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

Chongqing Medical University

Status: Unknown

Conditions: Atrial Fibrillation; Rivaroxaban; Left Atrial Appendage Thrombosis

Treatments: Drug: Warfarin; Drug: Rivaroxaban

Study type: Interventional

Funder types: Other

Identifiers

NCT03792152

REVIEW-AF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

rivaroxaban

Experimental group

Description:

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 ).

Treatment:

Drug: Rivaroxaban

Warfarin

Active Comparator group

Description:

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.

Treatment:

Drug: Warfarin