Neuroprotective Agents for Ischemic Stroke
Trial Summary
What is the purpose of this trial?
Ischemic stroke is the leading cause of long-term disability in the United States. Endovascular intervention with mechanical thrombectomy has become the standard of care for acute large vessel occlusion (LVO) stroke since multiple clinical trials demonstrated improved long-term clinical outcomes with treatment. However, despite high rates of successful vessel recanalization and thus reperfusion of ischemic brain tissue in current practice, many patients continue to suffer debilitating strokes and poor long-term functional outcome. Pharmacologic neuroprotection could potentially present a means of addressing this mismatch in radiologic vs. clinical outcomes by protecting and salvaging damaged brain tissue. Intra-arterial delivery of a cocktail of neuroprotective therapy at the time of endovascular reperfusion would provide immediate, targeted therapy directly to the damaged brain territory. Hypothermia, minocycline and magnesium can target multiple facets of the complex ischemic injury cascade, and have each demonstrated neuroprotection in multiple preclinical models. This is a phase I trial that aims to demonstrate safety and feasibility of administering cold saline, minocycline, and magnesium sulfate intra-arterially immediately after thrombectomy in stroke interventions.
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.
What data supports the idea that Neuroprotective Agents for Ischemic Stroke is an effective treatment?
The available research shows mixed results for the effectiveness of Neuroprotective Agents for Ischemic Stroke. In rats, a combination of cold saline and magnesium sulfate reduced brain damage significantly. However, in humans, magnesium sulfate alone did not generally improve outcomes after a stroke, except in a small group of ischemic stroke patients. Minocycline showed promise in improving outcomes and reducing disability scores in stroke patients. Overall, while some studies show potential benefits, the effectiveness of these treatments varies, and more research is needed to confirm their benefits.12345
What safety data exists for neuroprotective agents in ischemic stroke treatment?
The safety data for neuroprotective agents such as intra-arterial cold saline, minocycline, and magnesium sulfate in ischemic stroke treatment is varied. Minocycline has shown a good safety profile in early phase clinical trials and animal models, demonstrating neuroprotective effects and improved outcomes. Magnesium sulfate, however, did not show significant improvement in functional outcomes or mortality in a meta-analysis of clinical trials, although some benefits were noted in specific subgroups like ischemic stroke patients. Overall, minocycline appears to have a more favorable safety and efficacy profile compared to magnesium sulfate.12567
Research Team
Thomas W Link, MD, MS
Principal Investigator
Northwell Health
Eligibility Criteria
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
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Intra-arterial administration of cold saline, minocycline, and magnesium sulfate immediately after thrombectomy
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
Treatment Details
Interventions
- Intra-arterial cold saline, minocycline, and magnesium (Neuroprotective Agent)
Intra-arterial cold saline, minocycline, and magnesium is already approved in China for the following indications:
- Ischemic stroke
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwell Health
Lead Sponsor