Verapamil for Neuroprotection in Stroke

Intraarterial Verapamil for Neuroprotection in Ischemic 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.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke
• Intervention / Treatment: Drug: 10 mg Intra-arterial Verapamil; Drug: 20 mg Intra-arterial Verapamil

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Atlantic City, New Jersey, United States, 08401
      • Recruiting
      • AtlantiCare Regional Medical Center
      • Contact: Rob Szapor, MBA, BSN, RN; Phone Number: 609-345-4000; Email: rszapor@atlanticare.org
      • Principal Investigator: Mandy J Binning, MD
      • Principal Investigator: Erol Veznedaroglu, MD
      • Sub-Investigator: Rudy Rahme, MD
      • Sub-Investigator: Kenneth Liebman, MD
      • Sub-Investigator: Zakaria Hakma, MD
  • Pennsylvania
    • Langhorne, Pennsylvania, United States, 19047
      • Not yet recruiting
      • St Mary Medical Center
      • Principal Investigator: Mandy J Binning, MD
      • Principal Investigator: Erol Veznedaroglu, MD
      • Sub-Investigator: Rudy Rahme, MD
      • Sub-Investigator: Kenneth Liebman, MD
      • Sub-Investigator: Zakaria Hakma, MD
      • Contact: Mary Dawson, Research Manager; Phone Number: 215-710-2000; Email: Mary.Dawson@stmaryhealthcare.org
    • Upland, Pennsylvania, United States, 19013
      • Completed
      • Crozer Chester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Verapamil 10 mg Treatment Group; Ischemic stroke patients with large penumbra are offered Verapamil treatment following mechanical thrombectomy. The patient will be randomly assigned an intervention group with the specified dose (10 mg) Verapamil.	Drug: 10 mg Intra-arterial Verapamil; 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.
Experimental: Verapamil 20 mg Treatment Group; Ischemic stroke patients with large penumbra are offered Verapamil treatment following mechanical thrombectomy. The patient will be randomly assigned an intervention group with the specified dose (20 mg) Verapamil.	Drug: 20 mg Intra-arterial Verapamil; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Bleeding Complications	Bleeding Complications including: symptomatic intracerebral hemorrhage (sICH), and Hemorrhagic Transformation (HT)	3 months
Number of Participants with a Serious Adverse Event of Death	Death	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Outcomes	Change in modified Rankin Scale (mRS) Score	30-days and 90-days
Functional Outcomes	Change in National Institutes of Health Stroke Scale (NIHSS) Score	30-days and 90-days
Neuroimaging	MRI/ CT Scan	180 Days, 365 Days

Collaborators and Investigators

• Sponsor: Global Neurosciences Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2017
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 9, 2017
• First Submitted That Met QC Criteria: November 15, 2017
• First Posted (Actual): November 20, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 15, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Ischemic Stroke; Stroke; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Membrane Transport Modulators; Calcium Channel Blockers; Vasodilator Agents; Verapamil
• Other Study ID Numbers: GNI_verapamil

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared as this is a pilot study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No