Overview

Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage

Status:
Completed
Trial end date:
2007-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The George Institute
Collaborator:
National Health and Medical Research Council, Australia
Treatments:
Clonidine
Enalaprilat
Esmolol
Glycerol
Hydralazine
Labetalol
Metoprolol
Nicardipine
Nitroglycerin
Nitroprusside
Phentolamine
Urapidil
Criteria
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 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