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New hope for bleeding stroke: can clevidipine save brains?

NCT ID NCT06402968

Disease control Sponsor: Zeenat Qureshi Stroke Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 07, 2026 · Updated 10 times

Summary

This study tests whether the drug clevidipine can lower blood pressure quickly and steadily in people having a bleeding stroke (intracerebral hemorrhage). High blood pressure can make the bleeding worse, so getting it under control fast is critical. The trial will compare clevidipine to other standard blood pressure treatments in 1,000 adults, measuring how many reach a safe blood pressure target within one hour.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Clevidipine (an intravenous blood pressure medication)
What this could lead to
If successful, this could provide a faster, more reliable way to control blood pressure during a bleeding stroke, potentially reducing brain damage and improving recovery.
What could go wrong
This is a Phase 4 trial, but the benefit over existing treatments is unproven. The drug may cause side effects like low blood pressure or heart rhythm issues, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,018 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hypertensive disorder intracerebral hemorrhage stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypertension Intracerebral hemorrhage Stroke

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    20 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Albany Medical Center

    RECRUITING

    Albany, New York, 12208, United States

  • Antelope Valley Medical Center

    RECRUITING

    Lancaster, California, 93534, United States

  • Augusta University-Neuroscience Center

    RECRUITING

    Augusta, Georgia, 30912, United States

  • CentraCare - St. Cloud Hospital

    RECRUITING

    Saint Cloud, Minnesota, 56303, United States

  • Cleveland Clinic Akron General

    RECRUITING

    Akron, Ohio, 44307, United States

  • Cleveland Clinic Florida

    RECRUITING

    Weston, Florida, 33331, United States

  • Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Cleveland Clinic Martin North Hospital

    RECRUITING

    Stuart, Florida, 34994, United States

  • Community Hospital

    RECRUITING

    Munster, Indiana, 46321, United States

  • Frederick Memorial Hospital

    RECRUITING

    Frederick, Maryland, 21701, United States

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • ProMedica Toledo Hospital

    RECRUITING

    Toledo, Ohio, 43606, United States

  • Stanford Medical Center (Stanford Health Care)

    RECRUITING

    Palo Alto, California, 94304, United States

  • UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • University of California

    RECRUITING

    Irvine, California, 92696-7600, United States

  • University of Michigan Health-West

    RECRUITING

    Wyoming, Michigan, 49519, United States

  • University of Missouri

    RECRUITING

    Columbia, Missouri, 65212, United States

  • University of South Florida

    RECRUITING

    Tampa, Florida, 33606, United States

  • University of Texas Health Science Center San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Wellstar Kennestone Regional Medical Center

    RECRUITING

    Marietta, Georgia, 30060, United States

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