drugset
drugset / Trial / NCT01176565

Antihypertensive Treatment of Acute Cerebral Hemorrhage-II

NCT01176565 ↗

Phase 3 Terminated 1000 enrolled University of Minnesota Beijing Tiantan Hospital · collabChina Medical University Hospital · collabJapan Cardiovascular Research Foundation · collabJohns Hopkins University · collabMedical University of South Carolina · collabNational Cerebral and Cardiovascular Center, Japan · collabNational Institute of Neurological Disorders and Stroke (NINDS) · collabNeurocritical Care Research Network · collabSeoul National University Hospital · collabUniversity Hospital Heidelberg · collabUniversity of Michigan · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

The specific aims of this study are to: 1. Definitively determine the therapeutic benefit of the intensive treatment relative to the standard treatment in the proportion of patients with death and disability (mRS 4-6) at 3 months among subjects with ICH who are treated within 4.5 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 proportion of hematoma expansion (defined as increase from baseline hematoma volume of at least 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.

Timeline

Start
2011-05-15
Primary completion
2015-12-21
Completion
2016-03-08

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Nicardipine Small molecule 5 mg Intravenous

Indications

intracerebral hemorrhage