Antihypertensive Treatment of Acute Cerebral Hemorrhage-II

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.

Conditions

• Intracerebral Hemorrhage

Interventions

DRUG

Intravenous nicardipine hydrochloride

IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached. If SBP is above the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent may be used (Labetalol 5-20 mg IV bolus every 15 min; diltiazem/urapidil in countries without labetalol) for another hour. Nicardipine infusion is decreased incrementally or is stopped if SBP falls below the desired treatment range. Fluid bolus for SBP still falling below 110 mmHG (millimeters of mercury) with nicardipine off is given to prevent organ hypoperfusion. Vasopressor agents are not used unless symptoms related to or possibly exacerbated by hypoperfusion are present.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• Medical University of South Carolina

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• Neurocritical Care Research Network

  collaborator UNKNOWN

• National Cerebral and Cardiovascular Center, Japan

  collaborator OTHER

• Japan Cardiovascular Research Foundation

  collaborator OTHER

• Beijing Tiantan Hospital

  collaborator OTHER

• China Medical University Hospital

  collaborator OTHER

• University Hospital Heidelberg

  collaborator OTHER

• Seoul National University Hospital

  collaborator OTHER

• University of Minnesota

  lead OTHER

Principal Investigators

• Adnan I Qureshi, MD · University of Minnesota

• Yuko Y Palesch, PhD · Medical University of South Carolina

• Adnan I Qureshi, MD · University of Minnesota

• Yuko Y Palesch, PhD · Medical University of South Carolina

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-05-15

Primary Completion

2015-12-21

Completion

2016-03-08

Countries

• United States
• Canada
• China
• Germany
• Japan
• South Korea
• Taiwan

Study Locations