Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage

NCT06402968 | Recruiting FDA Drug

• 1 other identifier: 45002
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 14

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.

Conditions

Intracerebral Hemorrhage; Stroke; Hypertension

Outcome Measures

Primary Outcomes (1)

• Blood Pressure Monitoring

  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. SBP target with stability is defined as achieving a SBP of less than 150 mm Hg and greater than 130 mm Hg with two subsequent consecutive recordings at least 15 minutes apart that show SBP of less than 150 mm Hg and greater than 130 mm Hg.

  15 minutes

Study Arms (2)

designated clevidipine hospitals

Drug: Clevidipine Injection

designated non-clevidipine hospitals

Drug: Alternate IV Antihypertensive Regimen

Interventions

Clevidipine Injection DRUG

Sites will be trained and instructed to administer IV clevidipine according to Food and Drug Administration label, which recommends starting at 1-2 mg/hour, and then doubling the dose initially at short (90 second) intervals. As the BP approaches the goal, the increase in doses should be less than doubling and the time between dose adjustments should be lengthened to every 5-10 minutes. The desired therapeutic response for most patients occurs at doses of 4-6 mg/hour. Most patients have been treated with maximum doses of 16 mg/hour or less. There is limited short-term experience with doses up to 32 mg/hour, and because of lipid load restrictions, no more than 1000 mL or an average of 21 mg/hour of Clevidipine infusion is recommended per 24-hour period. There is little experience beyond 72 hours at any dose.

designated clevidipine hospitals

Alternate IV Antihypertensive Regimen DRUG

The alternate IV antihypertensive regimen would be the institutional standard management at designated "non-clevidipine hospitals". It is expected that most of these sites will be using IV nicardipine, which if administered per FDA label is started at 5 mg/hour and increased by 2.5 mg/hour every 5-15 minutes to a maximum dose of 15mg/hour, until desired BP is reached. Once the goal is reached, then the dose may be reduced to 3 mg/hour.

designated non-clevidipine hospitals

Eligibility Criteria

• Age: 18 Years - 100 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All subjects 18 years or older but less than 100 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.

You may qualify if:

• 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)
• 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.
• 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.
• Patients requiring external ventricular drainage consistent with AHA/ASA guidelines or local institutional guidelines are eligible.

You may not qualify if:

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

Sponsors & Collaborators

• Zeenat Qureshi Stroke Institute: lead
• Chiesi USA, Inc.: collaborator

Study Sites (14)

University of California

Irvine, California, 92696-7600, United States

RECRUITING

Antelope Valley Medical Center

Lancaster, California, 93534, United States

RECRUITING

Stanford Medical Center (Stanford Health Care)

Palo Alto, California, 94304, United States

RECRUITING

Cleveland Clinic Martin North Hospital

Stuart, Florida, 34994, United States

RECRUITING

University of South Florida

Tampa, Florida, 33606, United States

RECRUITING

Augusta University-Neuroscience Center

Augusta, Georgia, 30912, United States

RECRUITING

University of Michigan Health-West

Wyoming, Michigan, 49519, United States

RECRUITING

CentraCare - St. Cloud Hospital

Saint Cloud, Minnesota, 56303, United States

RECRUITING

University of Missouri

Columbia, Missouri, 65212, United States

RECRUITING

Albany Medical Center

Albany, New York, 12208, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

University of Texas Health Science Center San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Related Publications (1)

• Qureshi AI, Baskett W, Gomes JA, Lakhani P, Rabinstein AA, Rose DZ, Suarez JI, Steiner T, Shyu CR. The Association between Hourly Systolic Blood Pressure Variability and Outcomes in Patients with Intracerebral Hemorrhage is Time-Dependent: Post-hoc Analysis of the ATACH-2 Trial. Neurocrit Care. 2026 Apr;44(2):647-655. doi: 10.1007/s12028-025-02376-0. Epub 2025 Sep 24.

  PMID: 40993486 DERIVED

MeSH Terms

Conditions

Cerebral Hemorrhage; Stroke; Hypertension

Interventions

clevidipine

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 7, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): January 30, 2028
• Study Completion (Estimated): July 30, 2028
• Last Updated: June 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)