Verapamil for Neuroprotection in Stroke

Phase 1

Recruiting

• Conditions: Ischemic Stroke
• Interventions: Drug: 10 mg Intra-arterial Verapamil; Drug: 20 mg Intra-arterial Verapamil

• Registration Number: NCT03347786
• Lead Sponsor: Global Neurosciences Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-20
• Study First Submitted: 2017-11-09
• Study First Submitted QC: 2017-11-15
• Study First Posted: 2017-11-20
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-17
• Primary Completion: 2026-08
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Verapamil 10 mg Treatment Group	10 mg Intra-arterial Verapamil	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.
Verapamil 20 mg Treatment Group	20 mg Intra-arterial Verapamil	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Functional Outcomes	30-days and 90-days	Change in National Institutes of Health Stroke Scale (NIHSS) Score
Neuroimaging	180 Days, 365 Days	MRI/ CT Scan

Trial Locations

Locations (3)

AtlantiCare Regional Medical Center; 🇺🇸 Atlantic City, New Jersey, United States

St Mary Medical Center; 🇺🇸 Langhorne, Pennsylvania, United States

Crozer Chester Medical Center; 🇺🇸 Upland, Pennsylvania, United States