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 :
Completed
First Posted : September 23, 2016
Last Update Posted : June 24, 2020
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Condition or disease | Intervention/treatment | Phase |
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Ischemic Stroke | Drug: Verapamil and Magnesium Sulfate Other: Placebo | Phase 1 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 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 |
Actual Primary Completion Date : | January 14, 2020 |
Actual Study Completion Date : | January 14, 2020 |

Arm | Intervention/treatment |
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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
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Drug: Verapamil and Magnesium Sulfate
Single dose strategy will be used |
Placebo Comparator: Placebo
Control group will receive saline only
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Other: Placebo
Single matching dosing strategy will be used
Other Name: 0.9% sodium chloride |
- 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.
- 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

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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 |
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.
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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.

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
United States, Kentucky | |
University of Kentucky Medical Center | |
Lexington, Kentucky, United States, 40536 |
Principal Investigator: | Justin Fraser, MD, PhD | University of Kentucky |
Responsible Party: | Justin Fraser, Principal Investigator, University of Kentucky |
ClinicalTrials.gov Identifier: | NCT02912663 |
Other Study ID Numbers: |
Verapamil & magnisium sulfate |
First Posted: | September 23, 2016 Key Record Dates |
Last Update Posted: | June 24, 2020 |
Last Verified: | June 2020 |
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 |
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 Calcium-Regulating Hormones and Agents Tocolytic Agents Reproductive Control Agents Vasodilator Agents |