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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Henry Ford Health System.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
The Medicines Company
Information provided by:
Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT00978822
First received: September 16, 2009
Last updated: September 17, 2009
Last verified: September 2009
History of Changes
  Purpose

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 Intervention Phase
Subarachnoid Hemorrhage
Hypertension
 Drug: Clevidipine butyrate injectable emulsion
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clevidipine in Aneurysmal Subarachnoid Hemorrhage, A Pilot Study

Resource links provided by NLM:

Drug Information available for: Clevidipine
U.S. FDA Resources

Further study details as provided by Henry Ford Health System:

Primary Outcome Measures:
  • Ability to control and maintain blood pressure within a certain range by the drug infusion. [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: September 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00978822

Contacts
Contact: Panayiotis N Varelas, MD PhD 313-916-0596 pvarela1@hfhs.org

Locations
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Kathleen Wilson, Bsc, RN     313-916-3501     kwilso10@hfhs.org    
Principal Investigator: Panayiotis N Varelas, MD, PhD            
Sub-Investigator: Tamer Abdelhak, MD            
Sponsors and Collaborators
Henry Ford Health System
The Medicines Company
Investigators
Principal Investigator: Panayiotis N Varelas, MD PhD Henry Ford Hospital
  More Information

No publications provided

Responsible Party: Panayiotis N. Varelas, MD, PhD, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT00978822     History of Changes
Other Study ID Numbers: CLV-0904-001, PCF Varelas 5605
Study First Received: September 16, 2009
Last Updated: September 17, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Henry Ford Health System:
Subarachnoid hemorrhage
Hypertension
brain Aneurysm
intracerebral hemorrhage
 antihypertensive
calcium channel blockers
infusion
neurocritical care

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Intracranial Hemorrhages
Hypertension
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013