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RECRUITING
NCT06402968

Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage

Sponsor: Zeenat Qureshi Stroke Institute

View on ClinicalTrials.gov

Summary

The aim is to compare the rate of hypertensive subjects with ICH who reach SBP target with stability within 60 minutes of enrollment, among patients treated with IV clevidipine with those treated with alternate IV antihypertensive regimen.

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2024-06-01

Completion Date

2028-07-30

Last Updated

2026-04-07

Healthy Volunteers

No

Interventions

DRUG

Clevidipine Injection

Sites will be trained and instructed to administer IV clevidipine according to Food and Drug Administration label, which recommends starting at 1-2 mg/hour, and then doubling the dose initially at short (90 second) intervals. As the BP approaches the goal, the increase in doses should be less than doubling and the time between dose adjustments should be lengthened to every 5-10 minutes. The desired therapeutic response for most patients occurs at doses of 4-6 mg/hour. Most patients have been treated with maximum doses of 16 mg/hour or less. There is limited short-term experience with doses up to 32 mg/hour, and because of lipid load restrictions, no more than 1000 mL or an average of 21 mg/hour of Clevidipine infusion is recommended per 24-hour period. There is little experience beyond 72 hours at any dose.

DRUG

Alternate IV Antihypertensive Regimen

The alternate IV antihypertensive regimen would be the institutional standard management at designated "non-clevidipine hospitals". It is expected that most of these sites will be using IV nicardipine, which if administered per FDA label is started at 5 mg/hour and increased by 2.5 mg/hour every 5-15 minutes to a maximum dose of 15mg/hour, until desired BP is reached. Once the goal is reached, then the dose may be reduced to 3 mg/hour.

Locations (11)

University of California

Irvine, California, United States

Antelope Valley Medical Center

Lancaster, California, United States

Cleveland Clinic Martin North Hospital

Stuart, Florida, United States

University of South Florida

Tampa, Florida, United States

Augusta University-Neuroscience Center

Augusta, Georgia, United States

University of Michigan Health-West

Wyoming, Michigan, United States

University of Missouri

Columbia, Missouri, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

UT Southwestern Medical Center

Dallas, Texas, United States

University of Texas Health Science Center San Antonio

San Antonio, Texas, United States