Actively Recruiting

Age: 18Years - 100Years
All Genders
ID06402968

Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage

Led by Zeenat Qureshi Stroke Institute · Updated on 2026-04-24

1000

Participants Needed

13

Research Sites

26 weeks

Total Duration

On this page

Sponsors

Z

Zeenat Qureshi Stroke Institute

Lead Sponsor

C

Chiesi USA, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the use of intravenous clevidipine compared to other intravenous antihypertensive treatments in patients with intracerebral hemorrhage (ICH) who have high blood pressure. The goal is to see how quickly patients achieve a stable target systolic blood pressure (SBP) within 60 minutes of starting treatment. This research is important to better understand blood pressure management in stroke patients with ICH, supported by the Zeenat Qureshi Stroke Institute. The study compares two groups: one receiving IV clevidipine and the other an alternate IV antihypertensive regimen, mainly IV nicardipine, depending on the hospital. Clevidipine is administered starting at 1-2 mg/hour with dosing adjustments every 90 seconds initially, then every 5-10 minutes as blood pressure approaches the goal. Nicardipine starts at 5 mg/hour and is increased every 5-15 minutes until the target blood pressure is reached. Both treatments follow specific dosing protocols and maximum daily limits. Participants are adults aged 18 to under 100 years who have had recent stroke symptoms and elevated blood pressure. They undergo blood pressure monitoring every 15 minutes. The study involves consent and follow-up visits at 90 and 180 days. Researchers assess blood pressure stability and neurological function using clinical signs and CT scans. Safety and treatment adherence are monitored throughout the study period, which runs from enrollment through follow-up assessments.

CONDITIONS

Brief Title

Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older and less than 100 years
  • New neurological deficits within 12 hours before enrollment
  • Clinical signs consistent with stroke including language, motor, cognitive, gaze, vision, or neglect impairments
  • NIH Stroke Scale score of 1 or greater
  • Glasgow Coma Scale score of 5 or greater at enrollment
  • CT scan showing intraparenchymal hematoma larger than 5 cc
  • Systolic blood pressure between 150 mmHg and less than 220 mmHg on two measurements 5-10 minutes apart
  • Signed informed consent before hospital discharge
  • Patients with anticoagulant-related ICH eligible if reversal treatment is given
  • Eligible if surgical evacuation is planned but not within 6 hours of starting IV antihypertensives
  • Eligible if external ventricular drainage is required
Not Eligible

You will not qualify if you...

  • Unreliable assessment of symptom onset time
  • Known brain tumors, arteriovenous malformations, or aneurysms
  • Intracerebral hematoma caused by trauma
  • ICH located in infratentorial regions such as pons or midbrain (cerebellar ICH allowed)
  • Candidate for immediate neurosurgical intervention
  • Pregnancy, recent childbirth within 30 days, or active breastfeeding
  • History of bleeding disorders except anticoagulant-related ICH
  • Platelet count below 50,000/mm3
  • Known allergy to nicardipine or clevidipine
  • Living will that precludes intensive care treatment
  • Allergy to soy, soy products, eggs, or egg products
  • Disorders of lipid metabolism with hyperlipidemia or related acute conditions
  • Severe aortic stenosis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 72 hours after treatment initiation

Participants have their blood pressure monitored closely following the start of intravenous antihypertensive treatment with clevidipine or an alternate regimen as part of routine care.

Continuous blood pressure monitoring

Trial Site Locations

Total: 13 locations

1

University of California

Irvine, California, United States, 92696-7600

Actively Recruiting

2

Antelope Valley Medical Center

Lancaster, California, United States, 93534

Actively Recruiting

3

Stanford Medical Center (Stanford Health Care)

Palo Alto, California, United States, 94304

Actively Recruiting

4

Cleveland Clinic Martin North Hospital

Stuart, Florida, United States, 34994

Actively Recruiting

5

University of South Florida

Tampa, Florida, United States, 33606

Actively Recruiting

6

Augusta University-Neuroscience Center

Augusta, Georgia, United States, 30912

Actively Recruiting

7

University of Michigan Health-West

Wyoming, Michigan, United States, 49519

Actively Recruiting

8

University of Missouri

Columbia, Missouri, United States, 65212

Actively Recruiting

9

Albany Medical Center

Albany, New York, United States, 12208

Actively Recruiting

10

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Actively Recruiting

11

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

Actively Recruiting

12

UT Southwestern Medical Center

Dallas, Texas, United States, 75390

Actively Recruiting

13

University of Texas Health Science Center San Antonio

San Antonio, Texas, United States, 78229

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

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.

Adnan I Qureshi, William Baskett, Joao A Gomes...

https://pubmed.ncbi.nlm.nih.gov/40993486