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Neuroprotective Agent

Neuroprotective Agents for Ischemic Stroke

Phase 1

Recruiting

Led By Thomas W Link, MD, MS

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Angiography must reveal a thromboembolism which is completely occluding flow within the intracranial portion of the internal carotid artery, the M1 or proximal M2 portions of the middle cerebral artery

Participants must meet criteria for intra-arterial thrombectomy as determined and documented by the Stroke Neurology and Interventional Neuroradiology attending physicians at Northshore University Hospital

Must not have

Therapeutic anticoagulation prior to presentation

Patients with a known prior diagnosis of heart block or prior myocardial infarction (increased risk of adverse reaction to MgSO4)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 24 hours of treatment

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing whether it is safe to give patients a cocktail of neuroprotective drugs immediately after they have a stroke, in order to try to improve long-term outcomes.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions related to cold infusion such as shivering or discomfort at injection site; allergic responses; possible impact on kidney function from magnesium sulfate; and typical drug-related risks like nausea associated with minocycline.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I have been diagnosed with a stroke caused by a blocked large blood vessel, confirmed by the Stroke Neurology team.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been on blood thinners before coming here.

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

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

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I have a major blood vessel blockage in my brain.

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I am allergic to contrast dye, minocycline, or magnesium sulfate.

Select...

My liver is not severely impaired.

Select...

I have been diagnosed with increased brain pressure without a known cause.

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My kidney function is reduced with creatinine over 2.5 mg/dL.

Select...

I have been diagnosed with systemic lupus erythematosus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours after procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours after procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours after procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Intracranial hemorrhage

Presence of serious adverse event

Secondary study objectives

Functional outcome

Infarct volume

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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."

0 / 12Eligibility criteria met