Results

A total of 60 patients were recruited (aged 62+/-15.1 years; 56.7% were men) with 18, 20, and 22 patients recruited in each of the tiers of blood pressure reduction of increasing intensity. The mean time interval between symptom onset and presentation to the hospital was 1.8+/-1.4 hours and mean time to initiation of study treatment was 4.2+/-1.7 hours. Primary treatment failure was observed in 6 of 60 patients, all in the last tier. A total of 3 secondary treatment failures were observed, all in the third tier. Overall, a total of 9 of 60 patients had primary or secondary treatment failures. The safety stopping rule was not activated in any of the tiers. Seven neurological deteriorations were observed: 1, 2, and 4 in the first, second, and third tier, respectively. These were related to hematoma expansion (n=6) and hydrocephalus (n=1). The three month mortality ranged from 10% to 22% between the tiers. The age, initial GCS score, hematoma volume and intraventricular extension adjusted mortality did not differ between the three tiers. The age, initial GCS score, hematoma volume and intraventricular extension adjusted three month favorable outcome did not differ between the three tiers. In conclusion, aggressive SBP reduction to 110–140 mm Hg in the first 24 hours using intravenous nicardipine was well tolerated with a low risk of hematoma expansion, neurological deterioration and in-hospital mortality. The results favor pharmacological reduction of SBP in patients with acute ICH.