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

Primary Purpose

Hypertension, Intracranial Hemorrhage, Subarachnoid Hemorrhage

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Clevidipine butyrate
Sponsored by
Methodist Healthcare
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring intracranial hemorrhage (ICH), subarachnoid hemorrhage (SAH), intracranial monitoring, external ventricular drain (ventriculostomy), hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Methodist Healthcare, University Hospital

Outcomes

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.

Secondary Outcome Measures

The percentage of patients whose SBP is <90 mmHg within 30 minutes of the initiation of Cleviprex infusion

Full Information

First Posted
January 4, 2010
Last Updated
August 12, 2019
Sponsor
Methodist Healthcare
Collaborators
The Medicines Company
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1. Study Identification

Unique Protocol Identification Number
NCT01042574
Brief Title
The Efficacy and Safety of Cleviprex in Ventriculostomy Patients Requiring IV Antihypertensive Therapy
Official Title
The Efficacy and Safety of Cleviprex in Ventriculostomy Patients Requiring IV Antihypertensive Therapy Investigator Initiated Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to secure funding
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 31, 2010 (Anticipated)
Study Completion Date
December 31, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Methodist Healthcare
Collaborators
The Medicines Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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: Age 18 years or older Patient presentation with ICH or SAH, and that require ICP monitoring via ventriculostomy drain. Baseline systolic blood pressure (immediately prior to initiation of Cleviprex) >160 mmHg measured Requires IV antihypertensive therapy to achieve SBP 110 - 140 mmHg Patients with a life expectancy of > 5 hours. 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: Receipt of an oral antihypertensive within 2 hours prior to initiation of Cleviprex Receipt of IV nicardipine Glasgow coma score (GCS) of <5 and fixed dilated pupils Expectation that the patient will not tolerate or require > 5 hours of concurrent Cleviprex treatment and ICP monitoring Known or suspected aortic dissection Acute myocardial infarction (AMI) on presentation Positive pregnancy test , known pregnancy or nursing mother Intolerance or allergy to calcium channel blockers Allergy to soybean oil or egg lecithin Known liver failure, cirrhosis or pancreatitis Defective lipid metabolism Severe aortic stenosis Prior directives against advanced life support 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Intracranial Hemorrhage, Subarachnoid Hemorrhage
Keywords
intracranial hemorrhage (ICH), subarachnoid hemorrhage (SAH), intracranial monitoring, external ventricular drain (ventriculostomy), hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Clevidipine butyrate
Other Intervention Name(s)
Cleviprex
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
The percentage of patients whose SBP is <90 mmHg within 30 minutes of the initiation of Cleviprex infusion
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years or older Patient presentation with ICH or SAH, and that require ICP monitoring via ventriculostomy drain. Baseline systolic blood pressure (immediately prior to initiation of Cleviprex) >160 mmHg measured Requires IV antihypertensive therapy to achieve SBP 110 to 140 mmHg Patients with a life expectancy of > 5 hours. Written informed consent from the patient or their legal representative before initiation of any study specific procedures Exclusion Criteria: Receipt of an oral antihypertensive within 2 hours prior to initiation of Cleviprex Receipt of IV nicardipine Glasgow coma score (GCS) of <5 and fixed dilated pupils Expectation that the patient will not tolerate or require > 5 hours of concurrent Cleviprex treatment and ICP monitoring Known or suspected aortic dissection Acute myocardial infarction (AMI) on presentation Positive pregnancy test , known pregnancy or nursing mother Intolerance or allergy to calcium channel blockers Allergy to soybean oil or egg lecithin Known liver failure, cirrhosis or pancreatitis Defective lipid metabolism Severe aortic stenosis Prior directives against advanced life support Participation in other clinical research studies involving the evaluation of investigational drugs or devices within 30 days of enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher K Finch, PharmD
Organizational Affiliation
Methodist Healthcare, University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Methodist Healthcare, University Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18534716
Citation
Pollack CV, Varon J, Garrison NA, Ebrahimi R, Dunbar L, Peacock WF 4th. Clevidipine, an intravenous dihydropyridine calcium channel blocker, is safe and effective for the treatment of patients with acute severe hypertension. Ann Emerg Med. 2009 Mar;53(3):329-38. doi: 10.1016/j.annemergmed.2008.04.025. Epub 2008 Jun 5.
Results Reference
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The Efficacy and Safety of Cleviprex in Ventriculostomy Patients Requiring IV Antihypertensive Therapy

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