Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage

Completed

Phase N/A Results

Trial Description

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.

Detailed Description

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.

Conditions

Interventions

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patient will be randomized to intensive BP lowering regimen and followed at 24 hours, 72 hours, 7 days, 1 and 3 months for response to regimen.

Outcomes

Type Measure Time Frame Safety Issue
Primary The primary efficacy endpoint was proportional change ('growth') in hematoma volume at 24 hours.
Secondary Mortality and dependency (according to a 3-5 score on the mRS, at 3 months ),all cause and cause-specific early neurological deterioration during the first 72 hours; hematoma expansion at 24 and 72 hours; cerebral edema; functional disability at 7 days, 1 and 3 months; cognitive function at 1 and 3 months; HRQoL.
Primary Combination death and dependency, according to a 3-6 scores on the modified Rankin Score. 3 months
Secondary 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 24 and 72 hours, 1 and 3 months

Sponsors