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

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ClinicalTrials.gov Identifier: NCT03792152
Recruitment Status : Not yet recruiting
First Posted : January 3, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Yuehui Yin, 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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Left Atrial Appendage Thrombosis Rivaroxaban Drug: Rivaroxaban Drug: Warfarin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : December 30, 2022


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.




Primary Outcome Measures :
  1. Number of patient who's thrombus in the left atrium or left atrial appendage is completely dissolved within 3 to 6 weeks [ Time Frame: 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 :
  1. Number of patient who's thrombus in the left atrium or left atrial appendage is completely dissolved within 12 weeks [ Time Frame: 12 weeks ]
    Transesophageal echocardiography was used to assess whether there was a left atrial appendage thrombus at 12th week after initiation of anticoagulant therapy.

  2. Size change of left atrial appendage or left atrium thrombus [ Time Frame: 12 weeks ]
    If a left atrial appendage or left atrial thrombus is detected,then the size of the thrombus is measured using echocardiography。

  3. Number of severe bleeding cases such as gastrointestinal bleeding and cerebral hemorrhage. [ Time Frame: 12 weeks ]
    Number of severe bleeding cases such as gastrointestinal bleeding and cerebral hemorrhage.

  4. Number of transient ischemic attacks (TIA) and strokes [ Time Frame: 12 weeks ]
    Number of transient ischemic attacks (TIA) and strokes



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03792152


Contacts
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Contact: ZHIYU LING, MD +8613512362075 lingzy1977@163.com
Contact: YANPING XU +86-023-63693079

Sponsors and Collaborators
The Second Affiliated Hospital of Chongqing Medical University

Publications of Results:
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Responsible Party: Yuehui Yin, professor, The Second Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier: NCT03792152     History of Changes
Other Study ID Numbers: REVIEW-AF
First Posted: January 3, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yuehui Yin, The Second Affiliated Hospital of Chongqing Medical University:
Atrial Fibrillation
Left Atrial Appendage Thrombosis
rivaroxaban
Additional relevant MeSH terms:
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Warfarin
Atrial Fibrillation
Thrombosis
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Heparin, Low-Molecular-Weight
Rivaroxaban
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors