Verapamil for Neuroprotection in Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-20

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Beta Blockers In Acute Ischemic Stroke

NCT01061190

Stroke

COMPLETED PHASE2/PHASE3

Superselective Administration of VErapamil During Recanalization in Acute Ischemic Stroke

NCT02235558

Ischemic Stroke

COMPLETED PHASE1

A Study to Evaluate the Efficacy and Safety of CP-101,606 in Subjects With an Acute Stroke

NCT00073476

Stroke

TERMINATED PHASE2

Intra-Arterial Neuroprotective Agents and Cold Saline in Ischemic Stroke Intervention

NCT05032781

Stroke, Ischemic

RECRUITING PHASE1

Intravenous Ancrod for the Treatment of Acute Ischemic Stroke Within 6 Hours After Onset of Symptoms

NCT00343174

Brain Infarction Cerebral Ischemia Acute Stroke

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ischemic Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

10 mg Intra-arterial Verapamil

Intervention Type 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

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.

Group Type EXPERIMENTAL

20 mg Intra-arterial Verapamil

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No