Actively Recruiting

Age: 18Years - 100Years
All Genders
NCT06402968

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

217 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

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

Official 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 started within 12 hours before enrollment
  • Clinical signs of stroke affecting language, movement, cognition, gaze, vision, or neglect
  • National Institutes of Health Stroke Scale score of 1 or higher
  • Glasgow Coma Scale score of 5 or higher at enrollment
  • Brain CT scan showing intraparenchymal hematoma with volume over 5 cc
  • Systolic blood pressure between 150 and less than 220 mmHg on two measurements 5 to 10 minutes apart
  • Signed informed consent before hospital discharge and agreement to 90- and 180-day follow-ups
  • Patients with anticoagulant-related ICH if anticoagulant reversal is done per guidelines
  • Patients undergoing surgical evacuation unless surgery occurs within 6 hours of treatment start
  • Patients needing external ventricular drainage as per guidelines
Not Eligible

You will not qualify if you...

  • Unreliable time of symptom onset
  • Known brain tumors, arteriovenous malformations, or aneurysms
  • Intracerebral hematoma caused by trauma
  • ICH located in infratentorial regions like pons or midbrain (cerebellar ICH allowed)
  • Candidates 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 limits aggressive ICU care
  • Allergies to soybeans, soy products, eggs, or egg products
  • Disorders of lipid metabolism such as hyperlipemia, lipoid nephrosis, or acute pancreatitis with hyperlipidemia
  • Severe aortic stenosis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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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Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage | DecenTrialz