Safety and Efficacy of Adjunctive Intra-arterial Adenosine Following Successful Endovascular Thrombectomy in Patients with Large Vessel Occlusion Acute Ischemic Stroke (REACT) Trial: Rationale and Design

Abstract Background Among patients with acute ischemic stroke (AIS) secondary to large vessel occlusion (LVO) who undergo successful reperfusion following endovascular thrombectomy (EVT), only one-third are disability-free at 90 days, which may be related to persistent microvascular hypoperfusion after thrombectomy known as the “no-reflow phenomenon”. Adenosine is administered to prevent percutaneous coronary intervention (PCI)-related no-reflow through microvasculature dilation and neutrophil-mediated inflammation modulation. However, its role in in the setting of AIS has not been clearly elucidated. Objective To evaluate the safety and efficacy of adjunctive intra-arterial adenosine following successful EVT in LVO patients. Methods and design In this multicenter, open-label, randomized, phase 2 trial, we evaluated the safety and efficacy of adjunctive intra-arterial adenosine following successful EVT in AIS patients. Up to 160 eligible stroke patients with anterior intracranial large vessel occlusion presenting within 24 hours from symptom onset (time last known well) are planned to be consecutively randomized. The primary outcome was the shift in the distribution of mRS scores at 90 days. Safety outcomes included symptomatic intracranial hemorrhage (sICH) within 48 hours and mortality at 90 days. Discussions This pivotal trial will provide first-hand data on the efficacy and safety of adjunctive intra-arterial adenosine following successful EVT in patients with acute ischemic stroke due to LVO. Trial registry number ChiCTR2400092051 ( www.chictr.org.cn ).