Expansion of recruitment time window in antihypertensive treatment of acute cerebral hemorrhage (ATACH) II trial

Abstract

The Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH) II trial is an ongoing multi-center, randomized phase III trial to determine the efficacy of early, intensive, antihypertensive treatment using
intravenous (IV) nicardipine initiated within 3 h of onset of intracerebral hemorrhage (ICH). On March
11th, 2012, the National Institutes of Neurological Disorders and Stroke approved recruitment of patients
with ICH within 4.5 h of symptom onset. The expansion of recruitment window was based on the recent
ATACH-I study analysis that suggests reduction of hematoma expansion and death, and disability in those
subjects who were treated within 4.5 h after symptom onset. Another recent single center study further
identified that hematoma expansion, the primary target for systolic blood pressure reduction, appeared to be
equally prevalent in subjects who are presenting between 3 and 4.5 h. The expansion has the potential to
evaluate the efficacy of the treatment intervention in a larger group of patients with ICH.