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Compensation: Varies

Number of Visits: 4

Duration: Immediate post-thrombectomy

24 Participants Needed

Neuroprotective Agents for Ischemic Stroke

Overseen ByThomas W Link, MD, MS

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Northwell Health

Must not be taking: Anticoagulants

Disqualifiers: Pregnancy, Heart block, Renal insufficiency, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for individuals who have experienced a severe stroke caused by a blocked blood vessel. The researchers aim to test whether a combination of intra-arterial cold saline (a cooling solution), minocycline (an antibiotic), and magnesium, delivered directly to the brain immediately after a standard procedure called thrombectomy, can protect brain cells and improve recovery. The study focuses on ensuring the safety and practicality of this treatment method. Suitable participants are those diagnosed with an acute stroke due to a major blood vessel blockage, confirmed by medical imaging. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, if you are on therapeutic anticoagulation, you cannot participate in the trial.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that each component of this trial's treatment has undergone safety studies in humans.

Several studies have confirmed the safety of intra-arterial cold saline for stroke patients. This method cools the brain by delivering cold saline directly to the affected area and has proven both practical and safe.

Minocycline, an antibiotic, is recognized for its safety. Studies have demonstrated its safety and potential benefits for stroke patients. Importantly, it does not increase the risk of brain bleeding, a significant concern in stroke treatment.

Magnesium sulfate has been tested for stroke management and has shown favorable safety results. Although limited data exist on its use in the same manner as in this study, its general application in stroke patients has been safe.

This trial is in its early stages, with a primary focus on ensuring participant safety. Safety remains the top priority before drawing any conclusions about effectiveness.¹ ² ³ ⁴ ⁵

Why do researchers think this study treatment might be promising?

Researchers are excited about these treatments for ischemic stroke because they offer a novel approach to neuroprotection. Unlike standard treatments that focus on restoring blood flow, these treatments involve infusing cold saline, minocycline, and magnesium directly into the brain's arteries. This direct, intra-arterial delivery targets brain tissue immediately after a stroke, potentially reducing damage more effectively. The cooling effect from cold saline might protect brain cells, while minocycline and magnesium have anti-inflammatory and neuroprotective properties, which could enhance recovery after a stroke.

What evidence suggests that this treatment might be an effective treatment for ischemic stroke?

Research has shown that delivering cold saline, minocycline, and magnesium directly into the arteries can protect brain cells during a stroke. In this trial, participants will receive an infusion of these neuroprotective substances immediately after thrombectomy. Cold saline reduces brain damage. Minocycline aids recovery in stroke patients. Magnesium might also help, but more research is needed to confirm this. These treatments target different aspects of the injury process during a stroke and may improve recovery when administered soon after a procedure to unblock blood vessels.³ ⁶ ⁷ ⁸ ⁹

Who Is on the Research Team?

Thomas W Link, MD, MS

Principal Investigator

Northwell Health

Are You a Good Fit for This Trial?

This trial is for adults aged 18-90 with acute ischemic stroke due to large vessel occlusion, who are eligible for intra-arterial thrombectomy. Excluded are pregnant or lactating women, those with certain heart conditions, renal insufficiency, severe liver issues, systemic lupus erythematosus, idiopathic intracranial hypertension, prior therapeutic anticoagulation or known allergies to contrast dye or trial drugs.

Inclusion Criteria

Signed and dated informed consent and IRB form by the patient or legally authorized health care proxy

My brain scan shows a complete blockage in a major brain artery.

I am eligible for a clot removal procedure as confirmed by specialists.

See 2 more

Exclusion Criteria

I have been on blood thinners before coming here.

I have had a heart attack or been diagnosed with heart block.

My blood flow restoration is rated TICI 0-2A.

See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Intra-arterial administration of cold saline, minocycline, and magnesium sulfate immediately after thrombectomy

Immediate post-thrombectomy

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including CT or MRI within 24 hours, and neurologic exams at discharge and 90 days

90 days

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

Intra-arterial cold saline, minocycline, and magnesium

Trial Overview The study tests the safety and feasibility of delivering a mix of neuroprotective agents (cold saline, minocycline and magnesium sulfate) directly into the artery immediately after mechanical clot removal in stroke patients. It's an early-phase trial focusing on targeted therapy to damaged brain areas.

How Is the Trial Designed?

1Treatment groups

Experimental Treatment

Group I: Intra-arterial neuroprotective substancesExperimental Treatment1 Intervention

Cold saline, minocycline, and magnesium sulfate to be infused intra-arterially immediately after thrombectomy via the internal carotid artery. A dose escalation design will be used, as described above in "Study Description."

