A Prospective Randomized Controlled Trial of Rivaroxaban Versus Warfarin in Dissolving Left Atrial Appendage Thrombus in Patients With Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 主要终点
- Number of patient who's thrombus in the left atrium or left atrial appendage is completely dissolved within 3 to 6 weeks
研究概览
简要总结
The purpose of this clinical randomized trial is to evaluate the efficacy and safety of rivaroxaban compared with warfarin in dissolving the LAA thrombus in patients with atrial fibrillation.
详细描述
Left atrial appendage (LAA) thrombosis is a common complication of atrial fibrillation and will significantly increase the incidence of stroke in patients. Warfarin is a classical oral anticoagulant which can dissolve thrombus, but its clinical use has many limitations and it requires strict monitoring of coagulation. Recently, some studies have shown that NOAC (dabigatran / rivaroxaban) can dissolve left atrial appendage thrombosis. The application of rivaroxaban in the X-TRA study dissolved 41.5% of LAA thrombus after 6 weeks, indicating its potential clinical application prospects. Whether rivaroxaban is not inferior to warfarin for rapid dissolution of LAA thrombus, there is no prospective randomized controlled trial.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
After receiving the informed consent form patient, The heads of the centers randomly extracted the envelopes and patients are included in the study based on random envelope grouping results.
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
- •Get informed consent from the patient or family.
- •Non-valvular atrial fibrillation / atrial flutter.
- •The first transesophageal echocardiogram revealed a left atrial appendage thrombus (within 7 days of detection of thrombus).
- •Age at 18-80 years old.
- •CrCL≥ 30 mL/min (Cockcroft-Gault).
- •AST/ALT is less than 2 times the upper limit of normal.
- •Women of childbearing age need contraception.
排除标准
- •Pregnant or lactating woman.
- •Can't understand or follow the research plan.
- •Patients under 18 or over 80 years old.
- •Low weight (< 40 kg).
- •Previously found LAA thrombus and have taken anticoagulant drugs.
- •Patients with contraindications for anticoagulation.
- •Patients who need to use antiplatelet drugs simultaneously within 6-12 months after ACS or PCI.
- •A history of cerebral hemorrhage.
- •Patients with active bleeding.
- •Severe gastritis, gastroesophageal reflux patients.
- •Combination of P-glycoprotein inhibitors and other drugs in the presence of NOAC contraindications.
- •13.Patient with tumor. 14.Planned surgery within 3 months. 15.Other investigators believe that patients are not suitable for enrollment.
研究组 & 干预措施
rivaroxaban
After diagnosis of left atrial appendage thrombus by transesophageal echocardiography, then start with rivaroxaba 20mg qd(15mg If creatinine clearance is between 30-49 ml/min ).
干预措施: Rivaroxaban (Drug)
Warfarin
After diagnosis of left atrial appendage thrombus by transesophageal echocardiography, subcutaneous injection of low molecular weight heparin and oral warfarin treatment were started, and low molecular weight heparin was stopped after INR reached 2.
干预措施: Warfarin (Drug)
结局指标
主要结局
Number of patient who's thrombus in the left atrium or left atrial appendage is completely dissolved within 3 to 6 weeks
时间窗: 6 weeks
Transesophageal echocardiography was used to assess whether there was a left atrial appendage thrombus at 3rd, 6th week after initiation of anticoagulant therapy.
次要结局
- Number of severe bleeding cases such as gastrointestinal bleeding and cerebral hemorrhage.(12 weeks)
- Number of transient ischemic attacks (TIA) and strokes(12 weeks)
- Number of patient who's thrombus in the left atrium or left atrial appendage is completely dissolved within 12 weeks(12 weeks)
- Size change of left atrial appendage or left atrium thrombus(12 weeks)
研究者
Yuehui Yin
professor
The Second Affiliated Hospital of Chongqing Medical University