RESCUE Phase II
(2025)Objective
To evaluate the safety and efficacy of intravenous RNS60, an investigational anti-inflammatory and cytoprotective therapy, in patients with acute ischemic stroke undergoing endovascular therapy.
Study Summary
• Treatment with RNS60 alongside standard of care was safe and associated with reduced infarct growth and hospital stay duration. • High-dose RNS60 led to a 4.8-day reduction in hospitalization (P = .022) and a 50% attenuation in infarct growth (P < .05). • More patients in the high-dose group were discharged home (55% vs 21%).
Intervention
IV RNS60 (low dose: 0.5 mL/kg/h, high dose: 1.0 mL/kg/h) versus placebo, initiated before completion of EVT and continued for 48 hours.
Inclusion Criteria
Patients with acute ischemic stroke, NIHSS >5, ASPECTS >5, presence of penumbra/collaterals, and pre-stroke mRS ≤2.
Study Design
Arms: Low-dose RNS60, High-dose RNS60, Placebo
Patients per Arm: Low dose: ~27; High dose: ~27; Placebo: ~28 (total N=82)
Outcome
• Hospital stay reduced by 4.8 days in RNS60 groups (P = .022). • Infarct growth reduced by 50% in high-dose group (P < .05). • 72% of high-dose patients were independent at day 90 (vs 37% placebo). • Higher mRS 0–2 (OR 3.7), Barthel Index >95 (71% vs 43%, OR 5.8), EQ-5D-5L score (0.74 vs 0.58), and NIHSS improvement. • Similar SAE and mortality rates across groups.