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

NCT00978822 | Terminated Phase 2 Results DMC

• 2 other identifiers: CLV-0904-001PCF Varelas 5605
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Subarachnoid Hemorrhage; Hypertension

Keywords

Subarachnoid hemorrhage; Hypertension; brain Aneurysm; intracerebral hemorrhage; antihypertensive; calcium channel blockers; infusion; neurocritical care

Outcome Measures

Primary Outcomes (1)

• Ability to Control and Maintain Blood Pressure Within a Certain Range by the Drug Infusion.

  All patients reached the SBP target after initiation of the first infusion within 14.2 ± 6.4 min (n = 5, range 7-22 min) Study closed October 2012

  30 minutes

Study Arms (1)

Clevidipine butyrate injectable emulsion

EXPERIMENTAL

Drug: Clevidipine butyrate injectable emulsion

Interventions

Clevidipine butyrate injectable emulsion 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.

Also known as: Cleviprex

Clevidipine butyrate injectable emulsion

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of SAH
• Presence of unsecured aneurysm
• Patient age between 18 and 80 years
• Hunt and Hess grade \<5 (non-sedated-paralyzed pt)
• Glasgow Coma scale \>4 (non-sedated-paralyzed pt)
• BP above the pre-specified upper limit set by MD
• Patient has not received pressors or inotropes
• Patient has not received IV anti-hypertensives for more than 5 minutes (sodium nitroprusside infusion should be stopped as clevidipine is started
• Patient has given informed consent

You may not qualify if:

• Patient is \<18 or \>80 years of age
• Patient has Traumatic SAH
• Patient has Perimesencephalic SAH
• Hunt and Hess grade 5 (deeply comatose/ brain dead)
• Glasgow Coma scale 3 or 4 (deeply comatose/brain dead)
• Patient on pressors or anti-hypertensives for more than 5 minutes
• SBP \< 90 mm Hg
• Heart rate \>110
• Patient with Left BBB
• Patient with a permanent ventricular pacemaker
• Known allergy to dihydropyridines or clevidipine
• Known allergy to soy products, beans, eggs or egg products22. Patients with defective lipid metabolism or pathologic hyperlipidemia or lipid nephrosis
• Acute pancreatitis, accompanied by hyperlipidemia
• Severe aortic stenosis
• Pregnancy

Sponsors & Collaborators

• Henry Ford Health System: lead
• The Medicines Company: collaborator

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Hypertension; Intracranial Aneurysm; Cerebral Hemorrhage

Interventions

clevidipine

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intracranial Arterial Diseases; Aneurysm

Results Point of Contact

• Title: Panayiotis Varelas
• Organization: Albany Medical Center

varelap@amc.edu

2488739855

Study Officials

• Panayiotis N Varelas, MD PhD

  Henry Ford Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 16, 2009
• First Posted: September 17, 2009
• Study Start: June 1, 2009
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 2, 2023
• Results First Posted: February 28, 2023

Record last verified: 2023-02

Locations

US (1)