Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage (NCT06402968) | Clinical Trial Compass
RecruitingNot Applicable
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
United States1,000 participantsStarted 2024-06-01
Plain-language 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.
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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 \>5 cc (excluding microhemorrhages)
Exclusion criteria
✕. 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.
✕0. 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.