Intracranial Hemorrhages Clinical Trial
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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