drugset / Trial / NCT05032781

Intra-Arterial Neuroprotective Agents and Cold Saline in Ischemic Stroke Intervention

NCT05032781

Phase 1 Withdrawn Northwell Health
NaSequentialOpen-labelTreatment

Summary

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.

Timeline

Start
2021-06-01
Primary completion
2024-09
Completion
2026-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Magnesium Sulfate Other / unclassified 2 g Other
Subject Magnesium Sulfate Other / unclassified 4 g Other
Subject Minocycline Small molecule 2 mg/kg Other
Subject Minocycline Small molecule 4 mg/kg Other
Subject Minocycline Small molecule 6 mg/kg Other

Indications