RecruitingPhase not listed

Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 100 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares clevidipine with other blood pressure drugs given through a vein (IV). It is for adults with high blood pressure and bleeding inside the brain. Researchers will see which treatment helps more people reach and keep a target blood pressure within 60 minutes.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 to 99.
  • New stroke symptoms started within the past 12 hours, and IV treatment can start within 12 hours of symptom onset.
  • Signs of stroke, such as trouble speaking, moving, thinking, or seeing. A stroke symptom score (NIHSS) must be at least 1, and an alertness and response score (GCS) must be at least 5.
  • A brain CT scan shows a blood collection larger than 5 milliliters inside the brain tissue.
  • The top blood pressure number is at least 150 but below 220 on two readings taken 5 to 10 minutes apart.
  • You or an authorized person signs consent before you leave the hospital and agrees to follow-up visits at 90 and 180 days.
  • Bleeding linked to blood thinners is allowed if treatment to reverse their effects is given at the same time, following care guidelines.
  • Surgery to remove the blood is allowed if it follows care guidelines and is not done within 6 hours after IV blood pressure treatment starts. A drain to remove fluid from the brain is also allowed under care guidelines.

Who can't join

  • The time symptoms started cannot be reliably determined, or the brain bleeding was caused by an injury.
  • Known tumors, tangled abnormal blood vessels (AVMs), or bulging blood vessels (aneurysms).
  • Bleeding in certain lower brain areas, such as the pons or midbrain. Bleeding in the cerebellum does not rule you out.
  • The brain surgery team thinks you need surgery right away, or your living will does not allow intensive ICU treatment.
  • Pregnant, gave birth within the past 30 days, or currently breastfeeding.
  • A history of bleeding or blood-clotting problems, except bleeding linked to blood thinners; or a platelet count below 50,000. Platelets help blood clot.
  • Known sensitivity to nicardipine or clevidipine, or an allergy to soybeans, soy products, eggs, or egg products.
  • Problems processing fats, such as certain high blood-fat levels, a kidney condition called lipoid nephrosis, or sudden pancreas swelling with high blood-fat levels; or severe narrowing of the heart's aortic valve.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (20)

CA

FL

GA

IN

MD

MI

MN

MO

NY

OH

TX