Effectiveness and Safety of PERIoperative Factor Xa Inhibitor Discontinuation in Patients With Atrial Fibrillation Who Undergoing Minor Bleeding Risk Elective Procedure or Surgery: A Prospective, Multicenter, Noninterventional Study (PERIXa Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,500
- 试验地点
- 2
- 主要终点
- 30-day major bleeding
研究概览
简要总结
This study aims to analyze the safety and effectiveness of the discontinuation/resumption protocol of factor Xa inhibitors before and after invasive procedures/surgeries in non-valvular atrial fibrillation patients who are at risk of minor bleeding in actual clinical settings
详细描述
- Study design This is a multicenter, non-randomized, investigator-initiated prospective cohort study. The study will analyze the bleeding risk and incidence of cardiovascular events according to the discontinuation/resumption of factor Xa inhibitors before and after invasive procedures/surgeries in non-valvular atrial fibrillation patients who are prescribed factor Xa inhibitors for stroke prevention and have minor bleeding risk.
- Study population Patients who are over 20 years old, have non-valvular atrial fibrillation, and are taking rivaroxaban, apixaban, or edoxaban (active ingredients), and are facing a procedure defined as having minor bleeding risk.
- Study protocol For patients with non-valvular atrial fibrillation who are prescribed rivaroxaban, apixaban, or edoxaban for stroke prevention and are at risk of minor bleeding, when they visit the prescribing physician (physician A) for consultation and to obtain a medical opinion regarding the discontinuation/resumption of the medication in relation to an invasive procedure, the physician will explain the protocol for discontinuing/resuming the medication and provide a written explanation to ensure that the patient fully understands it.
In addition, the physician in charge of the procedure (physician B) will be notified that the patient has enrolled in this study and will collect information on 1) the type of surgery or procedure performed, and 2) physician B's opinion on the severity of procedure-related bleeding. Thromboembolic and bleeding events will be assessed through patient follow-up 30 days after the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- 否
入选标准
- •Aged >20 years
- •With rivaroxaban, apixaban, or edoxaban
- •History of non-valvular atrial fibrillation
- •Scheduled minor bleeding risk procedure(s) (dental procedure, cataract/glaucoma surgery, diagnostic GI endoscopy)
排除标准
- •Pregnancy
- •With rivaroxaban or edoxaban at afternoon
- •Mental disorder
- •Contraindication to rivaroxaban, apixaban, edoxaban
- •Moderate or severe valvular heart disease, or with prosthetic heart valves
- •With antiplatelet drugs
- •History of systemic embolism or ischemic stroke within the last 12 months
- •scheduled therapeutic endoscopic procedure(s)
研究组 & 干预措施
Periprocedural management of FXa-inhibitor group
Hold and resume factor Xa inhibitor during perioperative/periprocedural period according to predefined protocol.
干预措施: Factor Xa Inhibitor (Drug)
结局指标
主要结局
30-day major bleeding
时间窗: Within 30 days after the operation/procedure
30-day major bleeding
次要结局
- 30-day stroke or systemic embolism(Within 30 days after the operation/procedure)
- 30-day death from any cause, stroke or systemic embolism(Within 30 days after the operation/procedure)
- 30-day composite of major bleeding and clinically relevant non major bleeding (CRNMB), and any bleeding(Within 30 days after the operation/procedure)
研究者
Eue-Keun Choi
Professor
Seoul National University Hospital
