Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
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• Age 18 years or older and less than 90 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 4 or greater.

• Total GCS score (aggregate of verbal, eye, and motor response scores) of 5 or greater at enrollment.

• Computed Tomography (CT) scan of the brain demonstrates intraparenchymal hematoma with manual hematoma volume measurement \<60 cc.

• Admission SBP greater than 150 mmHg but less than 220 mmHg on two repeat measurements at least 5 minutes apart, but no more than 10 minutes apart. The reason for exclusion of ICH patients with initial SBP ≥220 mm Hg is based on a post hoc analysis of ATACH-2, which found that patients with initial SBP ≥220 mm Hg (22.8% of the cohort) reported higher rates of neurological deterioration at 24 hours and renal adverse events until day 7 or discharge in patients treated with intensive SBP reduction compared with standard SBP lowering, without any benefit in reducing hematoma expansion at 24 hours or death or severe disability at 90 days.29

• Signed and dated informed consent by subject, legally authorized representative, or surrogate before index hospital discharge for data collection and agreement to participate in 90- and 180-day follow up visits.

• Patients with anticoagulant-related ICH are eligible as long as anticoagulant reversal is concurrently undertaken consistent with AHA/ASA guidelines.

⁃ Patients who will undergo surgical evacuation consistent with AHA/ASA guidelines or local institutional guidelines are eligible unless surgical evacuation is being performed within 6 hours of initiation of IV clevidipine or alternate IV antihypertensive medication regimen. Ultra-early surgery will necessitate use of anesthetic agents which will confound the effect of IV clevidipine or alternate IV antihypertensive medication regimen. Ultra-early surgery/intervention was not used in the minimally invasive catheter evacuation followed by thrombolysis (MISTIE)/ Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage (CLEAR) trials, which required ICH patients to undergo a repeat CT scan after 6 hours to document absence of any hematoma expansion (with ≤5 mL hematoma growth) compared to a previous CT scan prior to any surgical intervention.34,35

⁃ Patients requiring external ventricular drainage consistent with AHA/ASA guidelines or local institutional guidelines are eligible.

Locations
United States
California
Antelope Valley Medical Center
RECRUITING
Lancaster
Florida
Cleveland Clinic Martin North Hospital
RECRUITING
Stuart
Georgia
Augusta University-Neuroscience Center
RECRUITING
Augusta
Michigan
University of Michigan Health-West
RECRUITING
Wyoming
Missouri
University of Missouri
RECRUITING
Columbia
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Ohio
Cleveland Clinic Foundation
RECRUITING
Cleveland
Texas
UT Southwestern Medical Center
RECRUITING
Dallas
University of Texas Health Science Center San Antonio
RECRUITING
San Antonio
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2028-07-30
Participants
Target number of participants: 1000
Treatments
designated clevidipine hospitals
designated non-clevidipine hospitals
Related Therapeutic Areas
Sponsors
Collaborators: Chiesi USA, Inc.
Leads: Zeenat Qureshi Stroke Institute

This content was sourced from clinicaltrials.gov