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

NCT ID: NCT03792152

Last Updated: 2019-03-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2022-12-30

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.

Conditions

Atrial Fibrillation; Left Atrial Appendage Thrombosis; Rivaroxaban

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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 ).

Group Type: EXPERIMENTAL

Rivaroxaban

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Warfarin

Intervention Type: DRUG

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.

Interventions

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).

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Yuehui Yin

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

ZHIYU LING, MD

Role: CONTACT

lingzy1977@163.com

+8613512362075

YANPING XU

Role: CONTACT

+86-023-63693079

References

Lip GY, Hammerstingl C, Marin F, Cappato R, Meng IL, Kirsch B, van Eickels M, Cohen A; X-TRA study and CLOT-AF registry investigators. Left atrial thrombus resolution in atrial fibrillation or flutter: Results of a prospective study with rivaroxaban (X-TRA) and a retrospective observational registry providing baseline data (CLOT-AF). Am Heart J. 2016 Aug;178:126-34. doi: 10.1016/j.ahj.2016.05.007. Epub 2016 May 17.

Reference Type: RESULT

PMID: 27502860 (View on PubMed)

Other Identifiers

REVIEW-AF

Identifier Type: -

Identifier Source: org_study_id