Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage

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”

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.

Intervention(s) in this Clinical Trial

• 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

Primary Measures

• Combination death and dependency, according to a 3-6 scores on the modified Rankin Score.
  • Time Frame: 3 months
    

Secondary Measures

• 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
    

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: The George Institute Other

Overall Clinical Trial Officials and Contacts

Craig Anderson, PhD Principal Investigator The George Institute  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00226096

Study ID Number: NDA1INTERACT

ClinicalTrials.gov Identifier: NCT00226096

Health Authority: United States: Food and Drug Administration

For further information please see The George Institute for International health's website.