NCT03347786PHASE1, PHASE2Recruiting
Verapamil for Neuroprotection in Stroke
Global Neurosciences Institute
Start Date
4/20/2017
Completion Date
12/1/2026
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
Age Range: 18 years to 80 years
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
Interventions
DRUG
10 mg Intra-arterial Verapamil
DRUG
20 mg Intra-arterial Verapamil
Conditions
Ischemic Stroke
Locations
AtlantiCare Regional Medical Center
Atlantic City, New Jersey 08401
United States
St Mary Medical Center
Langhorne, Pennsylvania 19047
United States
Crozer Chester Medical Center
Upland, Pennsylvania 19013
United States