RecruitingNCT06402968

Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage


Sponsor

Zeenat Qureshi Stroke Institute

Enrollment

1,000 participants

Start Date

Jun 1, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a medication called clevidipine (given through an IV) for rapidly lowering high blood pressure in people who have had a brain bleed (intracerebral hemorrhage). The study compares clevidipine to other standard IV blood pressure medications to see which controls blood pressure better and leads to better recovery. **You may be eligible if...** - You are 18 years or older and had a brain bleed (confirmed by CT scan showing a bleed larger than 5cc) - Your symptoms started within the past 12 hours - Your blood pressure on arrival is between 150 and 219 mmHg (systolic) - You have a measurable neurological deficit (weakness, speech problem, visual problem, etc.) - Your level of consciousness is adequate (GCS score of 5 or higher) **You may NOT be eligible if...** - Your systolic blood pressure is 220 mmHg or higher at arrival - Your neurological symptoms started more than 12 hours ago - Your CT scan does not confirm a brain bleed, or the bleed is very small (under 5cc) - You are unable to consent and do not have a legal representative available Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGClevidipine 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.

DRUGAlternate 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(13)

University of California

Irvine, California, United States

Antelope Valley Medical Center

Lancaster, California, United States

Stanford Medical Center (Stanford Health Care)

Palo Alto, 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

Albany Medical Center

Albany, New York, 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

View Full Details on ClinicalTrials.gov

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NCT06402968


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