Acute Ischemic StrokePhase 1NCT06956521
Intra-Arterial Magnesium Therapy After Mechanical Thrombectomy in Acute Ischemic Stroke
A Phase 1 study testing Magnesium sulfate in people with Acute Ischemic Stroke, run by Baylor College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 95 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Magnesium sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to Jul 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- Patient already enrolled in another experimental treatment trial. Exclusion criteria 1-3 are all contraindications to magnesium therapy,
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Baylor St. Luke's Medical Center
Houston, Texas, 77030
Research Coordinator, 2032933134, max.s.feygin@gmail.com
About this study
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.
Read the detailed description
Patients meeting inclusion and exclusion criteria will undergo a baseline neurologic assessment and will be enrolled following informed consent. The patient will then be taken to the Interventional Radiology suite where the patient will undergo MT as per the standard of care. Participation in this study will never delay the timely provision of urgent MT to patients.
Additionally, as part of the study procedure, the patient will be assigned to Treatment Group 1,2, 3 or 4 based on the consecutive sampling scheme. The first 6 patients enrolled will be in group 1 and receive the lowest dose of MgSO4 as described below. If the analysis of this group deems this dosage to be safe, the following patients will be enrolled into group 2. The same scheme will be followed until all 4 groups are enrolled.
Patients in all groups will receive IA MgSO4 as follows (investigational):
Patients in each group will receive the specified dose of MgSO4 (listed below) diluted in 0.9% sodium chloride. The infusion of IA MgSO4 will be administered over 1-2 minutes.
Dose Escalation Schedule Group 1 0.25g IA MgSO4 Group 2 0.5g IA MgSO4 Group 3 1g IA MgSO4 Group 4 1.5g IA MgSO4
Given the minimal safety data on IA MgSO4, this dosage regimen was derived from previous IV MgSO4 studies and a singular IA MgSO4 study in a separate population to cautiously investigate the safety and tolerability for IA MgSO4.
Following MT and IA infusion, patients will receive a continuous infusion of IV MgSO4 for 24 hours. The maintenance infusion will contain 16g of MgSO4 diluted in 240 ml of 0.9% normal saline, infused at a rate of 10 ml per hour for 24 hours. Patients will follow the standard of care monitoring for post-MT patients with the addition of monitoring for magnesium toxicity.
All pre and post imaging is standard of care for this procedure, including follow up MRI (or CT if MRI contraindicated).
Following discharge from the hospital, all patients enrolled in the study protocol will be followed up in the clinic at 3 months to evaluate the patient's functional clinical outcome. If for any reason, the patient cannot come back for a follow-up visit, the PI/Co-PI's will contact the patient via phone/email to gather the required data. A minimum of mRS and NIHSS should be gathered for follow-up data.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Magnesium sulfate
- Keywords
- stroke, magnesium sulfate, neuroprotection
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulfateDrug
Also called MA 135 magnesium sulfate heptahydrate
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Magnesium sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic MgSO4 Concentration
Measured: 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
Measured: 48 hours post-MT
Secondary outcomes (6)
Proportion of patients with Modified Rankin Scale (mRS) 0 to 2
mRS is a measure of global disability. Total Scale range is 0-6, with lower values indicating better outcomes. mRS </= 2 is considered functional independence based on modified Rankin score.
Measured: 90 days post-MT
Modified Rankin Scales (mRS)
mRS is a measure of global disability. Total Scale range is 0-6, with lower values indicating better outcomes.
- No symptoms at all
- No significant disability despite symptoms; able to carry out all usual duties and activities
- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
- Moderate disability; requiring some help, but able to walk without assistance
- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
- Severe disability; bedridden, incontinent and requiring constant nursing care and attention
- Dead
Measured: 90 days post-MT
Decrease in National Institutes of Health Stroke Scale (NIHSS)
NIHSS is a measure of neurologic deficit. Total Score range 0-42, with higher scores indicating greater severity. The 11 domains assessed are:
1a-c Level of consciousness 2. Best Gaze 3. Visual 4. Facial Palsy 5a. Motor left arm 5b. Motor right arm 6a. Motor left leg 6b. Motor right leg 7. Limb Ataxia 8. Sensory 9. Best Language 10. Dysarthria 11. Extinction and Inattention
Measured: 48 hours post-MT
Proportion of symptomatic intracranial hemorrhage (sICH)
sICH defined as 4 or more increase in NIHSS caused by hemorrhage
Measured: 48 hours post-MT
Proportion of hemorrhagic transformation
Measured: 48 hours post-MT
All causes of death after treatment
Measured: 48 hours post-MT, 90 days post-MT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start1 Jul 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Tanweer, Baylor College of Medicine
- Investigators
- Omar Tanweer, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956521
- Sponsor's protocol ID
- H-50731
- Status last verified
- Sep 2026
- First submitted
- 2 Dec 2024
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Badhiwala JH, Nassiri F, Alhazzani W, Selim MH, Farrokhyar F, Spears J, Kulkarni AV, Singh S, Alqahtani A, Rochwerg B, Alshahrani M, Murty NK, Alhazzani A, Yarascavitch B, Reddy K, Zaidat OO, Almenawer SA. Endovascular Thrombectomy for Acute Ischemic Stroke: A Meta-analysis. JAMA. 2015 Nov 3;314(17):1832-43. doi: 10.1001/jama.2015.13767.
