Monday, November 25, 2024
11/25/2024
DESCRIPTION (provided by applicant): Background: It is estimated that 37,000 to 52,400 people in the United States have intracerebral hemorrhage (ICH) every year. ICH is associated with the highest mortality rate of all strokes with only 38% surviving the first year. Hemotoma expansion has been identified as the most common reason for neurological deterioration. Although early evidence suggests that acute hypertension (HTN) may predispose to hematoma expansion, the effect of aggressive treatment of acute HTN is yet to be determined. Objective: A pilot study is proposed to evaluate the treatment feasibility and safety of antihypertensive (anti HTN) treatment (with nicardipine) in subjects with acute HTN associated with ICH. Intervention: The stepwise intervention study (similar in concept to a dose escalation study) will enroll a maximum of 60 subjects with ICH who meet the inclusion criteria. The 3 levels of anti HTN treatment to achieve a prespecified systolic blood pressure range (SBP) will be evaluated for treatment feasibility and safety. The least aggressive SBP goals will be evaluated in the first group of 20 subjects. A specific safety threshold has been defined based on data from previous studies. The Data and Safety Monitoring Board will approve or disapprove advancing to the next anti-HTN treatment goal based on the evaluation of the rate of neurological deterioration and the occurrences of serious adverse events relative to the safety threshold. Outcomes evaluated: The primary outcome evaluated with be the treatment feasibility of the anti HTN treatment, defined as the ability to achieve and maintain treatment goals (the SBP range for the 18-24 hour period). The primary safety outcome will be neurological deterioration defined by a decline in Glasgow Coma Scale by 2 points or greater or increase in National Institute of Health Stroke Scale score by 4 points or greater. Secondary safety outcome will be serious adverse events related to the nicardipine infusion. Other outcomes will include hematoma expansion as determined by serial computed tomographic scans. The 3 month functional outcome measured by modified Rankin Scale and Barthel Index will be used to obtain a preliminary estimate of the treatment effect related to the anti-HTN therapy. Time line: Three years.
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