Safety and Efficacy of Remote Ischaemic Conditioning for Acute Ischaemic Stroke Treated with Mechanical Thrombectomy (RECAST-MT): rationale and design.

rationaleAdjunctive neuroprotection is a promising strategy for improving functional recovery in patients with acute ischaemic stroke (AIS) treated with mechanical thrombectomy (MT). Remote ischaemic conditioning (RIC) has been shown to be safe and effective in patients with AIS; however, its specific impact on neurological outcomes in patients undergoing MT remains to be established.

aimTo evaluate the safety and efficacy of adjunctive RIC in improving 90-day functional outcomes in patients with AIS treated with MT, and to compare two treatment durations (14 days vs 30 days). METHODS AND

designSafety and Efficacy of Remote Ischaemic Conditioning for Acute Ischaemic Stroke Treated with Mechanical Thrombectomy (RECAST-MT) is a multicentre, randomised, controlled, open-label trial with blinded end-point assessment conducted in China. Patients with AIS caused by large-vessel occlusion in the anterior circulation who are scheduled to undergo MT will be enrolled and randomly assigned in a 1:1:1 ratio to receive 14-day RIC, 30-day RIC or standard treatment alone. To allow for early termination due to futility, an interim analysis will be conducted. Total enrolment will range from a minimum of 1526 patients (if one arm is terminated early) to a maximum of 2105 patients (if all arms reach full recruitment). RIC is performed by intermittently inflating cuffs on the upper arm to a pressure of 200 mm Hg. STUDY OUTCOMES: The primary end point is the proportion of patients achieving functional independence (modified Rankin Scale (mRS) score 0-2) at 90 days. Secondary end points include a shift analysis of mRS scores, early neurological improvement and infarct volume on imaging. The primary safety outcome is the incidence of any intracranial haemorrhage within 14 days or at discharge. DISCUSSION: The RECAST-MT trial will provide phase III evidence on the efficacy of RIC in combination with MT for patients with AIS. If successful, this approach could offer a safe, easy-to-implement and cost-effective neuroprotective therapy in this population. TRIAL REGISTRATION NUMBER: NCT06559241.