Intra-arterial cold saline, minocycline, and magnesium is already approved in China, United States for the following indications:

Approved in China as Minocycline Hydrochloride for:

Ischemic stroke

Approved in United States as Magnesium Sulfate for:

Pre-eclampsia
Seizures
Arrhythmias

Approved in United States as Minocycline Hydrochloride for:

Acne
Rosacea
Periodontitis

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

Published Research Related to This Trial

Intravenous magnesium sulfate (MgSO4) did not significantly improve functional outcomes or mortality rates 90 days after stroke in a meta-analysis of 4347 patients across seven randomized controlled trials.

However, in a subgroup analysis of ischemic stroke patients, MgSO4 showed a potential benefit in improving global outcomes, but this finding should be interpreted cautiously due to the small number of patients in that subgroup.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous Magnesium Sulfate in Acute Stroke.Avgerinos, KI., Chatzisotiriou, A., Haidich, AB., et al.[2020]

In a study of 2589 patients, intravenous magnesium sulfate administered within 12 hours of stroke onset did not significantly reduce death or disability at 90 days compared to a placebo, with an odds ratio of 0.95.

While magnesium treatment did not show overall efficacy, it suggested potential benefits in non-cortical strokes, indicating that specific stroke types may respond differently to magnesium therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnesium for acute stroke (Intravenous Magnesium Efficacy in Stroke trial): randomised controlled trial.Muir, KW., Lees, KR., Ford, I., et al.[2022]

Minocycline, an antibiotic with neuroprotective properties, has shown promise in reducing brain damage and improving recovery in animal models of stroke, making it a strong candidate for treating acute ischemic stroke due to its ability to cross the blood-brain barrier and its good safety profile.

Early phase clinical trials indicate that minocycline is safe and may be effective in treating acute ischemic stroke, either alone or with other treatments, but further large-scale studies are necessary to confirm its efficacy and determine its role in stroke therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minocycline development for acute ischemic stroke.Fagan, SC., Cronic, LE., Hess, DC.[2021]

Citations

1.clinicaltrials.govclinicaltrials.gov/study/NCT05032781

Intra-Arterial Neuroprotective Agents and Cold Saline in ...This is a phase I trial that aims to demonstrate safety and feasibility of administering cold saline, minocycline, and magnesium sulfate intra-arterially ...

2.pmc.ncbi.nlm.nih.govpmc.ncbi.nlm.nih.gov/articles/PMC7446578/

Intra-arterial neuroprotective therapy as an adjunct to ...Mechanical thrombectomy for acute ischemic stroke due to large vessel occlusion has been shown to significantly improve outcomes.

3.withpower.comwithpower.com/trial/neuroprotective-agents-for-ischemic-stroke-f842d

Neuroprotective Agents for Ischemic StrokeYes, the treatment is promising because cold saline and magnesium can reduce brain injury, and minocycline has shown to improve outcomes in ischemic stroke.

4.sciencedirect.comsciencedirect.com/science/article/pii/S1052305724006311

Magnesium sulfate in the management of acute ischemic ...The study concluded that MgSO4 has a positive effect, but larger trials were needed to confirm results. The FAST-MAG trial utilized a 4 g loading dose of MgSO4 ...

5.aginganddisease.orgaginganddisease.org/EN/10.14336/AD.2020.0325

Intra-arterial Cold Saline Infusion in StrokeAfter 2 hours of cerebral ischemia, a total of 7 ml of isotonic saline at 23 °C or 37 °C was infused through the filament into the ischemic region at 2 ml/min.

6.pmc.ncbi.nlm.nih.govpmc.ncbi.nlm.nih.gov/articles/PMC7673854/

Intra-arterial Cold Saline Infusion in StrokeIntravenous Administration of Standard Dose Tirofiban after Mechanical Arterial Recanalization is Safe and Relatively Effective in Acute Ischemic Stroke.

7.ahajournals.orgahajournals.org/doi/10.1161/STROKEAHA.116.012727

Endovascular Hypothermia in Acute Ischemic StrokeOur results suggest that selective brain cooling by intra-arterial infusion of cold saline is feasible and safe in patients with acute ischemic ...

8.thejns.orgthejns.org/view/journals/j-neurosurg/139/4/article-p1083.xml

Interrupted intraarterial selective cooling infusion combined ...Interrupted IA-SCI for patients with intracranial large vessel occlusion AIS symptoms treated with MT seems to be safe and associated with favorable functional ...

9.onlinelibrary.wiley.comonlinelibrary.wiley.com/doi/10.1111/cns.13883

The intra‐arterial selective cooling infusion system: A ...The neuroprotection of acute ischemic stroke patients can be achieved by intra-arterial selective cooling infusion using cold saline.

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Neuroprotective Agents for Ischemic Stroke

What You Need to Know Before You Apply

Who Is on the Research Team?

Are You a Good Fit for This Trial?

Timeline for a Trial Participant

What Are the Treatments Tested in This Trial?

Find a Clinic Near You

Who Is Running the Clinical Trial?

Published Research Related to This Trial

Citations

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