Optimal Duration of Dual Antiplatelet Therapy After Stent-assisted Coiling of Unruptured Intracranial Aneurysms: A Prospective Randomized Multicenter Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 528
- 试验地点
- 8
- 主要终点
- Incidence of thromboembolic complications
研究概览
简要总结
Comparison of duration of dual antiplatelet therapy after stent-assisted coiling of unruptured intracranial aneurysms
详细描述
The purpose of this study is to compare the incidence of thromboembolic and hemorrhagic complications between 1 and 18 months after stent-assisted coiling according to the duration of use of dual antiplatelet agents (6 months versus 12 months) after stent-assisted coiling of unruptured intracranial aneurysms to determine the optimal duration of use of dual antiplatelet agents.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects over 19 years old
- •subjects with modified Rankin Scale (mRS) ≤ 2
- •subjects with unruptured intracranial aneurysms
- •subjects with appropriated aspirin and clopidogrel reaction units after dual antiplatelet preparation (100 mg of aspirin and 75 mg of clopidogrel) for at least 5 days before procedure [measured using VerifyNow]
- •aspirin reaction unit (ARU) < 550
- •P2Y12 reaction unit (PRU): 85~219
- •subjects who agreed to this study (with informed consent)
排除标准
- •subjects with neurological deficits (mRS ≥ 3)
- •subjects with an allergic reaction to antiplatelets (aspirin and clopidogrel) or contrast
- •subjects with a high risk of hemorrhage such ICH or severe gastric ulceration
- •subjects with coagulopathy
- •subjects with thrombocytopenia (<100,000/mm3)
- •subjects with liver diseases (> 100IU/L of aspartate aminotransferase or alanine aminotransferase)
- •subjects with renal diseases (> 2mg/dL of serum creatinine)
- •subjects with underlying diseases that need to maintain dual antiplatelet drugs or anticoagulants.
- •subjects with a high risk of strokes (atrial fibrillation, over 70% cerebral artery stenosis or cerebral artery occlusion, moyamoya disease, vascular malformations, etc)
- •subjects with uncontrolled congestive heart failure or angina
- •subjects with malignant tumors
- •subjects with a positive pregnancy test (serum or urine)
- •subjects who are unconscious at the time of diagnosis.
- •subjects who are unable to complete the required follow-ups
- •subjects with life-threatening diseases
- •subjects with medical conditions with a life expectancy of less than two years
- •subjects who are determined to be disqualified by researchers
研究组 & 干预措施
short-term dual antiplatelet group
Patients with unruptured intracranial aneurysms received dual antiplatelet agents (100mg of aspirin and 75mg of clopidogrel) for at least five days before coil embolization. One day prior to coiling, aspirin reaction units (ARU) and P2Y12 reaction units (PRU) were measured using VerifyNow. Patients with proper aspirin and clopidogrel reaction units (ARU < 550 and PRU 85 ~219) will be enrolled in this study. After stent-assisted coiling, dual antiplatelet treatment continued for 6 months; after that time, this therapy will be exchanged for daily oral 100mg of aspirin for 18 months after coiling
干预措施: Aspirin 100mg (Drug)
short-term dual antiplatelet group
Patients with unruptured intracranial aneurysms received dual antiplatelet agents (100mg of aspirin and 75mg of clopidogrel) for at least five days before coil embolization. One day prior to coiling, aspirin reaction units (ARU) and P2Y12 reaction units (PRU) were measured using VerifyNow. Patients with proper aspirin and clopidogrel reaction units (ARU < 550 and PRU 85 ~219) will be enrolled in this study. After stent-assisted coiling, dual antiplatelet treatment continued for 6 months; after that time, this therapy will be exchanged for daily oral 100mg of aspirin for 18 months after coiling
干预措施: Clopidogrel 75mg (Drug)
long-term dual antiplatelet group
Patients with unruptured intracranial aneurysms received dual antiplatelet agents (100mg of aspirin and 75mg of clopidogrel) for at least five days before coil embolization. One day prior to coiling, aspirin reaction units (ARU) and P2Y12 reaction units (PRU) were measured using VerifyNow. Patients with proper aspirin and clopidogrel reaction units (ARU < 550 and PRU 85 ~219) will be enrolled in this study. After stent-assisted coiling, dual antiplatelet treatment continued for 12 months; after that time, this therapy will be exchanged for daily oral 100mg of aspirin for 18 months after coiling.
干预措施: Aspirin 100mg (Drug)
long-term dual antiplatelet group
Patients with unruptured intracranial aneurysms received dual antiplatelet agents (100mg of aspirin and 75mg of clopidogrel) for at least five days before coil embolization. One day prior to coiling, aspirin reaction units (ARU) and P2Y12 reaction units (PRU) were measured using VerifyNow. Patients with proper aspirin and clopidogrel reaction units (ARU < 550 and PRU 85 ~219) will be enrolled in this study. After stent-assisted coiling, dual antiplatelet treatment continued for 12 months; after that time, this therapy will be exchanged for daily oral 100mg of aspirin for 18 months after coiling.
干预措施: Clopidogrel 75mg (Drug)
结局指标
主要结局
Incidence of thromboembolic complications
时间窗: between 1 and 18 months after stent-assisted coil embolization
The primary outcome measure is incidence of thromboembolic complications between 1 and 18 months post-procedure.
次要结局
- Incidence of periprocedural complications(during procedure and within 1 month post-procedure)
- Incidence of hemorrhagic complications(between 1 and 18 months after stent-assisted coil embolization)
- Changes of modified Rankin scale in clinical and functional outcomes at 18 months follow up(within 18 months post-procedure)
- Incidence of unrelated complication with this study(within 18 months post-procedure)
- Changes in aspirin reaction unit and P2Y12 reaction units at 6 months follow-up by using VerifyNow(at 6 months)
- Periprocedural mortality(within 1 month)
- Comparison of mortality(between 1 and 18 months after stent-assisted coil embolization)
- Changes in radiological outcomes by Roy-Raymond grades(at 18 months)
研究者
Kwon Oki
Professor
Seoul National University Bundang Hospital