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

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.

RCT Entities:   Population Interventions Outcomes