Recruiting
Phase 1
Phase 2

Verapamil

Sponsor:

Global Neurosciences Institute

Code:

NCT03347786

Conditions

Ischemic Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

10 mg Intra-arterial Verapamil

20 mg Intra-arterial Verapamil

Study Details

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

Study ID

NCT03347786

Start date

Apr 20, 2017

Status verified date

Jan, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

Primary outcome measure

  • Number of Participants with Bleeding Complications [ Time Frame: 3 months ]
  • Number of Participants with a Serious Adverse Event of Death [ Time Frame: 3 months ]

Central Contacts and Locations

Locations

AtlantiCare Regional Medical Center

Recruiting

Atlantic City, New Jersey, United States, 08401

Contacts

Rob Szapor, MBA, BSN, RN

609-345-4000rszapor@atlanticare.org

Principal Investigator:

Mandy J Binning, MD

More Information

Sponsor

Global Neurosciences Institute

Last update posted

Jan 17, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Global Neurosciences Institute on 2025-01-17.