Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage (CLUTCH)

April 23, 2026 updated by: Zeenat Qureshi Stroke Institute
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92696-7600
        • Recruiting
        • University of California
        • Contact:
        • Principal Investigator:
          • Sean R. McDougall
      • Lancaster, California, United States, 93534
        • Recruiting
        • Antelope Valley Medical Center
        • Contact:
        • Principal Investigator:
          • Hisham Salahuddin
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford Medical Center (Stanford Health Care)
        • Principal Investigator:
          • Chitra Venkatasubramanian
        • Contact:
    • Florida
      • Stuart, Florida, United States, 34994
        • Recruiting
        • Cleveland Clinic Martin North Hospital
        • Principal Investigator:
          • Marc Babi
        • Contact:
      • Tampa, Florida, United States, 33606
        • Recruiting
        • University of South Florida
        • Contact:
        • Principal Investigator:
          • David Z. Rose
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Augusta University-Neuroscience Center
        • Contact:
        • Principal Investigator:
          • Ashutosh Pandey
    • Michigan
      • Wyoming, Michigan, United States, 49519
        • Recruiting
        • University of Michigan Health-West
        • Principal Investigator:
          • Fazeel Siddiqui
        • Contact:
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Recruiting
        • University of Missouri
        • Principal Investigator:
          • Adnan Qureshi
        • Contact:
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Albany Medical Center
        • Contact:
        • Principal Investigator:
          • Panayiotis Varelas
        • Sub-Investigator:
          • Nabeel Herial
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai
        • Principal Investigator:
          • Fernanda Carvalho-Poyraz
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation
        • Contact:
        • Principal Investigator:
          • Gomes Joao
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern Medical Center
        • Contact:
        • Principal Investigator:
          • DaiWai Olson
        • Principal Investigator:
          • Bappaditya Ray
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • University of Texas Health Science Center San Antonio
        • Contact:
        • Principal Investigator:
          • Ali Seifi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
designated clevidipine hospitals
Drug: Clevidipine Injection
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 non-clevidipine hospitals
Drug: Alternate IV Antihypertensive Regimen
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Pressure Monitoring
Time Frame: 15 minutes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zeenat Qureshi Stroke Institute

Collaborators

Chiesi USA, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Estimated)

January 30, 2028

Study Completion (Estimated)

July 30, 2028

Study Registration Dates

First Submitted

May 2, 2024

First Submitted That Met QC Criteria

May 2, 2024

First Posted (Actual)

May 7, 2024

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 45002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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