Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage

The George Institute

Status

Completed

Conditions

Cerebral Hemorrhage

Intracranial Hemorrhages

CVA (Cerebrovascular Accident)

Treatments

Drug: Nicardipine

Drug: Phentolamine mesylate

Drug: Enalaprilat

Drug: Labetalol Hydrochloride

Drug: Urapidil

Drug: Esmolol

Drug: Glycerol Trinitrate

Drug: Hydralazine Hydrochloride

Drug: Nitroprusside

Drug: Clonidine

Drug: Metoprolol tartrate

Study type

Interventional

Funder types

Other

Identifiers

NCT00226096

NDA1INTERACT

Details and patient eligibility

About

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.

Full 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.

Enrollment

404 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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