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

Completed · Phase 1 · Has a placebo group

Conditions studied: Ischemic Stroke

In brief

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.

Key facts

Study ID

NCT02912663

Run by

Justin Fraser

People needed

10

Starts

2017-10-11

Expected to finish

2020-01-14

Last updated by the study team

2020-06-24

Who can join

Age: 18 and older, up to 101. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Kentucky Medical Center — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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