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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01042574
• Other study ID #: Cleviprex Use In ICB Patients
• Status: Withdrawn
• Phase: Phase 4
• Start date: May 2010
• Est. completion date: December 31, 2010

Study information

• Verified date: March 2018
• Source: Methodist Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2010
• Est. primary completion date: December 31, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Hypertension
• Intracranial Hemorrhage
• Intracranial Hemorrhages
• Subarachnoid Hemorrhage

Intervention

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.

Locations

Country	Name	City	State
United States	Methodist Healthcare, University Hospital	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Methodist Healthcare	The Medicines Company

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The percentage of patients whose SBP is <90 mmHg within 30 minutes of the initiation of Cleviprex infusion		30 minutes