Safety and Efficacy Study of Clevidipine to Control Hypertension in Patients Admitted With Aneurysmal Subarachnoid Hemorrhage

NCT ID: NCT00978822

Last Updated: 2023-03-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2012-12-31

Brief Summary

This study is designed to assess how rapidly and how safely Clevidipine can be used to control high Blood Pressure in patients with subarachnoid hemorrhage which is a type of brain bleed that happens because of a weak balloon like structure in one of the brain vessels. Control of blood pressure is of high value in preventing this balloon that ruptured and bled from rebleeding. The ultimate cure would be to shut down the aneurysm by a surgical procedure. Clevidipine is a drug that can lower blood pressure and it is given through the vein as a continuous infusion. It is a very short acting drug which is important in controlling labile blood pressure condition with rapid changes between up and down. This trial will test for its rapid actions and check for any side effects and possibly any other potential benefit.

Detailed Description

This is a single center, single-arm, non-blinded dose titration efficacy and safety trial evaluating the ability of clevidipine, a vascular-selective L-type calcium channel antagonist, to rapidly control acute hypertension in patients with aneurysmal subarachnoid hemorrhage. At screening a clinical and neurological examination will be carried out. For the purposes of this study, acute hypertension will be defined as a range of SBP to be controlled within immediately prior to initiation of study drug. Approximately 20 patients with acute A SAH will be enrolled. Infusion of study drug will be initiated as soon ass the patient arrives in the ER and diagnosis is made and consent is obtained. All eligible patients will be enrolled to receive clevidipine in an open label manner.

Clevidipine will be infused at an initial rate of 2.0 mg/h for the first 90 seconds. Thereafter, titration to higher infusion rates can be attempted as needed q90 seconds to obtain the target SBP range.

Titration to effect is to proceed by doubling the dose every 90 seconds, up to a maximum of 32.0 mg/h, until the desired effect (SBP within the target range) is attained. Clevidipine infusion may continue for up to a maximum of 48 hours. Blood pressure and ICP recording will be recorded q 5 minutes. Assessment of safety will be performed throughout the treatment period and until 6 hours after termination of study drug.

Conditions

Subarachnoid Hemorrhage; Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Clevidipine butyrate injectable emulsion

Group Type: EXPERIMENTAL

Clevidipine butyrate injectable emulsion

Intervention Type: DRUG

Clevidipine butyrate injectable emulsion infusion starting at 2 mg/hour and titrating up for effect till 32 mg/h for up to 24 hours starting in the emergency department and continued in the critical care units.

Interventions

Clevidipine butyrate injectable emulsion

Clevidipine butyrate injectable emulsion infusion starting at 2 mg/hour and titrating up for effect till 32 mg/h for up to 24 hours starting in the emergency department and continued in the critical care units.

Intervention Type: DRUG

Other Intervention Names

Cleviprex

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of SAH

2. Presence of unsecured aneurysm

3. Patient age between 18 and 80 years

4. Hunt and Hess grade <5 (non-sedated-paralyzed pt)

5. Glasgow Coma scale >4 (non-sedated-paralyzed pt)

6. BP above the pre-specified upper limit set by MD

7. Patient has not received pressors or inotropes

8. Patient has not received IV anti-hypertensives for more than 5 minutes (sodium nitroprusside infusion should be stopped as clevidipine is started

9. Patient has given informed consent

Exclusion Criteria

1. Patient is <18 or >80 years of age

2. Patient has Traumatic SAH

3. Patient has Perimesencephalic SAH

4. Hunt and Hess grade 5 (deeply comatose/ brain dead)

5. Glasgow Coma scale 3 or 4 (deeply comatose/brain dead)

6. Patient on pressors or anti-hypertensives for more than 5 minutes

7. SBP < 90 mm Hg

8. Heart rate >110

9. Patient with Left BBB

10. Patient with a permanent ventricular pacemaker

11. Known allergy to dihydropyridines or clevidipine

12. Known allergy to soy products, beans, eggs or egg products22. Patients with defective lipid metabolism or pathologic hyperlipidemia or lipid nephrosis

13. Acute pancreatitis, accompanied by hyperlipidemia

14. Severe aortic stenosis

15. Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Medicines Company

INDUSTRY

Sponsor Role: collaborator

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Panayiotis Varelas

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Panayiotis N Varelas, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Hospital

Locations

Henry Ford Hospital

Detroit, Michigan, United States

Countries

United States

Other Identifiers

PCF Varelas 5605

Identifier Type: -

Identifier Source: secondary_id

CLV-0904-001

Identifier Type: -

Identifier Source: org_study_id