ATACH-II is a five (5) 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 ATACH-II clincial trial is funded by the National Institute of Neurological Disorders and Stroke part of the National Institutes of Health.
The primary hypothesis of this large, streamlined, focused trial is that intensive systolic blood pressure (SBP) reduction using intravenous (IV) nicardipine with treatment initiated within three (3) hours of onset of ICH and continued for the next 24 hours reduces the likelihood of death or disability at three (3) months after ICH by ten percent (10%) or greater compared with standard SBP reduction. 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 seventy-three percent (73%) of patients with acute ICH.
ATACH-II will recruit a maximum of 1,280 subjects with ICH who meet the eligibility criteria. The trial will have important public health implications as it will provide 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.