Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage
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|ClinicalTrials.gov Identifier: NCT00226096|
Recruitment Status : Completed
First Posted : September 26, 2005
Last Update Posted : June 26, 2008
|Condition or disease||Intervention/treatment||Phase|
|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 Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||404 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||November 2005|
|Actual Primary Completion Date :||September 2007|
|Actual Study Completion Date :||September 2007|
- Combination death and dependency, according to a 3-6 scores on the modified Rankin Score. [ Time Frame: 3 months ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00226096
|Principal Investigator:||Craig Anderson, PhD||The George Institute|
|Principal Investigator:||Bruce Neal, PhD||The George Institute|