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
Qualifiers
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 design
Treatments tested in this trial
- Clevidipine Injection
- Alternate IV Antihypertensive Regimen
Treatment groups
1,000 Participants
are divided into 2 treatment groupsLocations
16California
University of California92696-7600, Irvine United States
Antelope Valley Medical Center93534, Lancaster United States
Stanford Medical Center (Stanford Health Care)94304, Palo Alto United States
Florida
Cleveland Clinic Martin North Hospital34994, Stuart United States
Sponsors and collaborators
Zeenat Qureshi Stroke Institute
Lead sponsor
Chiesi USA, Inc.
Collaborator
Source ClinicalTrials.gov