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Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage

NCT06402968 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2026-04-24

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Chiesi USA, Inc.

    collaborator INDUSTRY

  • Zeenat Qureshi Stroke Institute

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2028-01-30
Completion
2028-07-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06402968 on ClinicalTrials.gov