The Efficacy and Safety of Cleviprex in Ventriculostomy Patients Requiring IV Antihypertensive Therapy
Information source: Methodist Healthcare
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension; Intracranial Hemorrhage; Subarachnoid Hemorrhage
Intervention: Clevidipine butyrate (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Methodist Healthcare Official(s) and/or principal investigator(s):
Christopher K Finch, PharmD, Principal Investigator, Affiliation: Methodist Healthcare, University Hospital
Overall contact:
Christopher K Finch, PharmD, Phone: 901-516-2954, Email: chris.finch@mlh.org
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).
Clinical Details
Official title: The Efficacy and Safety of Cleviprex in Ventriculostomy Patients Requiring IV Antihypertensive Therapy Investigator Initiated Trial
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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: The percentage of patients whose SBP is <90 mmHg within 30 minutes of the initiation of Cleviprex infusion
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Christopher K Finch, PharmD, Phone: 901-516-2954, Email: chris.finch@mlh.org
Methodist Healthcare, University Hospital, Memphis, Tennessee 38104, United States; Recruiting
Rexann Pickering, PhD, RN, Phone: 901-516-2323, Email: rexann.pickering@mlh.org
Lori Kessler, PharmD, Phone: 901-516-8633, Email: lori.kessler@mlh.org
Christopher K Finch, PharmD, Principal Investigator
Additional Information
Related 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.
Starting date: May 2010
Last updated: June 18, 2012
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