Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorZeenat Qureshi Stroke Institute
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older and less than 100 years.
Onset of new neurological deficits within 12 hours at the time of enrollment and IV clevidipine or alternate IV antihypertensive regimen can be initiated within 12 hours of symptom onset.
Clinical signs consistent with the diagnosis of stroke, including impairment of language, motor function, cognition, and/or gaze, vision, or neglect.
Initial National Institutes of Health Stroke Scale (NIHSS) score of 1 or greater.
Disqualifiers
Time of symptom onset cannot be reliably assessed.
Previously known neoplasms, arteriovenous malformation (AVM), or aneurysms.
Intracerebral hematoma considered to be related to trauma.
ICH located in infratentorial regions such as pons or midbrain (cerebellar ICH is not an exclusion criteria).
Trial population
All subjects 18 years or older but less than 100 years old who present to the study sites with clinical symptoms consistent with an ICH demonstrated on brain imaging are to be screened for study eligibility.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Clevidipine Injection
DrugSites 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
DrugThe 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.
Treatment groups
1,018 Participants
are divided into 2 treatment groupsGroup A: designated clevidipine hospitals1 intervention
Group B: designated non-clevidipine hospitals1 intervention
Trial outcomes
Primary outcomes
1
Blood Pressure Monitoring
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. SBP target with stability is defined as achieving a SBP of less than 150 mm Hg and greater than 130 mm Hg with two subsequent consecutive recordings at least 15 minutes apart that show SBP of less than 150 mm Hg and greater than 130 mm Hg.
Time frame
15 minutesSponsors and contacts
Click on the lead sponsor to view all of their trials.
Zeenat Qureshi Stroke Institute
Lead sponsor
Chiesi USA, Inc.
Collaborator
Source ClinicalTrials.gov