Antihypertensive Treatment in Acute Cerebral Hemorrhage-II

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2011
INTERVENTION: Standard treatment group: The goal for the standard BP reduction group is to reduce and maintain SBP<180 mmHg for 24 hours after randomization, with IV nicardipine. Intensive treatment group: The goal for the intensive BP reduction group is to reduce and maintain SBP <140 mmHg for 24 hours after randomization, with IV nicardipine. CONDITION: Cerebral Hemorrhage PRIMARY OUTCOME: Death or disability, defined by modified Rankin scale (mRS) of 4‐6 at 3 m following treatment. INCLUSION CRITERIA: 1.IV nicardipine can be initiated within 4.5 hours of symptom onset 2.Clinical signs consistent with the diagnosis of stroke, including impairment of language, motor function, cognition, and/or gaze, vision, or neglect 3.Total GCS score(aggregate of verbal, eye, & motor response scores) of 5 or greater at ED arrival 4.CT scan demonstrates intraparenchymal hematoma with manual hematoma volume measurement <60 cc 5.For subjects randomized prior to infusion start: Admission SBP greater than 180 mmHg but less than 240 mmHg AND WITHOUT spontaneous SBP reduction to below 180 mmHg at the time of randomization OR For subjects randomized after infusion start: Admission SBP greater than 180 mmHg but less than 240 mmHg AND WITHOUT SBP reduction to below 140 mmHg at the time of randomization 6.Informed consent obtained by subject, legally authorized representative, or next of kin
Epistemonikos ID: 6c1aa35137f55b71f4fea87c8e6190eb865b2fe5
First added on: Aug 22, 2024