NCT03347786 Verapamil for Neuroprotection in Stroke
| NCT ID | NCT03347786 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Global Neurosciences Institute |
| Condition | Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2017-04-20 |
| Primary Completion | 2026-08 |
Trial Parameters
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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.
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
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