Actively Recruiting
Intra-arterial Verapamil for Neuroprotection in Ischemic Stroke
Led by Global Neurosciences Institute · Updated on 2025-01-17
60
Participants Needed
3
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an experimental procedure of delivering verapamil directly into arteries for patients who have had an acute ischemic stroke. This study focuses on testing the safety of intra-arterial verapamil, a drug commonly used to treat blood vessel spasms, and how it affects recovery after stroke. The trial is limited to patients who have already received a mechanical thrombectomy as part of their standard care. Participants are randomly assigned to receive one of two doses of verapamil (10 mg or 20 mg) administered intra-arterially following the mechanical thrombectomy procedure. This randomized, interventional study compares these two treatment groups to explore how the different doses impact patient outcomes and safety. During the study, participants will be monitored for bleeding complications and serious adverse events, including death, over a three-month period. Functional outcomes will be assessed at 30 and 90 days, and neuroimaging will be performed at 180 and 365 days. Researchers will track recovery progress and safety through these evaluations, with an overall follow-up period extending up to one year.
CONDITIONS
Brief Title
Verapamil for Neuroprotection in Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 �34)
- Willingness to follow up with rehabilitation therapy
- Anticipated life expectancy of at least 3 months
You will not qualify if you...
- Pregnancy or suspected pregnancy (pregnancy test will be done on women of child-bearing potential)
- Hepatic and/or renal insufficiency (LFT's >3�d7 upper limit of normal; CrCl < 30ml/min)
- Thrombocytopenia (platelet count <75,000/mm3)
- History of intolerance to verapamil
- Previous functional disability (modified Rankin > 1)
- Severe stroke (NIHSS >22)
- Stuporous or comatose
- Unlikely to be available for 90 day follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment during mechanical thrombectomy procedure
Participants receive intra-arterial verapamil at a randomized dose of 10 mg or 20 mg following a mechanical thrombectomy procedure for ischemic stroke.
1 treatment visit (in-person)
Duration - Up to 3 months
Participants are monitored for safety and functional outcomes after treatment.
Follow-up visits at 30 days and 90 days
Trial Site Locations
Total: 3 locations
1
AtlantiCare Regional Medical Center
Atlantic City, New Jersey, United States, 08401
Actively Recruiting
2
St Mary Medical Center
Langhorne, Pennsylvania, United States, 19047
Not Yet Recruiting
3
Crozer Chester Medical Center
Upland, Pennsylvania, United States, 19013
Completed
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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