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 4000 patients.

Condition	Intervention
CVA (Cerebrovascular Accident) Cerebral Hemorrhage Intracranial Hemorrhages	Drug: Labetalol Hydrochloride  Drug: Metoprolol tartrate  Drug: Hydralazine Hydrochloride  Drug: Glyceral Trinitrate  Drug: Phentolamine mesylate  Drug: nicardipine  Drug: Urapadil

Further Study Details: 

Primary Outcomes: Combination death and dependency, according to a 3-5 score on the mRS, at 3 months
Secondary Outcomes: 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
Expected Total Enrollment:  400

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 wondow, 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, particulalry 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

•Aged 18 years or above •Acute stroke due to spontaneous ICH confirmed by clinical history & CT scan •At leats 2 systolic BP measurements of >/=150mmHg and </=200mmHg, 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00226096

Craig Anderson, Professor      +61-2-9993-4590    canderson@thegeorgeinstitute.org
Jill Chisholm      +61-2-8507-2513    jchisholm@thegeorgeinstitute.org

Australia, New South Wales
      Royal Prince Alfred Hospital, Sydney,  New South Wales,  2050,  Australia

Study chairs or principal investigators

Craig Anderson, PhD,  Principal Investigator,  The George Institute   
Bruce Neal, PhD,  Principal Investigator,  The George Institute   

Study ID Numbers:  NDA1INTERACT
Last Updated:  September 23, 2005
Record first received:  September 23, 2005
ClinicalTrials.gov Identifier:  NCT00226096
Health Authority: United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration; New Zealand: Health Research Council
ClinicalTrials.gov processed this record on 2005-09-27