Actively Recruiting
Intra-arterial Delivery of Verapamil for Neuroprotection in Acute Ischemic Stroke Randomized Study After Mechanical Thrombectomy
Led by Global Neurosciences Institute · Updated on 2025-01-17
60
Participants Needed
3
Research Sites
501 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an experimental treatment called intra-arterial delivery of verapamil in patients diagnosed with acute ischemic stroke. This study focuses on testing the safety of verapamil, a drug used to treat blood vessel spasms, and its effects on the recovery process after a stroke. The study is limited to patients who have already received mechanical thrombectomy as their standard care. This trial is conducted in Phase 1 and Phase 2 to better understand the treatment's safety and potential benefits. Participants will receive intra-arterial verapamil after their mechanical thrombectomy procedure. The verapamil will be given at one of two randomized doses: 10 mg or 20 mg. The treatment is delivered directly into the artery to target the affected area. This approach aims to reduce blood vessel spasms and improve neurological outcomes following a stroke. During the study, researchers will monitor participants for bleeding complications and any serious adverse events, including death, over a three-month period. Participants will also be expected to follow up with rehabilitation therapy as part of their recovery. The study includes careful safety monitoring and assessments to understand the effects of the treatment and ensure participant well-being throughout the trial period.
CONDITIONS
Official Title
Verapamil for Neuroprotection in Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent
- Age 18 years and older
- Acute onset focal neurologic deficit consistent with acute ischemic stroke or CT scan showing acute cerebral ischemia
- Candidate for mechanical thrombectomy procedure
- Symptoms started less than 8 hours before treatment
- Measurable neurological deficit with NIH Stroke Scale score of 4 or higher
- Willingness to follow up with rehabilitation therapy
- Expected to live at least 3 months
You will not qualify if you...
- Pregnancy or suspected pregnancy (pregnancy test required for women of child-bearing potential)
- Liver or kidney failure (liver function tests over 3 times the normal limit; creatinine clearance less than 30 ml/min)
- Low platelet count (less than 75,000/mm3)
- History of intolerance to verapamil
- Previous significant disability (modified Rankin score greater than 1)
- Severe stroke (NIH Stroke Scale score over 22)
- Stuporous or comatose state
- Unlikely to be available for 90-day follow-up
AI-Screening
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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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