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The Efficacy and Safety of Cleviprex in Ventriculostomy Patients Requiring IV Antihypertensive Therapy

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ClinicalTrials.gov Identifier: NCT01042574
Recruitment Status : Withdrawn
First Posted : January 5, 2010
Last Update Posted : March 22, 2018
Sponsor:
Collaborator:
The Medicines Company
Information provided by (Responsible Party):
Christopher Finch, Methodist Healthcare

Brief Summary:
This study is a single-arm, open label protocol evaluating the use of Cleviprex to rapidly control hypertension in patients who present with intracerebral hemorrhage (ICH) or subarachnoid hemorrhage (SAH), and that require ICP monitoring via ventriculostomy (External Ventricular Drain or EVD).

Condition or disease Intervention/treatment Phase
Hypertension Intracranial Hemorrhage Subarachnoid Hemorrhage Drug: Clevidipine butyrate Phase 4

Detailed Description:

Inclusion Criteria:

The study population will be comprised of men and non-pregnant women age 18 years or older presenting with ICH or SAH that require ICP monitoring via ventriculostomy, and that require IV antihypertensive therapy to a) reduce the risk re-bleeding in SAH and b) reduce the risk of hematoma expansion over time due to further bleeding.

This study population will require rapid and sustained tight control of blood pressure between 110 to 140 mmHg.

Subjects may be included in the study if they meet all of the following criteria:

  1. Age 18 years or older
  2. Patient presentation with ICH or SAH, and that require ICP monitoring via ventriculostomy drain.
  3. Baseline systolic blood pressure (immediately prior to initiation of Cleviprex) >160 mmHg measured
  4. Requires IV antihypertensive therapy to achieve SBP 110 - 140 mmHg
  5. Patients with a life expectancy of > 5 hours.
  6. Written informed consent from the patient or their legal representative before initiation of any study specific procedures

Exclusion Criteria:

Subjects will be excluded from the study if any of the following exclusion criteria apply prior to enrollment:

  1. Receipt of an oral antihypertensive within 2 hours prior to initiation of Cleviprex
  2. Receipt of IV nicardipine
  3. Glasgow coma score (GCS) of <5 and fixed dilated pupils
  4. Expectation that the patient will not tolerate or require > 5 hours of concurrent Cleviprex treatment and ICP monitoring
  5. Known or suspected aortic dissection
  6. Acute myocardial infarction (AMI) on presentation
  7. Positive pregnancy test , known pregnancy or nursing mother
  8. Intolerance or allergy to calcium channel blockers
  9. Allergy to soybean oil or egg lecithin
  10. Known liver failure, cirrhosis or pancreatitis
  11. Defective lipid metabolism
  12. Severe aortic stenosis
  13. Prior directives against advanced life support
  14. Participation in other clinical research studies involving the evaluation of investigational drugs or devices within 30 days of enrollment

Patients excluded for any of the above reasons may be re-screened for participation at any time if the exclusion characteristic has changed.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Cleviprex in Ventriculostomy Patients Requiring IV Antihypertensive Therapy Investigator Initiated Trial
Study Start Date : May 2010
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Clevidipine
U.S. FDA Resources


Intervention Details:
    Drug: Clevidipine butyrate
    Cleviprex will be administered according to current package insert instructions, with a starting dose of 2.0mg/hr for 1.5 minutes and thereafter titrated to lower blood pressure to a target goal of 110 mmHG to 140mmHG.
    Other Name: Cleviprex


Primary Outcome Measures :
  1. The primary endpoint of this trial is the time to achieve the pre-specified SBP target range (110-140) within 30 minutes of the initiation of Cleviprex infusion. [ Time Frame: 30 minutes ]

Secondary Outcome Measures :
  1. The percentage of patients whose SBP is <90 mmHg within 30 minutes of the initiation of Cleviprex infusion [ Time Frame: 30 minutes ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 years or older
  2. Patient presentation with ICH or SAH, and that require ICP monitoring via ventriculostomy drain.
  3. Baseline systolic blood pressure (immediately prior to initiation of Cleviprex) >160 mmHg measured
  4. Requires IV antihypertensive therapy to achieve SBP 110 to 140 mmHg
  5. Patients with a life expectancy of > 5 hours.
  6. Written informed consent from the patient or their legal representative before initiation of any study specific procedures

Exclusion Criteria:

  1. Receipt of an oral antihypertensive within 2 hours prior to initiation of Cleviprex
  2. Receipt of IV nicardipine
  3. Glasgow coma score (GCS) of <5 and fixed dilated pupils
  4. Expectation that the patient will not tolerate or require > 5 hours of concurrent Cleviprex treatment and ICP monitoring
  5. Known or suspected aortic dissection
  6. Acute myocardial infarction (AMI) on presentation
  7. Positive pregnancy test , known pregnancy or nursing mother
  8. Intolerance or allergy to calcium channel blockers
  9. Allergy to soybean oil or egg lecithin
  10. Known liver failure, cirrhosis or pancreatitis
  11. Defective lipid metabolism
  12. Severe aortic stenosis
  13. Prior directives against advanced life support
  14. Participation in other clinical research studies involving the evaluation of investigational drugs or devices within 30 days of enrollment

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): NCT01042574


Locations
United States, Tennessee
Methodist Healthcare, University Hospital
Memphis, Tennessee, United States, 38104
Sponsors and Collaborators
Methodist Healthcare
The Medicines Company
Investigators
Principal Investigator: Christopher K Finch, PharmD Methodist Healthcare, University Hospital

Publications:
Responsible Party: Christopher Finch, Assistant Director, Clinical Pharmacy Services, Methodist Healthcare
ClinicalTrials.gov Identifier: NCT01042574     History of Changes
Other Study ID Numbers: Cleviprex Use In ICB Patients
First Posted: January 5, 2010    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018

Keywords provided by Christopher Finch, Methodist Healthcare:
intracranial hemorrhage (ICH)
subarachnoid hemorrhage (SAH)
intracranial monitoring
external ventricular drain (ventriculostomy)
hypertension

Additional relevant MeSH terms:
Hypertension
Hemorrhage
Subarachnoid Hemorrhage
Intracranial Hemorrhages
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Antihypertensive Agents
Clevidipine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action