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Magnesium And Verapamil After Recanalization in Ischemia of the Cerebrum: a Clinical and Translational Study. (MAVARIC)

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ClinicalTrials.gov Identifier: NCT02912663
Recruitment Status : Recruiting
First Posted : September 23, 2016
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Justin Fraser, University of Kentucky

Study Description
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Brief Summary:
This is a phase 1, blinded-outcome, randomized, placebo controlled study to investigate the safety and feasibility of super-selective intra-arterial administration of verapamil and magnesium sulfate immediately following successful endovascular thrombectomy as a potential neuroprotective synergistic therapeutic strategy in emergent large vessel occlusion stroke. This trial represents the first time that magnesium sulfate will be evaluated in human subjects as a superselectively administered neuroprotective agent administered in an acute time frame as an adjunct to intra-arterial thrombectomy. Furthermore, it will represent the first trial to evaluate combinational therapy for acute stroke neuroprotection.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Drug: Verapamil and Magnesium Sulfate Other: Placebo Phase 1

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Magnesium And Verapamil After Recanalization in Ischemia of the Cerebrum (MAVARIC) in the Kentucky Regional Population: a Clinical and Translational Study.
Actual Study Start Date : October 11, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Verapamil and Magnesium Sulfate
10mg of verapamil in 10 cc of normal saline and 1000mg of magnesium sulfate in 20cc of normal saline will be administered over 20 minutes (1cc/minute) through the microcatheter and into the vessel previously obstructed by clot to the treatment group
 Drug: Verapamil and Magnesium Sulfate
Single dose strategy will be used
Placebo Comparator: Placebo
Control group will receive saline only
 Other: Placebo
Single matching dosing strategy will be used
Other Name: 0.9% sodium chloride


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants having no symptomatic intracranial hemorrhage [ Time Frame: within 48 hours after treatment ]
    Defined as a hemorrhage occurring within 48 hours after study inclusion, temporally related to the intervention, and occurring with worsening neurological status as documented in the clinical exam.


Secondary Outcome Measures :
  1. Number of participants who had no systemic side effects from verapamil and magnesium sulfate [ Time Frame: within 90 days ]
    At any point during study treatment


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 101 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed and dated informed consent and HIPAA form. Participants with impaired capacity may be included provided a Legally Authorized Representative as recognized by the the State of Kentucky, signs the informed consent.
  • Willingness to comply with all study procedures and availability for the duration of the study.
  • Male or female, aged 18 years or older
  • Suspected acute ischemic stroke based on clinical and radiographic evidence as determined and documented by the Stroke Neurology team at University of Kentucky.
  • Participants must meet criteria for intra-arterial thrombectomy as determined and documented by Interventional Neuroradiology attending physician at University of Kentucky.
  • Participants must have an acute thromboembolus within an intracranial artery in the anterior circulation (internal carotid, anterior cerebral, middle cerebral), which undergoes mechanical thrombectomy.
  • Participant must have a TICI 2B or better revascularization via thrombectomy.
  • For females of reproductive potential a negative pregnancy test at baseline is required.

Exclusion Criteria:

  • Pregnant/lactating women
  • Therapeutic anticoagulation prior to admission as it is a relative contraindication to thrombectomy
  • Participants who undergo intra-arterial thrombectomy for acute stroke, in whom only TICI 0-2A revascularization is obtained.
  • Known allergic reactions to components of Verapamil or magnesium sulfate.

  • Verapamil should not be given to individuals who have a serious heart condition such as:

    • sick sinus syndrome or AV block
    • severe heart failure;
    • fainting do to slow heartbeats
    • certain heart rhythm disorders of the atrium (excluding atrial fibrillation)
    • active congestive heart failure;
    • low blood pressure;
    • a nerve-muscle disorder such as myasthenia gravis or muscular dystrophy.
  • Magnesium Sulfate should not be given to individuals with heart block or heart damage.
Contacts and Locations
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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): NCT02912663


Contacts
Contact: Mary Faulkner 859-218-5006 mffaul2@uky.edu
Contact: Justin Fraser, MD, PhD 859-323-0616 jfr235@uky.edu

Locations
United States, Kentucky
University of Kentucky Medical Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: Mary Faulkner    859-218-5006    mffaul2@uky.edu   
Contact: Justin Fraser, MD, PhD    8593230616    jfr235@uky.edu   
Principal Investigator: Justin Fraser, MD, PhD         
Sponsors and Collaborators
Justin Fraser
Investigators
Principal Investigator: Justin Fraser, MD, PhD University of Kentucky
More Information
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Responsible Party: Justin Fraser, Principal Investigator, University of Kentucky
ClinicalTrials.gov Identifier: NCT02912663     History of Changes
Other Study ID Numbers: Verapamil & magnisium sulfate
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Ischemia
Pathologic Processes
Magnesium Sulfate
Verapamil
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
 Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents
Vasodilator Agents