Intracerebral HemorrhageCLUTCHNCT06402968
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
An observational study of Intracerebral Hemorrhage and Stroke, run by Zeenat Qureshi Stroke Institute at 20 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Intracerebral Hemorrhage, Stroke, Hypertension
- What is being tested?
- Clevidipine Injection and Alternate IV Antihypertensive Regimen
- Type of treatment
- Injection or infusion
- How many people
- 1,018 participants
- Where
- 20 sitesUnited States
- Study dates
- 1 Jun 2024to 30 Jul 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
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- 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.
- 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.
Who cannot join
- Time of symptom onset cannot be reliably assessed.
- Previously known neoplasms, arteriovenous malformation (AVM), or aneurysms.
- Intracerebral hematoma considered to be related to trauma.
- ICH located in infratentorial regions such as pons or midbrain (cerebellar ICH is not an exclusion criteria).
- Subject considered a candidate for immediate surgical intervention by the neurosurgery service.
- Pregnancy, parturition within previous 30 days, or active lactation.
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- 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.
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
United States20 sites, 20 recruiting
- Recruiting
Cleveland Clinic Akron General
Akron, Ohio, 44307
Cierra Goode, 330-344-6000, pashmeen.lakhani@zqsi.org
Catherine Hassett
- Recruiting
Albany Medical Center
Albany, New York, 12208
Wendy Stewart, (518) 262-3125, pashmeen.lakhani@zqsi.org
Panayiotis Varelas
- Recruiting
Augusta University-Neuroscience Center
Augusta, Georgia, 30912
Brandy Quarles, 706-721-0588, pashmeen.lakhani@zqsi.org
Ashutosh Pandey
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Anjan Nagesh Ballekere, 216-444-2200, pashmeen.lakhani@zqsi.org
Gomes Joao
- Recruiting
University of Missouri
Columbia, Missouri, 65212
Ranjini J Nived, (573) 882-2121, pashmeen.lakhani@zqsi.org
Adnan Qureshi
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Moez Bashir, 214-648-3111, pashmeen.lakhani@zqsi.org
DaiWai Olson
- Recruiting
Frederick Memorial Hospital
Frederick, Maryland, 21701
Saad Syed, 240-566-3130, pashmeen.lakhani@zqsi.org
Shahid Rafiq
- Recruiting
University of California
Irvine, California, 92696-7600
Jeein Kim, (949) 824-5011, pashmeen.lakhani@zqsi.org
Sean R. McDougall
- Recruiting
Antelope Valley Medical Center
Lancaster, California, 93534
Melody Halio, 661-949-5000, pashmeen.lakhani@zqsi.org
Hisham Salahuddin
- Recruiting
Wellstar Kennestone Regional Medical Center
Marietta, Georgia, 30060
Shelita Kithcart, (770) 793-5000, pashmeen.lakhani@zqsi.org
Raisa Martinez
- Recruiting
Community Hospital
Munster, Indiana, 46321
Krystle Calvin, 219-836-1600, pashmeen.lakhani@zqsi.org
Aamir Badruddin
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Armand Harb, 212- 241-6696, pashmeen.lakhani@zqsi.org
Fernanda Carvalho-Poyraz
- Recruiting
Stanford Medical Center (Stanford Health Care)
Palo Alto, California, 94304
Stephanie Kemp, (650) 723-4000, pashmeen.lakhani@zqsi.org
Chitra Venkatasubramanian
- Recruiting
CentraCare - St. Cloud Hospital
Saint Cloud, Minnesota, 56303
Jennifer Potter-Vig, 320-251-2700, pashmeen.lakhani@zqsi.org
Fareed Suri
- Recruiting
University of Texas Health Science Center San Antonio
San Antonio, Texas, 78229
Athena Lazaris-Conner, 210-567-7000, pashmeen.lakhani@zqsi.org
Ali Seifi
- Recruiting
Cleveland Clinic Martin North Hospital
Stuart, Florida, 34994
Irene Ball, 772-287-5200, pashmeen.lakhani@zqsi.org
Marc Babi
- Recruiting
University of South Florida
Tampa, Florida, 33606
Marla Hairston, 813-821-8017, pashmeen.lakhani@zqsi.org
David Z. Rose
- Recruiting
ProMedica Toledo Hospital
Toledo, Ohio, 43606
Alessandra Charles, 419-291-4000, pashmeen.lakhani@zqsi.org
Mouhammad Jumaa
- Recruiting
Cleveland Clinic Florida
Weston, Florida, 33331
Laura Duarte, 954-659-5000, pashmeen.lakhani@zqsi.org
Mubashir Pervez
- Recruiting
University of Michigan Health-West
Wyoming, Michigan, 49519
Garrett Hilbelink, 616-252-7200, pashmeen.lakhani@zqsi.org
Fazeel Siddiqui
About this study
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
- Being tested
- Clevidipine Injection, Alternate IV Antihypertensive Regimen
- Medical subject headings
- Cerebral Hemorrhage, Stroke, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clevidipine InjectionDrug
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.
Alternate IV Antihypertensive RegimenDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| designated clevidipine hospitals | Not described Receives: Drug: Clevidipine Injection | |
| designated non-clevidipine hospitals | Not described Receives: Drug: Alternate IV Antihypertensive Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start1 Jun 2024
- Primary completion30 Jan 2028 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,018 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeenat Qureshi Stroke Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Chiesi USA, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402968
- Sponsor's protocol ID
- 45002
- Acronym
- CLUTCH
- Status last verified
- Jan 2026
- First submitted
- 2 May 2024
- Last updated
- 7 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40993486