Guided Versus Standard Antiplatelet Therapy in Intracranial Aneurysm Intervention With Stents: a Cluster Randomized Controlled Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 590
- 试验地点
- 2
- 主要终点
- Ischemic events
研究概览
简要总结
The use of intracranial stents expands the possibilities for endovascular treatment of intracranial aneurysms and improves the success rate. However, it also increases the risk of ischemic complications in patients. The current standard dual antiplatelet regimen is considered crucial in reducing thrombotic events. Nevertheless, some patients exhibit resistance to antiplatelet drugs, which puts them at a higher risk of thrombotic events. In clinical practice, there is a lack of standardized platelet function testing and consensus on adjusting antiplatelet drug programs. This study conducted a multi-center, prospective cluster randomized controlled trial to investigate whether antiplatelet adjustment therapy guided by light transmittance aggregometry (LTA) detection can decrease the occurrence of ischemic events after stent implantation in patients with unruptured intracranial aneurysms. Additionally, the study aimed to establish a set of standardized antiplatelet regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
To ensure the reliability of the research results, a study committee consisting of 5 members will be formed. The committee comprised a 2-member data safety monitoring committee and a 3-member clinical event review committee. Each reported ischemic event and bleeding event were assessed independently by three members of the clinical event adjudication committee. These committee members were blinded to the treatment group assignments. Any disagreements were resolved by a third member of the clinical events adjudication committee. All five committee members reviewed and resolved any discrepancies through consensus.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with unruptured intracranial aneurysms who received intracranial stenting,
- •Standard dualantiplatelet therapy for at least 5 days before stent implantation,
- •Patients aged 18-80,
- •on the day of registration patients with a Modified Rankin Scale lower than 2,
- •patients who agree and sign the consent form.
排除标准
- •Patients with recurrent aneurysms after interventional therapy or clipping therapy,
- •Patients with a history of allergy to aspirin, clopidogrel or ticagrelor,
- •Patients who used tirofiban prophylactically before surgery,
- •Possible active bleeding Patients with high blood pressure, such as symptomatic intracranial hemorrhage or active gastric ulcer; or patients with bleeding tendency or coagulation dysfunction,
- •Any abnormal platelet count (normal value is 100-300 × 10^9/L),
- •Patients using anticoagulants,
- •Pregnant or lactating women,
- •Suffering from liver disease, kidney disease, congestive heart failure, malignant tumors and other malignant diseases.
研究组 & 干预措施
test group
Use a guided antiplatelet regimen based on LTA testing
干预措施: Adjustment of Antiplatelet Drugs (Drug)
结局指标
主要结局
Ischemic events
时间窗: 30 days after stent implantation.
ischemic stroke, transient ischemic stroke (TIA), stent thrombosis
次要结局
未报告次要终点