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NCT03347786 Clinical Trial

Verapamil for Neuroprotection in Stroke

Ischemic Stroke Clinical Trial

Official title:
Intraarterial Verapamil for Neuroprotection in Ischemic Stroke

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03347786
Other study ID # GNI_verap
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date April 20, 2017
Est. completion date April 2023

Study information
Verified date August 2022
Source Global Neurosciences Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date April 2023
Est. primary completion date April 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 >1) - 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) - Stuporous or comatose - Unlikely to be available for 90 day follow-up - Severe stroke (NIHSS>22)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Verapamil
Intra-arterial delivery of verapamil following mechanical thrombectomy procedure

Locations
Country Name City State
United States Crozer Keystone Health System Upland Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Global Neurosciences Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Serious Adverse Event Death 3 months
Primary Serious Adverse Event Hemorrhagic conversion 3 months
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