Abstract
Rationale
Remote ischaemic conditioning (RIC) represents a novel neuroprotective intervention. Findings from the RIC for Acute Moderate posterior Ischaemic Stroke (RICAMIS) investigation confirmed that this approach effectively enhances 90-day neurologic recovery among patients with acute moderate ischaemic stroke within 48 hours of symptom onset. A predefined subgroup suggested more benefit from this treatment in posterior circulation stroke (PCS).
Aim
To assess the efficacy and safety of RIC applied to patients presenting with acute moderate PCS.
Sample size estimates
Up to 960 eligible participants will be recruited for hypothesis testing of superiority, with statistical power set at 80% and a two-sided α level of 0.05. Stratified variables encompass sex, age, baseline systolic blood pressure, diabetic status, baseline National Institutes of Health Stroke Scale score, symptom-to-intervention interval, aetiological classification, infarct anatomical location and reperfusion intervention status.
Methods and design
RICAMIS2 is designed as a prospective, randomised, open-label, blinded-endpoint, multicentre clinical trial. Enrolled subjects will be allocated randomly to either the investigational arm or the control arm. Participants in the investigational arm receive standard stroke care combined with twice daily RIC administration at 200 mmHg pressure, sustained for 8–12 consecutive days. Participants in the control arm receive only standard stroke care.
Study outcome
The primary effectiveness endpoint is defined as favourable functional recovery, indicated by a modified Rankin Scale score ranging from 0 to 1, assessed at 90±7 days following random assignment.
Conclusion
This investigation is expected to furnish expanded evidence supporting the utility of RIC as a supplementary neuroprotective measure in the clinical management of acute ischaemic stroke.
Trial registration number
NCT06931535
.