Ischemic Stroke
Conditions
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.
Interventions
DRUG10 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.
DRUG20 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.
Sponsors
Global Neurosciences Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Functional Outcomes | 30-days and 90-days | Change in modified Rankin Scale (mRS) Score |
| Neuroimaging | 180 Days, 365 Days | MRI/ CT Scan |
Countries
United States
Outcome results
None listed