- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03300479
Clevidipine (Cleviprex®) Compared With Urapidil (Ebrantil®) (Clevidipine)
Clevidipine (Cleviprex®) Compared With Urapidil (Ebrantil®) for Blood Pressure Reduction in Patients With Primary Intracerebral Hemorrhage: A Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
After admission to the ICU the patients presenting with primary intracerebral hemorrhage (ICH) are evaluated for enrollment. If systolic blood pressure (SBP) is higher than 160 mmHg or SBP <160 mmHg under intravenous antihypertensive drug (e.g. Urapidil), started less than 3 h before randomization, the patient will be randomized in one of the two study groups and intravenous therapy with Clevidipine (Cleviprex®) or Urapidil (Ebrantil®) will start immediately. Data of systemic haemodynamics will be collected continuously by online monitoring, starting at baseline and ending after 24h (study data measurements). In particular, all blood pressure measurements are extracted via an arterial line, which is placed as standard of care in these patients. If the target values are not attained within 30 minutes, the investigators can add or switch to alternative antihypertensive drugs of their choice. 24h after initiation of Clevidipine (Cleviprex®) or Urapidil (Ebrantil®), all patients receive Nicardipine (Cardene®) (standard care in daily clinical routine) for another 24h followed by orally administered antihypertensive medication.
Intracerebral hematoma volume will be determined by readings of noncontrast brain computed tomography (CT) scans using the ABC/2 rule to calculate the volume. As a standard in these patients a CT scan is performed 6 hours after admission to the ICU.
Study Type
Phase
- Phase 4
Contacts and Locations
Study Locations
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Zurich, Switzerland, 8091
- University Hospital Zurich
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Primary intracerebral hemorrhage (ICH)
- Systolic blood pressure (SBP) > 160 mmHg at screening
- Systolic blood pressure (SBP) <160 mmHg under intravenous antihypertensive drug (e.g. Urapidil), started less than 3 h before randomization
- 18 to unlimited years of age
- Signed informed consent obtained
Exclusion Criteria:
- Patients with secondary hemorrhage (bleeding source as aneurysm, arteriovenous malformation or traumatic)
- Patients with concomitant severe critical illness (e.g. sepsis, multi-organ failure)
- Positive pregnancy test for any female of childbearing potential or breast feeding female
- Known allergy to any component of Clevidipine (Cleviprex®), Urapidil Ebrantil®), soya bean oil or severe egg protein allergy
- Contraindications for Clevidipine (Cleviprex®): defect in the lipid metabolism, critical aortic stenosis
- Contraindications for Urapidil (Ebrantil®): aortic coarctation, arterio-venous shunt, breastfeeding period
- Patients with pre-existing disability and legal representative
- Patients participating in a interventional clinical trial within the last 30 days before Start of Treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Clevidipine
The treatment starts at admission to the ICU for 24 hours with 2 mg to a maximum of 16 mg Clevidipine per hour infused intravenously and continuously to reach the systolic target pressure < 160 mmHg (>120 mmHg).
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Intravenous antihypertensive therapy with Clevidipine for the first 24 hours in patients with nontraumatic intracerebral hemorrhage (ICH).
Other Names:
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Active Comparator: Urapidil
The treatment starts at admission to the ICU for 24 hours with 5 mg to a maximum of 40 mg Urapidil per hour infused intravenously and continuously to reach the systolic target pressure < 160 mmHg (>120 mmHg).
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We compare the therapy with Urapidil to Clevidipine for the acute phase (24 hours) in patients with ICH.
We would like to show the efficacy and safety of Clevidipine in this special situation.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Achieving the target systolic blood pressure
Time Frame: 1/2 hours
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Number of patients achieving the target systolic blood pressure (SBP) values (160 -120 mmHg) within 30 minutes after initiation of Clevidipine (Cleviprex®) or Urapidil (Ebrantil®)
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1/2 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hypertensive burden - time
Time Frame: 24 hours
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• Hypertensive burden - time out of target range (SBP > 160 mmHg) multiplied with the numeric difference to 160mmHg
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24 hours
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Hypotensive burden - time
Time Frame: 24 hours
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• Hypotensive burden - time out of target range (SBP < 120 mmHg) multiplied with the numeric difference to 120mmHg
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24 hours
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Cumulative time out
Time Frame: 24 hours
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• Cumulative time out of target systolic blood pressure range (>160 or <120 mmHg)
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24 hours
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Blood pressure variability
Time Frame: 48 hours
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• Blood pressure variability (determined as Standard Deviation (SD) of SBP over time)
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48 hours
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Hematoma growth
Time Frame: 6 hours
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• Hematoma growth within 6 hours after admission (CCT scan)
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6 hours
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Neurological state 1
Time Frame: 48 hours
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• Glasgow Coma Scale (GCS)
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48 hours
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Neurological state 2
Time Frame: 48 hours
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• modified Ranking Scale (mRS)
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48 hours
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Costs
Time Frame: 24 hours
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• Cost of study drugs
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24 hours
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Emanuela Keller, MD Prof, University of Zurich
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Intracranial Hemorrhages
- Hemorrhage
- Cerebral Hemorrhage
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Membrane Transport Modulators
- Serotonin Agents
- Serotonin Receptor Agonists
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Adrenergic alpha-1 Receptor Antagonists
- Adrenergic alpha-Antagonists
- Urapidil
- Clevidipine
Other Study ID Numbers
- 2017-00379
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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Rush University Medical CenterAmerican Heart Association; Rush UniversityCompletedHemorrhage; Intracerebral, Nontraumatic | Ischemic Strokes | Diffusion Weighted Imaging LesionsUnited States
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Tongji HospitalUnknown
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University Hospital, Basel, SwitzerlandSwiss Heart FoundationActive, not recruitingIntracerebral Hemorrhage (ICH)Switzerland
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