUG

Nicardipine

Intervention Type DRUG

Urapidil

Intervention Type DRUG

Esmolol

Intervention Type DRUG

Clonidine

Intervention Type DRUG

Enalaprilat

Intervention Type DRUG

Nitroprusside

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Aged 18 years or above
* Acute stroke due to spontaneous ICH confirmed by clinical history \& CT scan
* At least 2 systolic BP measurements of \>/=150mmHg and \</=220mmHg, recorded 2 or more minutes apart
* Able to commence randomly assigned BP lowering regimen within 6 hours of stroke onset
* Able to be actively treated and admitted to a monitored facility e.g. HDU/ICU/acute stroke unit

Exclusion Criteria

* Known definite contraindication to an intensive BP lowering regimen
* Known definite indication for intensive BP lowering regimen as (or more) intensive than the active treatment arm
* Definite evidence that the ICH is secondary to a structural abnormality in the brain
* 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
* Known advanced dementia or significant pre-stroke disability
* Concomitant medical illness that would interfere with outcome assessments and follow up
* Already booked for surgical evacuation of haematoma
* Previous participation in this trial or current participation in another investigational drug trial
* A high likelihood that the patient will not adhere to the study treatment and follow up regimen

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Principal Investigators

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Craig Anderson, PhD

Role: PRINCIPAL_INVESTIGATOR

The George Institute

Bruce Neal, PhD

Role: PRINCIPAL_INVESTIGATOR

The George Institute

Locations

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Concord Hospital

Concord, New South Wales, Australia

Site Status

Gosford Hospital

Gosford, New South Wales, Australia

Site Status

St George Hospital

Kogarah, New South Wales, Australia

Site Status

John Hunter Hospital

Newcastle, New South Wales, Australia

Site Status

St Vincent's Hospital

Sydney, New South Wales, Australia

Site Status

Royal Prince Alfred Hospital

Sydney, New South Wales, Australia

Site Status

Westmead Hospital

Westmead, New South Wales, Australia

Site Status