ATACH-II - Antihypertensive Treatment of Cerebral Hemorrhage
Registered with ClinicalTrials.gov: NCT01176565
NIH Project Number: 5U01NS062091-05
The NETT investigated a new collaboration with the NINDS funded, ATACH-II trial. ATACH-II was 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 intracerebral hemorrhage (ICH). The ATACH-II clincial trial was 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 was 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 10% or greater compared with standard SBP reduction. The underlying mechanism for this expected beneficial effect of intensive treatment was presumably mediated through reduction of the rate and magnitude of hematoma expansion observed in approximately 73% of patients with acute ICH.
ATACH-II recruited subjects with ICH who met the eligibility criteria. The trial had important public health implications as it was to provide necessary information regarding the efficacy and safety of antihypertensive treatment of acute hypertension in subjects with ICH. BP treatment represents a strategy that could be made widely available without the need of specialized equipment and personnel, and therefore could make a major impact upon outcome in patients with ICH.