Verapamil for Neuroprotection in Stroke

This study is testing an experimental procedure using intra-arterial verapamil in people who have had an acute ischemic stroke. Verapamil is a drug that treats vasospasm (spasm of a blood vessel). Researchers want to see if giving 10 mg or 20 mg of verapamil directly into an artery after a mechanical thrombectomy (a procedure to remove a blood clot) is safe and how it affects stroke recovery. You may be able to join if you are 18 to 80 years old, have had a recent ischemic stroke, and are a candidate for mechanical thrombectomy. The study will look at bleeding complications and serious adverse events, including death, at 3 months to understand the safety of this treatment. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 60 participants. Participants will be randomly assigned to receive either 10 mg or 20 mg of intra-arterial verapamil.
What's involved
Participants will receive intra-arterial verapamil following a mechanical thrombectomy procedure.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 3 months to monitor for bleeding complications and serious adverse events.

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NCT03347786

Verapamil for Neuroprotection in Stroke

Recruiting
PHASE1Ages 18–80InterventionalTreatment
Global Neurosciences Institute
~60 participants
Updated 2025-01-17 on ClinicalTrials.gov
What's tested:10 mg Intra-arterial Verapamil20 mg Intra-arterial Verapamil

At a glance

Recruiting sites
1 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Bleeding Complications
Measured over 3 months
+1 more outcome measured
Ischemic Stroke
3 sites across 2 states
Pennsylvania2
New Jersey1

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Eligibility criteria

Inclusion

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

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
  • Number of Participants with Bleeding Complications3 months

    Bleeding Complications including: symptomatic intracerebral hemorrhage (sICH), and Hemorrhagic Transformation (HT)

  • Number of Participants with a Serious Adverse Event of Death3 months

    Death