NCT01042574

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).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2010

Shorter than P25 for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2010

Completed
Last Updated

August 14, 2019

Status Verified

March 1, 2018

Enrollment Period

8 months

First QC Date

January 4, 2010

Last Update Submit

August 12, 2019

Conditions

HypertensionIntracranial HemorrhageSubarachnoid Hemorrhage

Keywords

intracranial hemorrhage (ICH)subarachnoid hemorrhage (SAH)intracranial monitoringexternal ventricular drain (ventriculostomy)hypertension

Outcome Measures

Primary Outcomes (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.

    30 minutes

Secondary Outcomes (1)

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

    30 minutes

Interventions

Clevidipine butyrateDRUG

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.

Also known as: Cleviprex

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Healthcare, University Hospital

Memphis, Tennessee, 38104, United States

Location

Related Publications (1)

  • 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.

    PMID: 18534716BACKGROUND

MeSH Terms

Conditions

HypertensionIntracranial HemorrhagesSubarachnoid Hemorrhage

Interventions

clevidipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christopher K Finch, PharmD

    Methodist Healthcare, University Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2010

First Posted

January 5, 2010

Study Start

May 1, 2010

Primary Completion

December 31, 2010

Study Completion

December 31, 2010

Last Updated

August 14, 2019

Record last verified: 2018-03

Locations

US(1)