Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 80Years
All Genders
ID03347786

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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Frequently Asked Questions

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Intra-arterial Delivery of Verapamil for Neuroprotection in Acute Ischemic Stroke Randomized Study After Mechanical Thrombectomy | DecenTrialz