Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage

Launched by ZEENAT QURESHI STROKE INSTITUTE · May 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called clevidipine to see if it can help lower high blood pressure in patients who have experienced a type of stroke known as intracerebral hemorrhage (ICH). The main goal is to find out how quickly and effectively clevidipine can help patients reach a specific target blood pressure within 60 minutes of starting treatment, compared to other standard blood pressure medications.

To be eligible for this trial, participants need to be adults aged 18 to 90 who have had new neurological symptoms, like trouble speaking or moving, within the last 12 hours. They must also have a certain level of consciousness and a specific type of brain scan showing a small bleed in the brain. Participants will receive the medication and be monitored closely for their response to treatment. It's important to note that this trial is not yet recruiting participants, so those interested will need to wait until it begins. If you or a loved one think you might qualify, it could be a potential opportunity to contribute to research aimed at improving treatment for stroke patients.

Gender

ALL

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.