Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH): Rationale and Design.

This trial is a multicenter open-labeled pilot trial to determine the tolerability and safetyof three escalating levels of antihypertensive treatment goals for acute hypertension in60 subjects with supratentorial intracerebral hemorrhage (ICH). The pilot trial is thenatural development of numerous case series evaluating the effect of antihypertensivetreatment of acute hypertension in subjects with ICH. The proposed trial will haveimportant public health implications by providing necessary information for a definitivephase III study regarding the efficacy of antihypertensive treatment of acute hypertensionin subjects with ICH. The specific aims of the present pilot study are to: (1) Determinethe tolerability of the treatment as assessed by achieving and maintaining three differentsystolic blood pressure goals with intravenous nicardipine infusion for 18 to 24 hourspostictus in subjects with ICH who present within 6 hours of symptom onset; (2) Definethe safety, assessed by the rate of neurological deterioration during treatment and seriousadverse events, of three escalating systolic blood pressure treatment goals usingintravenous nicardipine infusion; and (3) Obtain preliminary estimates of the treatmenteffect using the rate of hematoma expansion (within 24 hours) and modified Rankin scaleand Barthel index at 3 months following symptom onset. [ABSTRACT FROM AUTHOR]