Clevidipine to control high blood pressure after acute intracerebral hemorrhage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study compares adults with acute intracerebral hemorrhage who receive IV clevidipine to those treated with alternate IV antihypertensive regimens. Eligible patients present within 12 hours of symptom onset, have a CT-confirmed intraparenchymal hematoma larger than 5 cc, and have systolic blood pressure between 150 and 219 mmHg on repeat measurements. The primary outcome is the proportion of patients who reach and maintain a predefined SBP target with stability within 60 minutes of enrollment. The study is conducted at multiple California sites including UC Irvine, Antelope Valley Medical Center, and Stanford Health Care.

Why it matters

Who can join: the full rules

Inclusion Criteria

1. Age 18 years or older and less than 100 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 1 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 \>5 cc (excluding microhemorrhages)
7. Admission SBP greater than and equal to 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.
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.
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.

Where it's running

• University of California
  Irvine, California, United States Recruiting
• Antelope Valley Medical Center
  Lancaster, California, United States Recruiting
• Stanford Medical Center (Stanford Health Care)
  Palo Alto, California, United States Recruiting
• Cleveland Clinic Martin North Hospital
  Stuart, Florida, United States Recruiting
• University of South Florida
  Tampa, Florida, United States Recruiting
• Cleveland Clinic Florida
  Weston, Florida, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.