Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00226096
Recruitment Status : Completed
First Posted : September 26, 2005
Last Update Posted : June 26, 2008
National Health and Medical Research Council, Australia
Information provided by:
The George Institute

September 23, 2005
September 26, 2005
June 26, 2008
November 2005
September 2007   (Final data collection date for primary outcome measure)
Combination death and dependency, according to a 3-6 scores on the modified Rankin Score. [ Time Frame: 3 months ]
Combination death and dependency, according to a 3-5 score on the mRS, at 3 months
Complete list of historical versions of study NCT00226096 on Archive Site
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 [ Time Frame: 24 and 72 hours, 1 and 3 months ]
All cause and cause-specific easrly neurological deterioration during the first 72 hours; haematoma expansion at 24 and 72 hours; cerebral odema; functional disability at 7 days, 1 and 3 months; cognitive function at 1 and 3 months; HRQoL
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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
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.

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.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • CVA (Cerebrovascular Accident)
  • Cerebral Hemorrhage
  • Intracranial Hemorrhages
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2007
September 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Australia,   China,   New Zealand
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The George Institute
National Health and Medical Research Council, Australia
Principal Investigator: Craig Anderson, PhD The George Institute
Principal Investigator: Bruce Neal, PhD The George Institute
The George Institute
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP