The Efficacy and Safety of Tirofiban Enhanced Antiplatelet Therapy in the Treatment of Ruptured Intracranial Aneurysms With Stent

Overview

This multicenter prospective randomized controlled study will enroll patients with ruptured intracranial aneurysms receiving stent-assisted coiling across multiple Chinese medical centers. The investigators aim to evaluate the efficacy and safety of tirofiban-enhanced antiplatelet therapy versus conventional dual antiplatelet treatment on the 90-day neurological prognosis and major adverse cerebrovascular events of enrolled subjects.

Ruptured intracranial aneurysm accompanied by subarachnoid hemorrhage carries high risks of disability and mortality. Stent-assisted coiling has become a mainstream emergency interventional therapy for this condition. Conventional dual antiplatelet therapy with aspirin and clopidogrel is routinely applied perioperatively, yet clopidogrel resistance is common among Asian populations, which greatly elevates the risk of delayed cerebral infarction and poor long-term neurological recovery. Tirofiban is a rapid-onset, reversible intravenous antiplatelet agent that can effectively suppress platelet aggregation, but high-level evidence from large multicenter randomized controlled trials is still lacking to standardize its administration strategy in emergency stent-assisted embolization for ruptured intracranial aneurysms. To fill this gap in clinical evidence and optimize perioperative antithrombotic regimens, this multicenter prospective randomized controlled trial is designed to compare tirofiban-enhanced antiplatelet therapy against traditional dual antiplatelet treatment. Eligible subjects will be recruited from multiple tertiary hospitals across China. After successful stent implantation during endovascular surgery, participants will be randomly assigned to two groups in a 1:1 ratio. The experimental group will receive perioperative tirofiban combined with standard preoperative oral dual antiplatelet therapy, while the control group will be given matched volume perioperative saline plus standard oral dual antiplatelet therapy. Patients and evaluators responsible for imaging interpretation and neurological function scoring will remain blinded to group allocation to reduce assessment bias. Multiple scheduled follow-up visits will be arranged to record imaging findings, hemorrhagic and thromboembolic adverse events, and neurological function scores at preset time points. The primary endpoint focuses on patients' neurological functional prognosis 90 days after intervention, while secondary outcomes include short-term cerebral infarction incidence, aneurysm occlusion status, long-term functional recovery and all-cause mortality. Major safety indicators will monitor moderate to severe bleeding events within the early postoperative phase. This trial has obtained formal ethical approval, and standardized data management, monitoring and quality control procedures will be implemented throughout the whole research process to guarantee data authenticity and trial compliance with clinical research specifications. This is a clinical trial with a total research period of nearly three years, including the enrollment phase and long-term follow-up for each enrolled subject.