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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
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).
After the diagnosis of left atrial appendage thrombus by transesophageal echocardiography, subcutaneous injection of low molecular weight heparin (4000iu q12h) and oral warfarin treatment were started, and low molecular weight heparin was stopped after INR reached 2.
Number of patient who's thrombus in the left atrium or left atrial appendage is completely dissolved within 3 to 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.
Time frame: 6 weeks
Number of patient who's thrombus in the left atrium or left atrial appendage is completely dissolved within 12 weeks
Transesophageal echocardiography was used to assess whether there was a left atrial appendage thrombus at 12th week after initiation of anticoagulant therapy.
Time frame: 12 weeks
Size change of left atrial appendage or left atrium thrombus
If a left atrial appendage or left atrial thrombus is detected,then the size of the thrombus is measured using echocardiography。
Time frame: 12 weeks
Number of severe bleeding cases such as gastrointestinal bleeding and cerebral hemorrhage.
Number of severe bleeding cases such as gastrointestinal bleeding and cerebral hemorrhage.
Time frame: 12 weeks
Number of transient ischemic attacks (TIA) and strokes
Number of transient ischemic attacks (TIA) and strokes
Time frame: 12 weeks
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