Guided versus standard antiplatelet therapy in patients undergoing interventional intracranial aneurysm treatment using stents: protocol of a cluster randomized controlled cohort study

BackgroundThe goal of standard dual antiplatelet therapy (SDAT) in patients undergoing endovascular interventional treatment of intracranial aneurysms is to prevent thrombosis; however, some patients have a poor response to these drugs, which increases the risk of cerebral infarction. This study aims to examine whether adjusting antiplatelet therapy based on light transmission aggregometry (LTA) can reduce the incidence of ischemic events compared with SDAT. MethodsWe will conduct a cluster randomized controlled trial using 16 treatment teams from eight hospitals in mainland China, enrolling 590 patients with unruptured intracranial aneurysms treated using endovascular stent placement. The treatment teams serving as clusters will be randomly assigned to either the test or control group at a 1:1 ratio. Test group patients will receive an antiplatelet regimen guided by LTA. Control group patients will receive SDAT. Patients will be followed for 1 month after the treatment period. The primary outcome measure is cerebral ischemic events within 30 days of stent placement, including stent thrombosis, ischemic stroke, and transient ischemic attack. The safety measure is all bleeding events within 30 days of treatment. DiscussionThe trial aims to determine whether LTA-guided antiplatelet therapy reduces the incidence of ischemic events without increasing the risk of bleeding in patients with intracranial aneurysms treated with endovascular stenting. Completion of this clinical trial may provide an individualized safe and effective regimen for antiplatelet therapy. Trial registration ClinicalTrials.gov, NCT05825391. Registered on April 11, 2023. What is already known on this topicDual antiplatelet therapy is administered to reduce thrombotic events in neurointerventional therapy of intracranial aneurysms. Platelet function testing is used to evaluate the antiplatelet effect of aspirin and clopidogrel. What this study addsThe trial aims to determine whether LTA-guided antiplatelet therapy reduces the incidence of ischemic events without increasing the risk of bleeding in patients with intracranial aneurysms treated with endovascular stenting. How this study might affect research, practice or policyFor stent neurointerventional therapy of unruptured intracranial aneurysms, this study could provide a promising method for adjusting appropriate antiplatelet therapy.