Antihypertensive Treatment of Acute Cerebral Hemorrhage-II
Status:
Terminated
Trial end date:
2016-03-08
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
University of Minnesota University of Minnesota - Clinical and Translational Science Institute
Collaborators:
Beijing Tiantan Hospital China Medical University Hospital Japan Cardiovascular Research Foundation Johns Hopkins University Medical University of South Carolina National Cerebral and Cardiovascular Center National Institute of Neurological Disorders and Stroke (NINDS) Neurocritical Care Research Network Seoul National University Hospital University Hospital Heidelberg University of Michigan