Comparison of Dual-Antiplatelet and Triple-Antiplatelet Preparation Using P2Y12 Assay in Patients With High On-Treatment Platelet Reactivity Undergoing Stent-Assisted Coil Embolization for An Unruptured Intracranial Aneurysm
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Incidence of hemorrhagic complications between 2 arms
研究概览
简要总结
Perform a randomized comparison study of dual-antiplatelet (aspirin, prasugrel) and triple-antiplatelet (aspirin, clopidogrel, and cilostazol) preparation using P2Y12 assay in patients with high on-treatment platelet reactivity undergoing stent-assisted coil embolization for an unruptured intracranial aneurysm
详细描述
Comparison between dual-antiplatelet and triple-platelet preparation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with clopidogrel resistance (greater than 220 P2Y12 reaction units using VerifyNow)
- •patients with unruptured intracranial aneurysms
- •patients over 20 years old
- •patients who can communicate with each other
- •patients who agreed to this study (with informed consent)
排除标准
- •patients with recurrent aneurysms after coiling or clipping
- •patients with allergic reaction to antiplatelets
- •patients with high risks of hemorrhage
- •patients with coagulopathy
- •patients with thrombocytopenia (<100,000/mm3)
- •patients with liver disease (> 100 of aspartate aminotransferase or alanine aminotransferase)
- •patients with renal disease (> 2mg/dL of serum creatinine)
- •patients with uncontrolled heart failure or angina
- •patients with malignant tumor
- •pregnant patients
- •patients with past history that may associated with headache, including subarachnoid hemorrhage, head trauma, intracerebral hemorrhage, trigeminal neuralgia, arteriovenous malformation, brain tumor)
- •Patients who are determined to be disqualified by researchers
研究组 & 干预措施
dual-antiplatelet
Patients with unruptured aneurysms received dual antiplatelet agents (100 mg of aspirin and 75 mg of clopidogrel) for at least five days before embolization. One day prior to coil embolization, P2Y12 reaction units were measured using VerifyNow. Patients with clopidogrel resistance (greater than 220 PRU) received prasugrel 20mg. After that, dual-antiplatelet (aspirin 100mg & prasugrel 5mg) treatment continued for 3 months through study completion.
干预措施: Aspirin (Drug)
dual-antiplatelet
Patients with unruptured aneurysms received dual antiplatelet agents (100 mg of aspirin and 75 mg of clopidogrel) for at least five days before embolization. One day prior to coil embolization, P2Y12 reaction units were measured using VerifyNow. Patients with clopidogrel resistance (greater than 220 PRU) received prasugrel 20mg. After that, dual-antiplatelet (aspirin 100mg & prasugrel 5mg) treatment continued for 3 months through study completion.
干预措施: Prasugrel (Drug)
triple-antiplatelet
Patients with unruptured aneurysms received dual antiplatelet agents (100 mg of aspirin and 75 mg of clopidogrel) for at least five days before embolization. One day prior to coil embolization, P2Y12 reaction units (PRU) were measured using VerifyNow. Patients with clopidogrel resistance (greater than 220 PRU) received cilostazol 200mg. After that, triple-antiplatelet (aspirin 100mg, clopidogrel 75mg, and cilostazol 200mg) treatment continued for 3 months through study completion.
干预措施: Aspirin (Drug)
triple-antiplatelet
Patients with unruptured aneurysms received dual antiplatelet agents (100 mg of aspirin and 75 mg of clopidogrel) for at least five days before embolization. One day prior to coil embolization, P2Y12 reaction units (PRU) were measured using VerifyNow. Patients with clopidogrel resistance (greater than 220 PRU) received cilostazol 200mg. After that, triple-antiplatelet (aspirin 100mg, clopidogrel 75mg, and cilostazol 200mg) treatment continued for 3 months through study completion.
干预措施: Clopidogrel (Drug)
triple-antiplatelet
Patients with unruptured aneurysms received dual antiplatelet agents (100 mg of aspirin and 75 mg of clopidogrel) for at least five days before embolization. One day prior to coil embolization, P2Y12 reaction units (PRU) were measured using VerifyNow. Patients with clopidogrel resistance (greater than 220 PRU) received cilostazol 200mg. After that, triple-antiplatelet (aspirin 100mg, clopidogrel 75mg, and cilostazol 200mg) treatment continued for 3 months through study completion.
干预措施: Cilostazol (Drug)
结局指标
主要结局
Incidence of hemorrhagic complications between 2 arms
时间窗: through study completion (for 3 months)
check minor and major hemorrhagic complications of intra- and post-procedures
次要结局
- Change of the level of P2Y12(through study completion (for 3 months))
- mortality between 2 arms(through study completion (for 3 months))
- Incidence of thromboembolic complications between 2 arms(through study completion (for 3 months))