Using verapamil to protect the brain after a stroke
Intraarterial Verapamil for Neuroprotection in Ischemic Stroke
PHASE1; PHASE2 · Global Neurosciences Institute · NCT03347786
This study is testing if giving verapamil directly into the arteries can help people recover better after having a stroke.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Global Neurosciences Institute (other) |
| Locations | 3 sites (Atlantic City, New Jersey and 2 other locations) |
| Trial ID | NCT03347786 on ClinicalTrials.gov |
What this trial studies
This research investigates the safety and effectiveness of delivering verapamil directly into the arteries of patients who have experienced an acute ischemic stroke. The study focuses on patients who have undergone mechanical thrombectomy, a procedure to remove blood clots. Participants will receive either 10 mg or 20 mg of intra-arterial verapamil to assess its impact on recovery from stroke. The goal is to determine if this approach can improve neurological outcomes following stroke.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who have experienced an acute ischemic stroke and are eligible for mechanical thrombectomy.
Not a fit: Patients with severe strokes, significant pre-existing disabilities, or those with contraindications to verapamil may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance recovery and reduce long-term disability in stroke patients.
How similar studies have performed: While the approach of using intra-arterial verapamil is novel, similar studies have shown promise in exploring neuroprotective strategies for stroke.
Eligibility criteria
Show full inclusion / exclusion 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 ≥4) * 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) * Severe stroke (NIHSS\>22) * Stuporous or comatose * Unlikely to be available for 90 day follow-up
Where this trial is running
Atlantic City, New Jersey and 2 other locations
- AtlantiCare Regional Medical Center — Atlantic City, New Jersey, United States (RECRUITING)
- St Mary Medical Center — Langhorne, Pennsylvania, United States (NOT_YET_RECRUITING)
- Crozer Chester Medical Center — Upland, Pennsylvania, United States (COMPLETED)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ischemic Stroke