RecruitingPhase 1Phase 2NCT03347786

Verapamil for Neuroprotection in Stroke

Intraarterial Verapamil for Neuroprotection in Ischemic Stroke

Sponsor

Global Neurosciences Institute

Enrollment

60 participants

Start Date

Apr 20, 2017

Study Type

INTERVENTIONAL

Conditions

Ischemic Stroke

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria8

Written informed consent
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 Criteria8

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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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.