Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03347786

Verapamil for Neuroprotection in Stroke

The purpose of this research study is to test an experimental procedure called intra-arterial delivery of verapamil in patients diagnosed with acute ischemic stroke. This study investigates the safety of intra-arterial delivery of verapamil, a drug used to treat vasospasm (spasm of a blood vessel), and how it affects recovery from stroke. Recruitment is limited to patients that have received mechanical thrombectomy as standard of care.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

AtlantiCare Regional Medical Center, Atlantic City, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

10 mg Intra-arterial Verapamil

Drug

Intra-arterial delivery of verapamil following mechanical thrombectomy procedure will be administered at a randomized dose of 10 mg or 20 mg to consenting patients.

20 mg Intra-arterial Verapamil

Drug

Intra-arterial delivery of verapamil following mechanical thrombectomy procedure will be administered at a randomized dose of 10 mg or 20 mg to consenting patients.

Primary outcomes

  1. Number of Participants with Bleeding Complications

    Time frame: 3 months

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

  2. Number of Participants with a Serious Adverse Event of Death

    Time frame: 3 months

    Death

Secondary outcomes

  1. Functional Outcomes

    Time frame: 30-days and 90-days

    Change in modified Rankin Scale (mRS) Score

  2. Functional Outcomes

    Time frame: 30-days and 90-days

    Change in National Institutes of Health Stroke Scale (NIHSS) Score

  3. Neuroimaging

    Time frame: 180 Days, 365 Days

    MRI/ CT Scan

Sponsors and collaborators

Lead sponsor

Global Neurosciences Institute

Other

Registry information

Official study title

Intraarterial Verapamil for Neuroprotection in Ischemic Stroke

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Nov 20, 2017
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.