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

Sponsor

The Second Affiliated Hospital of Chongqing Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT03792152

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Left Atrial Appendage Thrombosis Rivaroxaban	Drug: Rivaroxaban Drug: Warfarin	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

two groups, group one is for Rivaroxaban 20mg qd (15mg qd If creatinine clearance is between 30-49ml/min), group two is for warfarin, keep the INR between 2-3.two groups, group one is for Rivaroxaban 20mg qd (15mg qd If creatinine clearance is between 30-49ml/min), group two is for warfarin, keep the INR between 2-3.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2019

Anticipated Primary Completion Date :

Jan 1, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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 ).	Drug: 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).
Active Comparator: 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.	Drug: Warfarin 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.

Arm

Intervention/Treatment

Experimental: 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 ).

Drug: 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).

Active Comparator: 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.

Drug: Warfarin

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.

Outcome Measures

Primary Outcome Measures

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

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。
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.