PubMed 26529161Goyal M, Menon BK, van Zwam WH, Dippel DW, Mitchell PJ, Demchuk AM, Davalos A, Majoie CB, van der Lugt A, de Miquel MA, Donnan GA, Roos YB, Bonafe A, Jahan R, Diener HC, van den Berg LA, Levy EI, Berkhemer OA, Pereira VM, Rempel J, Millan M, Davis SM, Roy D, Thornton J, Roman LS, Ribo M, Beumer D, Stouch B, Brown S, Campbell BC, van Oostenbrugge RJ, Saver JL, Hill MD, Jovin TG; HERMES collaborators. Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. Lancet. 2016 Apr 23;387(10029):1723-31. doi: 10.1016/S0140-6736(16)00163-X. Epub 2016 Feb 18.
PubMed 26898852Kral T, Luhmann HJ, Mittmann T, Heinemann U. Role of NMDA receptors and voltage-activated calcium channels in an in vitro model of cerebral ischemia. Brain Res. 1993 May 28;612(1-2):278-88. doi: 10.1016/0006-8993(93)91673-g.
PubMed 8101132Bennion DM, Jones CH, Dang AN, Isenberg J, Graham JT, Lindblad L, Domenig O, Waters MF, Poglitsch M, Sumners C, Steckelings UM. Protective effects of the angiotensin II AT2 receptor agonist compound 21 in ischemic stroke: a nose-to-brain delivery approach. Clin Sci (Lond). 2018 Mar 15;132(5):581-593. doi: 10.1042/CS20180100. Print 2018 Mar 15.
PubMed 29500223Saver JL, Starkman S, Eckstein M, Stratton SJ, Pratt FD, Hamilton S, Conwit R, Liebeskind DS, Sung G, Kramer I, Moreau G, Goldweber R, Sanossian N; FAST-MAG Investigators and Coordinators. Prehospital use of magnesium sulfate as neuroprotection in acute stroke. N Engl J Med. 2015 Feb 5;372(6):528-36. doi: 10.1056/NEJMoa1408827.
PubMed 25651247Muir KW, Lees KR, Ford I, Davis S; Intravenous Magnesium Efficacy in Stroke (IMAGES) Study Investigators. Magnesium for acute stroke (Intravenous Magnesium Efficacy in Stroke trial): randomised controlled trial. Lancet. 2004 Feb 7;363(9407):439-45. doi: 10.1016/S0140-6736(04)15490-1.
PubMed 14962524Griauzde J, Ravindra VM, Chaudhary N, Gemmete JJ, Pandey AS. Neuroprotection for ischemic stroke in the endovascular era: A brief report on the future of intra-arterial therapy. J Clin Neurosci. 2019 Nov;69:289-291. doi: 10.1016/j.jocn.2019.08.001. Epub 2019 Aug 17.
PubMed 31431407Muir KW. Magnesium for neuroprotection in ischaemic stroke: rationale for use and evidence of effectiveness. CNS Drugs. 2001;15(12):921-30. doi: 10.2165/00023210-200115120-00002.
PubMed 11735612Muir KW. Magnesium in stroke treatment. Postgrad Med J. 2002 Nov;78(925):641-5. doi: 10.1136/pmj.78.925.641.
PubMed 12496316Lee EJ, Lee MY, Chang GL, Chen LH, Hu YL, Chen TY, Wu TS. Delayed treatment with magnesium: reduction of brain infarction and improvement of electrophysiological recovery following transient focal cerebral ischemia in rats. J Neurosurg. 2005 Jun;102(6):1085-93. doi: 10.3171/jns.2005.102.6.1085.
PubMed 16028768Marinov MB, Harbaugh KS, Hoopes PJ, Pikus HJ, Harbaugh RE. Neuroprotective effects of preischemia intraarterial magnesium sulfate in reversible focal cerebral ischemia. J Neurosurg. 1996 Jul;85(1):117-24. doi: 10.3171/jns.1996.85.1.0117.
PubMed 8683260Fraser JF, Maniskas M, Trout A, Lukins D, Parker L, Stafford WL, Alhajeri A, Roberts J, Bix GJ. Intra-arterial verapamil post-thrombectomy is feasible, safe, and neuroprotective in stroke. J Cereb Blood Flow Metab. 2017 Nov;37(11):3531-3543. doi: 10.1177/0271678X17705259. Epub 2017 Apr 21.
PubMed 28429604Feng L, Fitzsimmons BF, Young WL, Berman MF, Lin E, Aagaard BD, Duong H, Pile-Spellman J. Intraarterially administered verapamil as adjunct therapy for cerebral vasospasm: safety and 2-year experience. AJNR Am J Neuroradiol. 2002 Sep;23(8):1284-90.
PubMed 12223366Keuskamp J, Murali R, Chao KH. High-dose intraarterial verapamil in the treatment of cerebral vasospasm after aneurysmal subarachnoid hemorrhage. J Neurosurg. 2008 Mar;108(3):458-63. doi: 10.3171/JNS/2008/108/3/0458.
PubMed 18312091Albanese E, Russo A, Quiroga M, Willis RN Jr, Mericle RA, Ulm AJ. Ultrahigh-dose intraarterial infusion of verapamil through an indwelling microcatheter for medically refractory severe vasospasm: initial experience. Clinical article. J Neurosurg. 2010 Oct;113(4):913-22. doi: 10.3171/2009.9.JNS0997.
PubMed 19877802