The December 2003 report from a National Institute of Neurological Disorders and Stroke (NINDS) Workshop on priorities for clinical research in intracerebral hemorrhage (ICH) recommended clinical trials for evaluation of blood pressure (BP) management in acute ICH as a leading priority. The Special Writing Group of the Stroke Council of the American Heart Association in 1999 and 2007 emphasized the need for clinical trials to ensure evidence-based treatment of acute hypertension in ICH. To address important gaps in current knowledge, we propose to conduct a five-year multi-center, randomized, controlled, Phase III trial with blinded outcome ascertainment to determine the efficacy of early, intensive antihypertensive treatment using intravenous nicardipine for acute hypertension in subjects with spontaneous supratentorial ICH. The primary hypothesis of this large, streamlined, focused trial is that intensive systolic blood pressure (SBP) reduction (SBP <140mmHg -- hereafter referred to as the intensive treatment) using intravenous (IV) nicardipine with treatment initiated within 3 hours of onset of ICH and continued for the next 24 hours reduces the likelihood of death or disability at 3 months after ICH (defined by modified Rankin scale [mRS] score of 4-6) by 10% or greater (absolute difference) compared with standard SBP reduction (SBP <180mmHg -- hereafter referred to as the standard treatment). The underlying mechanism for this expected beneficial effect of intensive treatment is presumably mediated through reduction of the rate and magnitude of hematoma expansion observed in approximately 73% of patients with acute ICH. The trial will recruit a maximum of 1,280 subjects with ICH who meet the eligibility criteria. The proposed clinical trial is a natural extension of numerous case series, a subsequent pilot trial funded by NINDS, and a preliminary randomized controlled trial in this patient population funded by the Australian National Health and Medical Research Council. Both trials recently confirmed the safety and tolerability of both the regimen and goals of antihypertensive treatment in acutely hypertensive patients with ICH, as proposed in the present trial. The Australian trial provided preliminary evidence of attenuation of hematoma expansion with intensive SBP reduction. The proposed trial will have important public health implications by providing necessary information regarding the efficacy and safety of antihypertensive treatment of acute hypertension in subjects with ICH. BP treatment represents a strategy that can be made widely available without the need of specialized equipment and personnel and therefore can make a major impact upon outcome in patients with ICH.
The proposed trial will have important public health implications by providing necessary information regarding the efficacy and safety of treatment of acute hypertension in patients with intracerebral hemorrhage. This type of stroke involves bleeding within the brain leading to damaged brain tissue. It is estimated that 37,000 to 52,400 people in the United States suffer from hemorrhagic stroke per year with only 38% of the patients surviving the first year after the stroke. The high rates of death and disability, and high financial costs connected with this illness demand that new evidenced-based treatments be developed.
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