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

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

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, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Justin Fraser, Principal Investigator, University of Kentucky
ClinicalTrials.gov Identifier:	NCT02912663 History of Changes
Other Study ID Numbers:	Verapami & magnisium sulfate
First Posted:	September 23, 2016
Last Update Posted:	October 26, 2017
Last Verified:	June 2017
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