Verapamil for Neuroprotection in Stroke
Primary Purpose
Ischemic Stroke
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Verapamil
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke
Eligibility Criteria
Inclusion Criteria:
- Written informed consent
- 18 years of age and over
- Acute onset focal neurologic deficit consistent with acute ischemic stroke, or computed tomographic scan consistent with acute cerebral ischemia
- Candidate for mechanical thrombectomy procedure
- Onset of symptoms less than 8 hours
- Measurable neurologic deficit (NIHSS >1)
- Willingness to follow up with rehabilitation therapy
- Anticipated life expectancy of at least 3 months
Exclusion Criteria:
- Pregnancy or suspected pregnancy (pregnancy test will be done on women of child-bearing potential)
- Hepatic and/or renal insufficiency (LFT's>3× upper limit of normal; CrCl < 30ml/min)
- Thrombocytopenia (platelet count <75,000/mm3)
- History of intolerance to verapamil
- Previous functional disability (modified Rankin > 1)
- Stuporous or comatose
- Unlikely to be available for 90 day follow-up
- Severe stroke (NIHSS>22)
Sites / Locations
- Crozer Keystone Health SystemRecruiting
Outcomes
Primary Outcome Measures
Serious Adverse Event
Death
Serious Adverse Event
Hemorrhagic conversion
Secondary Outcome Measures
Full Information
NCT ID
NCT03347786
First Posted
November 9, 2017
Last Updated
August 8, 2022
Sponsor
Global Neurosciences Institute
1. Study Identification
Unique Protocol Identification Number
NCT03347786
Brief Title
Verapamil for Neuroprotection in Stroke
Official Title
Intraarterial Verapamil for Neuroprotection in Ischemic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2017 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Global Neurosciences Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this research study is to test an experimental procedure called intra-arterial delivery of verapamil in patients diagnosed with acute ischemic stroke. This study investigates the safety of intra-arterial delivery of verapamil, a drug used to treat vasospasm (spasm of a blood vessel), and how it affects recovery from stroke. Recruitment is limited to patients that have received mechanical thrombectomy as standard of care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Verapamil
Intervention Description
Intra-arterial delivery of verapamil following mechanical thrombectomy procedure
Primary Outcome Measure Information:
Title
Serious Adverse Event
Description
Death
Time Frame
3 months
Title
Serious Adverse Event
Description
Hemorrhagic conversion
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written informed consent
18 years of age and over
Acute onset focal neurologic deficit consistent with acute ischemic stroke, or computed tomographic scan consistent with acute cerebral ischemia
Candidate for mechanical thrombectomy procedure
Onset of symptoms less than 8 hours
Measurable neurologic deficit (NIHSS >1)
Willingness to follow up with rehabilitation therapy
Anticipated life expectancy of at least 3 months
Exclusion Criteria:
Pregnancy or suspected pregnancy (pregnancy test will be done on women of child-bearing potential)
Hepatic and/or renal insufficiency (LFT's>3× upper limit of normal; CrCl < 30ml/min)
Thrombocytopenia (platelet count <75,000/mm3)
History of intolerance to verapamil
Previous functional disability (modified Rankin > 1)
Stuporous or comatose
Unlikely to be available for 90 day follow-up
Severe stroke (NIHSS>22)
Facility Information:
Facility Name
Crozer Keystone Health System
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mandy Binning
Email
MBinning@gnineuro.org
Phone
844-464-6387
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared as this is a pilot study to determine safety
Learn more about this trial
Verapamil for Neuroprotection in Stroke
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