Verapamil for Neuroprotection in Stroke

NCT03347786 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: GNI_verapamil
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Functional Outcomes

  30-days and 90-days

• Functional Outcomes

  30-days and 90-days

• Neuroimaging

  180 Days, 365 Days

Study Arms (2)

Verapamil 10 mg Treatment Group

EXPERIMENTAL

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

Verapamil 20 mg Treatment Group

EXPERIMENTAL

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

Interventions

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.

Verapamil 10 mg Treatment Group

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.

Verapamil 20 mg Treatment Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Global Neurosciences Institute: lead

Study Sites (3)

AtlantiCare Regional Medical Center

Atlantic City, New Jersey, 08401, United States

RECRUITING

St Mary Medical Center

Langhorne, Pennsylvania, 19047, United States

NOT YET RECRUITING

Crozer Chester Medical Center

Upland, Pennsylvania, 19013, United States

COMPLETED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Global Neurosciences Institute

Model Details: Each trial participant is randomly assigned to one of two total intervention groups. The first intervention group will receive a dose of 10mg Verapamil, while the second intervention group will receive a dose of 20mg Verapamil. Both treatment groups will have Verapamil administered intra-arterially following mechanical thrombectomy.

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 20, 2017
• Study Start: April 20, 2017
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)