Trial ID or NCT#

NCT01176565

Status

NOT RECRUITING

Purpose

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 > 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.

Official Title

Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH)-II: A Phase III Randomized Multicenter Clinical Trial of Blood Pressure Reduction for Hypertension in Acute Intracerebral Hemorrhage

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Chitra Venkatasubramanian, MBBS, MD, MSc.
Neurocritical care specialist, Stroke and vascular neurologist
Clinical Associate Professor, Neurology & Neurological Sciences Clinical Assistant Professor (By courtesy), Neurosurgery
James Quinn, MD
Emergency medicine doctor, Pediatric emergency medicine doctor
Professor of Emergency Medicine at the Stanford University Medical Center

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CONTACT

Clinical Trials Office
(650) 498-7061