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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Methodist Healthcare.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
The Medicines Company
Information provided by (Responsible Party):
Christopher Finch, Methodist Healthcare
ClinicalTrials.gov Identifier:
NCT01042574
First received: January 4, 2010
Last updated: June 18, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Hypertension
Intracranial Hemorrhage
Subarachnoid Hemorrhage
Drug: Clevidipine butyrate
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Cleviprex in Ventriculostomy Patients Requiring IV Antihypertensive Therapy Investigator Initiated Trial

Resource links provided by NLM:


Further study details as provided by Methodist Healthcare:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The percentage of patients whose SBP is <90 mmHg within 30 minutes of the initiation of Cleviprex infusion [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: May 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01042574

Contacts
Contact: Christopher K Finch, PharmD 901-516-2954 chris.finch@mlh.org
Contact: Morgan Jones, PharmD 901-516-2954 morgan.jones@mlh.org

Locations
United States, Tennessee
Methodist Healthcare, University Hospital Recruiting
Memphis, Tennessee, United States, 38104
Contact: Rexann Pickering, PhD, RN    901-516-2323    rexann.pickering@mlh.org   
Contact: Lori Kessler, PharmD    901-516-8633    lori.kessler@mlh.org   
Principal Investigator: Christopher K Finch, PharmD         
Sponsors and Collaborators
Methodist Healthcare
The Medicines Company
Investigators
Principal Investigator: Christopher K Finch, PharmD Methodist Healthcare, University Hospital
  More Information

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
Study First Received: January 4, 2010
Last Updated: June 18, 2012
Health Authority: United States: University of Tennessee Institutional Review Board
United States: Methodist Healthcare Institutional Review Board

Keywords provided by 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
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014