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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00978822
Recruitment Status : Terminated (Difficult enrollment parameters, subsequently low enrollment. Decision to terminate trial.)
First Posted : September 17, 2009
Results First Posted : February 28, 2023
Last Update Posted : March 2, 2023
Sponsor:
Collaborator:
The Medicines Company
Information provided by (Responsible Party):
Panayiotis Varelas, Henry Ford Health System

Study Description
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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.

Condition or disease Intervention/treatment Phase
Subarachnoid Hemorrhage Hypertension Drug: Clevidipine butyrate injectable emulsion Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clevidipine in Aneurysmal Subarachnoid Hemorrhage, A Pilot Study
Actual Study Start Date : June 2009
Actual Primary Completion Date : November 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: Clevidipine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Clevidipine butyrate injectable emulsion Drug: 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.
Other Name: Cleviprex


Outcome Measures
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Primary Outcome Measures :
  1. Ability to Control and Maintain Blood Pressure Within a Certain Range by the Drug Infusion. [ Time Frame: 30 minutes ]

    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



Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00978822


Locations
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United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
The Medicines Company
Investigators
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Principal Investigator: Panayiotis N Varelas, MD PhD Henry Ford Hospital
More Information
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Responsible Party: Panayiotis Varelas, Principle Investigator, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT00978822    
Other Study ID Numbers: CLV-0904-001
PCF Varelas 5605
First Posted: September 17, 2009    Key Record Dates
Results First Posted: February 28, 2023
Last Update Posted: March 2, 2023
Last Verified: February 2023
Keywords provided by Panayiotis Varelas, Henry Ford Health System:
Subarachnoid hemorrhage
Hypertension
brain Aneurysm
intracerebral hemorrhage
 antihypertensive
calcium channel blockers
infusion
neurocritical care
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Hypertension
Hemorrhage
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Clevidipine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs