Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage

Conditions

• Hypertension
• Intracerebral Hemorrhage
• Stroke

Eligibility Criteria

Sex

ALL

Age

18 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• Clevidipine Injection — DRUG
  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.
• Alternate IV Antihypertensive Regimen — DRUG
  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.

Study Details

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 Dates

Start date

Jun 1, 2024

Status verified

Jan 2026

Primary completion

Jan 30, 2028

Completion

Jul 30, 2028

Study Design

Enrollment

1,000 participants (estimated)

Arms

• Arm: designated clevidipine hospitals
• Arm: designated non-clevidipine hospitals

Primary Outcome Measure

Blood Pressure Monitoring [ Time Frame: 15 minutes ]

Locations (13)

Find similar trials in Irvine, CA

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