What this study is
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.
What's being tested
- 10 mg Intra-arterial Verapamil
Intervention · DRUG
- 20 mg Intra-arterial Verapamil
Intervention · DRUG
Both interventions
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.
Study details
- Official title
- Intraarterial Verapamil for Neuroprotection in Ischemic Stroke
- Sponsor
- Global Neurosciences Institute
- Conditions
- Ischemic Stroke
- Enrolling
- 60 people
- Starts
- 2017-04-20
- Est. completion
- 2026-12
- Design
- Open-label, randomized, parallel groups, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 80 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (3)
2 openContact for every open site
- Mandy J Binning, MD · Principal investigator
- Erol Veznedaroglu, MD · Principal investigator
- Rudy Rahme, MD · Sub-investigator
- Kenneth Liebman, MD · Sub-investigator
- Zakaria Hakma, MD · Sub-investigator
AtlantiCare Regional Medical Center
Atlantic City, New Jersey, United States
- Rob Szapor, MBA, BSN, RN · Contact609-345-4000rszapor@atlanticare.org
RecruitingSt Mary Medical Center
Langhorne, Pennsylvania, United States
- Mary Dawson, Research Manager · Contact215-710-2000Mary.Dawson@stmaryhealthcare.org
Not yet recruitingCrozer Chester Medical Center
Upland, Pennsylvania, United States
Completed
Study team
Sponsor
Global Neurosciences Institute
Study ID GNI_verapamil
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.