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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

Tracking Information
First Submitted Date  ICMJE September 16, 2009
First Posted Date  ICMJE September 17, 2009
Results First Submitted Date  ICMJE January 31, 2023
Results First Posted Date  ICMJE February 28, 2023
Last Update Posted Date March 2, 2023
Actual Study Start Date  ICMJE June 2009
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2023)		 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
Original Primary Outcome Measures  ICMJE
 (submitted: September 16, 2009)		 Ability to control and maintain blood pressure within a certain range by the drug infusion. [ Time Frame: 30 minutes ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Clevidipine to Control Hypertension in Patients Admitted With Aneurysmal Subarachnoid Hemorrhage
Official Title  ICMJE Clevidipine in Aneurysmal Subarachnoid Hemorrhage, A Pilot Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Subarachnoid Hemorrhage
  • Hypertension
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Clevidipine butyrate injectable emulsion
Intervention: Drug: Clevidipine butyrate injectable emulsion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 31, 2023)		 5
Original Estimated Enrollment  ICMJE
 (submitted: September 16, 2009)		 20
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00978822
Other Study ID Numbers  ICMJE CLV-0904-001
PCF Varelas 5605
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Panayiotis Varelas, Henry Ford Health System
Original Responsible Party Panayiotis N. Varelas, MD, PhD, Henry Ford Health System
Current Study Sponsor  ICMJE Henry Ford Health System
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE The Medicines Company
Investigators  ICMJE
Principal Investigator: Panayiotis N Varelas, MD PhD Henry Ford Hospital
PRS Account Henry Ford Health System
Verification Date February 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP