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

Not Applicable

• Conditions: Atrial Fibrillation; Rivaroxaban; Left Atrial Appendage Thrombosis
• Interventions: Drug: Rivaroxaban; Drug: Warfarin

• Registration Number: NCT03792152
• Lead Sponsor: The Second Affiliated Hospital of Chongqing Medical University

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2018-12-31
• Study First Submitted QC: 2018-12-31
• Study First Posted: 2019-01-03
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-18
• Last Update Posted: 2019-03-19
• Study Start: 2019-06-01
• Primary Completion: 2022-01-01
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rivaroxaban	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 ).
Warfarin	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.

Primary Outcome Measures

Name	Time	Method
Number of patient who's thrombus in the left atrium or left atrial appendage is completely dissolved within 3 to 6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Number of severe bleeding cases such as gastrointestinal bleeding and cerebral hemorrhage.	12 weeks	Number of severe bleeding cases such as gastrointestinal bleeding and cerebral hemorrhage.
Number of transient ischemic attacks (TIA) and strokes	12 weeks	Number of transient ischemic attacks (TIA) and strokes
Number of patient who's thrombus in the left atrium or left atrial appendage is completely dissolved within 12 weeks	12 weeks	Transesophageal echocardiography was used to assess whether there was a left atrial appendage thrombus at 12th week after initiation of anticoagulant therapy.
Size change of left atrial appendage or left atrium thrombus	12 weeks	If a left atrial appendage or left atrial thrombus is detected,then the size of the thrombus is measured using echocardiography。