Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage
Information source: The George Institute
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: CVA (Cerebrovascular Accident); Cerebral Hemorrhage; Intracranial Hemorrhages
Intervention: 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 (Drug)
Phase: N/A
Status: Completed
Sponsored by: The George Institute Official(s) and/or principal investigator(s):
Craig Anderson, PhD, Principal Investigator, Affiliation: The George Institute
Bruce Neal, PhD, Principal Investigator, Affiliation: The George Institute
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.
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Combination death and dependency, according to a 3-6 scores on the modified Rankin Score.
Secondary outcome: All cause and cause-specific early neurological deterioration during the first 72 hours; haematoma expansion & cerebral oedema at 24 & 72 hours; ; functional disability; cognitive function; quality of life; mortality at 1 and 3 months
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Hospitals in China, c/o The George Institute China, Beijing, China
Regional Coordinating Centre: Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai Institute of Hypertension, Shanghai Second Medical University, Shanghai 200025, China
Regional Coordinating Centre: Peking University First Hospital, Beijing 100034, China
Christchurch Hospital, Christchurch, New Zealand
North Shore Hospital, Auckland, New Zealand
Royal Prince Alfred Hospital, Sydney, New South Wales 2050, Australia
St George Hospital, Kogarah, New South Wales 2217, Australia
Concord Hospital, Concord, New South Wales 2138, Australia
John Hunter Hospital, Newcastle, New South Wales 2310, Australia
Westmead Hospital, Westmead, New South Wales 2145, Australia
St Vincent's Hospital, Sydney, New South Wales 2010, Australia
Gosford Hospital, Gosford, New South Wales 2250, Australia
Royal Adelaide Hospital, Adelaide, South Australia 5000, Australia
Box Hill Hospital, Melbourne, Victoria 3128, Australia
Austin Health, Melbourne, Victoria, Australia
Royal Melbourne Hospital, Melbourne, Victoria 3050, Australia
Alfred Hospital, Melbourne, Victoria 3181, Australia
St Vincent's Hospital, Melbourne, Victoria 3065, Australia
Monash Medical Centre, Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital, Perth, Western Australia 6009, Australia
Additional Information
Starting date: November 2005
Ending date: September 2007
Last updated: March 10, 2008
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