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Verapamil for Neuroprotection in Stroke

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ClinicalTrials.gov Identifier: NCT03347786
Recruitment Status : Recruiting
First Posted : November 20, 2017
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Erol Veznedaroglu, Global Neurosciences Institute

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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Drug: Verapamil Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intraarterial Verapamil for Neuroprotection in Ischemic Stroke
Actual Study Start Date : April 20, 2017
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

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


Primary Outcome Measures :
  1. Serious Adverse Event [ Time Frame: 3 months ]
    Death

  2. Serious Adverse Event [ Time Frame: 3 months ]
    Hemorrhagic conversion



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 >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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03347786


Locations
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United States, New Jersey
Our Lady of Lourdes Medical Center Recruiting
Camden, New Jersey, United States, 08103
Contact: Christina Maxwell    215-762-6915    cmaxwell@gnineuro.org   
United States, Pennsylvania
Hahnemann University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Christina Maxwell    215-762-6915    cmaxwell@gnineuro.org   
Crozer Keystone Health System Recruiting
Upland, Pennsylvania, United States, 19013
Contact: Christina Maxwell    215-762-6915    cmaxwell@gnineuro.org   
Sponsors and Collaborators
Global Neurosciences Institute

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Responsible Party: Erol Veznedaroglu, Director, Global Neurosciences Institute, Global Neurosciences Institute
ClinicalTrials.gov Identifier: NCT03347786     History of Changes
Other Study ID Numbers: GNI_verap
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared as this is a pilot study to determine safety

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Verapamil
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents