Clinical trial NCT06402968: Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Official title: Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Intracerebral Hemorrhage
Stroke
Hypertension
Lead sponsor: Zeenat Qureshi Stroke Institute
Sponsor class: OTHER
First posted: 2024-05-07
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All subjects 18 years or older but less than 90 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.

Brief 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 criteria: Inclusion Criteria

1. Age 18 years or older and less than 90 years.
2. 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.
3. Clinical signs consistent with the diagnosis of stroke, including impairment of language, motor function, cognition, and/or gaze, vision, or neglect.
4. Initial National Institutes of Health Stroke Scale (NIHSS) score of 4 or greater.
5. Total GCS score (aggregate of verbal, eye, and motor response scores) of 5 or greater at enrollment.
6. Computed Tomography (CT) scan of the brain demonstrates intraparenchymal hematoma with manual hematoma volume measurement \<60 cc.
7. 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
8. 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.
9. Patients with anticoagulant-related ICH are eligible as long as anticoagulant reversal is concurrently undertaken consistent with AHA/ASA guidelines.
10. 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
11. Patients requiring external ventricular drainage consistent with AHA/ASA guidelines or local institutional guidelines are eligible.

Exclusion Criteria

1. Time of symptom onset cannot be reliably assessed.
2. Previously known neoplasms, arteriovenous malformation (AVM), or aneurysms.
3. Intracerebral hematoma considered to be related to trauma.
4. ICH located in infratentorial regions such as pons or midbrain (cerebellar ICH is not an exclusion criteria).
5. Subject considered a candidate for immediate surgical intervention by the neurosurgery service.
6. Pregnancy, parturition within previous 30 days, or active lactation.
7. Any history of bleeding diathesis or coagulopathy except anticoagulant related ICH.
8. Platelet count of less than 50,000/mm3.
9. Known sensitivity to nicardipine or clevidipine.
10. Patient's living will precludes aggressive ICU management.
11. Patients with allergies to soybeans, soy products, eggs, or egg products.
12. Defective lipid metabolism such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis if it is accompanied by hyperlipidemia.
13. Patients with severe aortic stenosis.

Primary outcomes:
measure: Blood Pressure Monitoring
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: