A Trial of Rivaroxaban Versus Warfarin in Dissolving Left Atrial Appendage Thrombus in Patients With Atrial Fibrillation

A Prospective Randomized Controlled Trial of Rivaroxaban Versus Warfarin in Dissolving Left Atrial Appendage Thrombus in Patients With Atrial Fibrillation

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.

Inclusion Criteria:

1. Get informed consent from the patient or family.
2. Non-valvular atrial fibrillation / atrial flutter.
3. The first transesophageal echocardiogram revealed a left atrial appendage thrombus (within 7 days of detection of thrombus).
4. Age at 18-80 years old.
5. CrCL≥ 30 mL/min (Cockcroft-Gault).
6. AST/ALT is less than 2 times the upper limit of normal.
7. Women of childbearing age need contraception.

Exclusion Criteria:

1. Pregnant or lactating woman.
2. Can't understand or follow the research plan.
3. Patients under 18 or over 80 years old.
4. Low weight (< 40 kg).
5. Previously found LAA thrombus and have taken anticoagulant drugs.
6. Patients with contraindications for anticoagulation.
7. Patients who need to use antiplatelet drugs simultaneously within 6-12 months after ACS or PCI.
8. A history of cerebral hemorrhage.
9. Patients with active bleeding.
10. Severe gastritis, gastroesophageal reflux patients.
11. 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.