Intra-Arterial Magnesium Therapy After Mechanical Thrombectomy for Acute Ischemic Stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, dose-escalation trial to evaluate the safety and tolerability of intra-arterial magnesium sulfate given after mechanical thrombectomy in acute ischemic stroke patients. Participants undergo standard thrombectomy, followed by targeted IA magnesium administration in ascending dose cohorts (0.25 g, 0.5 g, 1 g, 1.5 g) across four groups, with a 24-hour IV magnesium sulfate infusion. The study uses consecutive sampling to determine a safe dose while ensuring no delay to urgent clot removal. Eligible patients have ICA/MCA occlusion, moderate to severe deficits (NIHSS 6-20), and plan MT with satisfactory reperfusion (TICI ≥2a).

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patient with acute cerebral ischemia due to ICA or MCA occlusion
2. Major neurologic deficits: 6≤NIHSS≤20,
3. Premorbid mRS 0 or 1, or 2
4. Patient's clinical attending physician plans MT procedure as part of routine clinical care,
5. undergo MT with a TICI 2a or better recanalization,
6. Signed informed consent.

Exclusion Criteria:

1. Positive pregnancy test;
2. those undergoing MT with a TICI \<2a revascularization;
3. tandem occlusion of the cervical common or internal carotid artery; and
4. subjects on therapeutic anticoagulation, as it is a relative contraindication to MT, and could be a confounding variable predisposing to intracranial hemorrhage including coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia \<80000/mm3;
5. Second or third-degree heart block without a pacemaker in place,
6. Technical inability to navigate micro-catheter to target clot,
7. Patient already enrolled in another experimental treatment trial. Exclusion criteria 1-3 are all contraindications to magnesium therapy,
8. mRS\>2 caused by a history of prior stroke,
9. Severe hepatic dysfunction, severe renal dysfunction (\<30 mL/min), increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
10. Unsuitable for this clinical study assessed by researcher. Subjects will not be excluded if they received IV t-PA as standard of care.
11. patient is on neuromuscular blocking agents including depolarizing (succinylcholine) and nondepolarizing subtypes (rocuronium, vecuronium, etc);
12. patient is taking any form of CNS depressant including barbiturates, narcotics, outside the setting of anesthesia or ICU sedation
13. patients taking digoxin or other cardiac glycoside

Where it's running

• Baylor St. Luke's Medical Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Omar Tanweer, MD — Baylor College of Medicine
• Study coordinator: Omar Tanweer, MD
• Email: omar.tanweer@bcm.edu
• Phone: (713) 798-4696

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.