Verapamil for Neuroprotection in Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 10 mg Intra-arterial Verapamil, 20 mg Intra-arterial Verapamil.
- Who it may be relevant to
- Registry conditions: Ischemic Stroke. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Intraarterial Verapamil for Neuroprotection in Ischemic Stroke
Overview
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
- Drug 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. - 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.
Primary outcome measures
- Number of Participants with Bleeding Complications [Time frame: 3 months]
- Number of Participants with a Serious Adverse Event of Death [Time frame: 3 months]
Secondary outcome measures (3)
- Functional Outcomes [Time frame: 30-days and 90-days]
- Functional Outcomes [Time frame: 30-days and 90-days]
- Neuroimaging [Time frame: 180 Days, 365 Days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 3 centers
- AtlantiCare Regional Medical Center — Atlantic City
- St Mary Medical Center — Langhorne
- Crozer Chester Medical Center — Upland
Identifiers
NCT: NCT03347786 · GNI_verapamil