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Clevidipine (Cleviprex®) Compared With Urapidil (Ebrantil®) (Clevidipine)

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ClinicalTrials.gov Identifier: NCT03300479
Recruitment Status : Recruiting
First Posted : October 3, 2017
Last Update Posted : October 3, 2017
Sponsor:
Information provided by (Responsible Party):
Emanuela Keller, University of Zurich

Brief Summary:
Intracerebral hemorrhage (ICH) is responsible for 10-15% of primary strokes. ICH is a dynamic process with three phases: initial hemorrhage, followed by hematoma expansion and perihematoma edema formation. Hematoma volume is correlated with disease progression and outcome. Contemporary evidence proposes that elevated blood pressure is associated with hematoma expansion while more than 90% of patients with ICH present with acute hypertension. Uncontrolled blood pressure is a leading cause of ICH and it seems also to be a factor of poorer outcomes. Therefore, rapid reduction and control of blood pressure might ease disease progression and improve the outcome. Clevidipine (Cleviprex®), an ultrashort-acting dihydropyridine calcium channel antagonist, with its rapid onset and short duration might be more effective than conventional antihypertensives to achieve rapid blood pressure control in patients with acute ICH.

Condition or disease Intervention/treatment Phase
Nontraumatic Intracerebral Hemorrhage, Multiple Localized Drug: Clevidipine Drug: Urapidil Phase 4

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, 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 : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: After admission to the ICU the patients presenting with primary intracerebral hemorrhage are evaluated for enrollment. If systolic blood pressure is higher than 160 mmHg, the patient will be randomized in one of the two study groups and intravenous therapy with Cleviprex® or Ebrantil® will start immediately. Data of systemic haemodynamics will be collected continuously by online monitoring, starting at baseline and ending after 24h. 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 Cleviprex® or Ebrantil®, all patients receive Cardene® (standard care in daily clinical routine) for another 24h followed by orally administered antihypertensive medication.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clevidipine (Cleviprex®) Compared With Urapidil (Ebrantil®) for Blood Pressure Reduction in Patients With Primary Intracerebral Hemorrhage: A Randomized Controlled Trial
Actual Study Start Date : June 15, 2017
Estimated Primary Completion Date : June 14, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: Clevidipine

Arm Intervention/treatment
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).
Drug: Clevidipine
Intravenous antihypertensive therapy with Clevidipine for the first 24 hours in patients with nontraumatic intracerebral hemorrhage (ICH).
Other Name: Cleviprex®

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).
Drug: Urapidil
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 Name: Ebrantil®




Primary Outcome Measures :
  1. Achieving the target systolic blood pressure [ Time Frame: 1/2 hours ]
    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®)


Secondary Outcome Measures :
  1. Hypertensive burden - time [ Time Frame: 24 hours ]
    • Hypertensive burden - time out of target range (SBP > 160 mmHg) multiplied with the numeric difference to 160mmHg

  2. Hypotensive burden - time [ Time Frame: 24 hours ]
    • Hypotensive burden - time out of target range (SBP < 120 mmHg) multiplied with the numeric difference to 120mmHg

  3. Cumulative time out [ Time Frame: 24 hours ]
    • Cumulative time out of target systolic blood pressure range (>160 or <120 mmHg)

  4. Hematoma growth [ Time Frame: 6 hours ]
    • Hematoma growth within 6 hours after admission (CCT scan)

  5. Neurological state 1 [ Time Frame: 48 hours ]
    • Glasgow Coma Scale (GCS)

  6. Neurological state 2 [ Time Frame: 48 hours ]
    • modified Ranking Scale (mRS)


Other Outcome Measures:
  1. Costs [ Time Frame: 24 hours ]
    • Cost of study drugs



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients suffering non-traumatic subarachnoid hemorrhage (SAH)
  • Male and female patients between 18 and 90 years
  • Written Signed informed Generalkonsent (GC)consent from a person authorized to represent the patient in the emergency situation
  • German language skills have to be sufficient to understand the nature of this study

Exclusion Criteria:

  • Pre-existing neurological disability
  • Severe concomitant disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03300479


Contacts
Contact: Emanuela Keller, MD Prof +41-44-255-56-71 emanuela.keller@usz.ch
Contact: Oliver Louis Boss, MD +41-44-255-56-24 OliverLouis.Boss@usz.ch

Locations
Switzerland
University Hospital Zurich Recruiting
Zurich, Switzerland, 8091
Contact: Emanuela Keller, MD Prof.    +41 44 255 56 71    emanuela.keller@usz.ch   
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Emanuela Keller, MD Prof University of Zurich

Responsible Party: Emanuela Keller, Prof. Dr. med., University of Zurich
ClinicalTrials.gov Identifier: NCT03300479     History of Changes
Other Study ID Numbers: 2017-00379
First Posted: October 3, 2017    Key Record Dates
Last Update Posted: October 3, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Emanuela Keller, University of Zurich:
nontraumatic intracerebral hemorrhage
Cleviprex®
Ebrantil®
Systolic blood pressure

Additional relevant MeSH terms:
Antihypertensive Agents
Hemorrhage
Cerebral Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Clevidipine
Urapidil
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents