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Study Name/Number: ATACH-II
Title: Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH-II)
Investigator: Chere Gregory, MD
Purpose: The specific aims of this study are to: 1. Definitely determine the therapeutic benefit of intensive SBP treatment (SBP<140 mmHg) compared with standard SBP treatment (SBP<180 mmHg) in reducing the proportion of patients with death and disability (mRS of 4-6) at Day 90 among subjects with ICH treated within 3 hours of symptom onset. 2. Evaluate the therapeutic benefit of the intensive treatment relative to the standard treatment in the subjects' quality of life as measured by EuroQol at 3 months. 3. Evaluate the therapeutic benefit of the intensive treatment relative to the standard treatment in the porportion of hematoma expansion (defined as increase from baseline hematoma volume of >33%) and in the change from baseline peri-hematoma volume at 24 hours on the serial computed tomographic (CT) scans. 4. Assess the safety of the intensive treatment relative to the standard treatment in the proportion of subjects with treatment related serious adverse events (SAEs) within 72 hours.
Eligibility: Age 18 or greater with Intra-cranial hemorrhage that is confirmed by CT with Glaswgow Coma Score of 4 or greater at Emergency Department arrival, Systolic blood pressure of 180 or greater and can be randomized within 4.5 hours of symptom onset
Linkto the current ClinicalTrials.gov record »