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

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

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).

Study Overview

• Status: Withdrawn
• Conditions: Hypertension; Subarachnoid Hemorrhage; Intracranial Hemorrhage
• Intervention / Treatment: Drug: Clevidipine butyrate

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
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Methodist Healthcare, University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	30 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Methodist Healthcare
• Collaborators: The Medicines Company
• Investigators: Principal Investigator: Christopher K Finch, PharmD, Methodist Healthcare, University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Anticipated): December 31, 2010
• Study Completion (Actual): December 31, 2010

Study Registration Dates

• First Submitted: January 4, 2010
• First Submitted That Met QC Criteria: January 4, 2010
• First Posted (Estimate): January 5, 2010

Study Record Updates

• Last Update Posted (Actual): August 14, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: hypertension; intracranial hemorrhage (ICH); subarachnoid hemorrhage (SAH); intracranial monitoring; external ventricular drain (ventriculostomy)
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypertension; Hemorrhage; Intracranial Hemorrhages; Subarachnoid Hemorrhage; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Clevidipine
• Other Study ID Numbers: Cleviprex Use In ICB Patients