Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage

Not yet recruitingOBSERVATIONAL
Enrollment

1,000

Participants

Timeline

Start Date

June 1, 2024

Primary Completion Date

May 30, 2026

Study Completion Date

May 30, 2026

Conditions
Intracerebral HemorrhageStrokeHypertension
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."

All Listed Sponsors
lead

Zeenat Qureshi Stroke Institute

OTHER

NCT06402968 - Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage | Biotech Hunter | Biotech Hunter