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

NCT06956521 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: H-50731
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this Phase I unblinded, dose-escalation trial is to evaluate the safety and tolerability of intra-arterial magnesium sulfate injection after mechanical thrombectomy in patients experiencing acute ischemic stroke. This trial is one of the first trials to look at IA administration of magnesium sulfate into at risk brain tissue in a selective and localized fashion.

Conditions

Acute Ischemic Stroke

Keywords

stroke; magnesium sulfate; neuroprotection

Outcome Measures

Primary Outcomes (2)

• Systemic MgSO4 Concentration

  6 hours post-MT, 24 hours post-MT

• Proportion of severe adverse events

  severe adverse events including femoral artery dissection, local thrombosis, pseudoaneurysm, arteriovenous fistula, neurotoxicity and loss of reflexes due to magnesium, cardiovascular toxicity (arrythmias, severe bradycardia), respiratory depression

  48 hours post-MT

Secondary Outcomes (6)

• Proportion of patients with Modified Rankin Scale (mRS) 0 to 2

  90 days post-MT

• Modified Rankin Scales (mRS)

  90 days post-MT

• Decrease in National Institutes of Health Stroke Scale (NIHSS)

  48 hours post-MT

• Proportion of symptomatic intracranial hemorrhage (sICH)

  48 hours post-MT

• Proportion of hemorrhagic transformation

  48 hours post-MT

Study Arms (4)

0.25g Magnesium Sulfate

EXPERIMENTAL

0.25g of magnesium sulfate (MgSO4) will be diluted in 0.9% sodium chloride for intra-arterial (IA) administration via the guide catheter already in place in the intracranial internal carotid artery (ICA) on the affected side for MT. The infusion will be administered over 1-2 minutes.

Drug: Magnesium sulfate

0.5g Magnesium Sulfate

EXPERIMENTAL

0.5g of magnesium sulfate (MgSO4) will be diluted in 0.9% sodium chloride for intra-arterial (IA) administration via the guide catheter already in place in the intracranial ICA on the affected side for MT. The infusion will be administered over 1-2 minutes.

Drug: Magnesium sulfate

1.0g Magnesium Sulfate

EXPERIMENTAL

1.0g of magnesium sulfate (MgSO4) will be diluted in 0.9% sodium chloride for intra-arterial (IA) administration via the guide catheter already in place in the intracranial ICA on the affected side for MT. The infusion will be administered over 1-2 minutes.

Drug: Magnesium sulfate

1.5g Magnesium Sulfate

EXPERIMENTAL

1.5g of magnesium sulfate (MgSO4) will be diluted in 0.9% sodium chloride for intra-arterial (IA) administration via the guide catheter already in place in the intracranial ICA on the affected side for MT. The infusion will be administered over 1-2 minutes.

Drug: Magnesium sulfate

Interventions

Magnesium sulfate DRUG

Following MT and IA injection of MgSO4, patients will also receive a continuous infusion of 16g MgSO4 diluted in 240 ml of 0.9% normal saline, infusing at a rate of 10 ml per hour for 24 hours.

Also known as: MA 135 magnesium sulfate heptahydrate

0.25g Magnesium Sulfate; 0.5g Magnesium Sulfate; 1.0g Magnesium Sulfate; 1.5g Magnesium Sulfate

Eligibility Criteria

• Age: 21 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Positive pregnancy test;
• those undergoing MT with a TICI \<2a revascularization;
• tandem occlusion of the cervical common or internal carotid artery; and
• 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;
• Second or third-degree heart block without a pacemaker in place,
• Technical inability to navigate micro-catheter to target clot,
• mRS\>2 caused by a history of prior stroke,
• 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;
• Unsuitable for this clinical study assessed by researcher. Subjects will not be excluded if they received IV t-PA as standard of care.
• patient is on neuromuscular blocking agents including depolarizing (succinylcholine) and nondepolarizing subtypes (rocuronium, vecuronium, etc);
• patient is taking any form of CNS depressant including barbiturates, narcotics, outside the setting of anesthesia or ICU sedation
• patients taking digoxin or other cardiac glycoside

Sponsors & Collaborators

• Baylor College of Medicine: lead

Related Publications (20)

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MeSH Terms

Conditions

Ischemic Stroke; Stroke

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Omar Tanweer, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Omar Tanweer, MD

CONTACT

(713) 798-4696; omar.tanweer@bcm.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cerebrovascular and Endovascular Neurosurgery

Model Details: This trial will follow a dose escalation paradigm such that patients are sequentially enrolled into 4 groups. The first patients enrolled will be in the first group that receives the lowest dose. If the IA magnesium dose is safe in this group, the next patients will be enrolled in the 2nd group that receives a higher dose, this continuing until the final group.

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: May 4, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-05