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 States1,018 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 range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing clevidipine specifically for blood pressure control during acute intracerebral hemorrhage — how does managing blood pressure in those early hours actually affect what happens to the bleeding in my brain, and is this something my care team is already doing with other medications?
2The trial is listed as Phase NA, which seems unusual — can you explain what that means for how much is already known about clevidipine's safety and effectiveness in this specific situation compared to a standard treatment approach?
3Since the primary outcome being measured is blood pressure monitoring rather than things like disability or survival, does that mean the trial is more focused on whether the drug controls blood pressure reliably, and does that tell us anything yet about whether it leads to better long-term recovery?
4Clevidipine is given intravenously and this is an acute emergency setting — how quickly would a decision need to be made about whether I could participate, and is it even realistic for me or my family to meaningfully consent during a stroke emergency?
5Given that I already have hypertension alongside the intracerebral hemorrhage, are there standard blood pressure treatments that my doctors would use anyway, and what would I be giving up or gaining by participating in this trial instead?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
1. Patients requiring external ventricular drainage consistent with AHA/ASA guidelines or local institutional guidelines are eligible.
. 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).