Remote Ischemic Conditioning After Stroke Trial 2: A Phase IIb Randomized Controlled Trial in Hyperacute Stroke

Area of Science:

• Neuroscience
• Cardiovascular Medicine
• Clinical Trials

Background:

• Repeated episodes of limb ischemia and reperfusion (remote ischemic conditioning [RIC]) may offer neuroprotection against ischemic reperfusion injury in the brain.
• Hyperacute stroke presents a critical window for intervention to mitigate brain damage.

Purpose of the Study:

• To evaluate the feasibility, tolerability, and safety of remote ischemic conditioning (RIC) in patients with hyperacute stroke.
• To assess the impact of RIC on specific plasma biomarkers and functional outcomes following stroke.

Main Methods:

• A phase IIb, blinded, dose-escalation, sham-controlled trial was conducted in patients with hyperacute stroke.
• Participants were randomized 1:1 to receive either RIC (four 5-minute cycles) or a sham procedure on the nonparetic upper limb within 6 hours of stroke onset.
• Feasibility, adherence, safety, plasma biomarkers (S100-ß protein, MMP-9, NSE), and functional outcomes were assessed.

Main Results:

• The trial successfully recruited 60 participants within the target timeframe, demonstrating high feasibility with no loss to follow-up.
• RIC was well-tolerated, with no significant differences in adherence, serious adverse events, or mortality compared to the sham group.
• S100-ß protein levels increased in the sham group but not in the RIC group, suggesting a potential protective effect of RIC.

Conclusions:

• Remote ischemic conditioning (RIC) is a feasible and safe intervention for patients with hyperacute stroke when administered twice daily for two days.
• The observed lack of S100-ß increase in the RIC group warrants further investigation in larger trials.
• A larger phase III trial is recommended to confirm the efficacy and neuroprotective potential of RIC in stroke patients.