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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03792152
Other study ID # REVIEW-AF
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2019
Est. completion date December 30, 2022

Study information

Verified date March 2019
Source The Second Affiliated Hospital of Chongqing Medical University
Contact ZHIYU LING, MD
Phone +8613512362075
Email lingzy1977@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date December 30, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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


Intervention

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).
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
The Second Affiliated Hospital of Chongqing Medical University

References & Publications (1)

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-TR — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patient who's thrombus in the left atrium or left atrial appendage is completely dissolved within 3 to 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. 6 weeks
Secondary Number of patient who's thrombus in the left atrium or left atrial appendage is completely dissolved within 12 weeks Transesophageal echocardiography was used to assess whether there was a left atrial appendage thrombus at 12th week after initiation of anticoagulant therapy. 12 weeks
Secondary Size change of left atrial appendage or left atrium thrombus If a left atrial appendage or left atrial thrombus is detected,then the size of the thrombus is measured using echocardiography? 12 weeks
Secondary Number of severe bleeding cases such as gastrointestinal bleeding and cerebral hemorrhage. Number of severe bleeding cases such as gastrointestinal bleeding and cerebral hemorrhage. 12 weeks
Secondary Number of transient ischemic attacks (TIA) and strokes Number of transient ischemic attacks (TIA) and strokes 12 weeks
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