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

Primary Purpose

Atrial Fibrillation, Left Atrial Appendage Thrombosis, Rivaroxaban

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rivaroxaban
Warfarin
Sponsored by
The Second Affiliated Hospital of Chongqing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Left Atrial Appendage Thrombosis, rivaroxaban

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    rivaroxaban

    Warfarin

    Arm 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 ).

    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.

    Outcomes

    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
    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
    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
    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.
    Number of severe bleeding cases such as gastrointestinal bleeding and cerebral hemorrhage.
    Number of transient ischemic attacks (TIA) and strokes
    Number of transient ischemic attacks (TIA) and strokes

    Full Information

    First Posted
    December 31, 2018
    Last Updated
    March 18, 2019
    Sponsor
    The Second Affiliated Hospital of Chongqing Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03792152
    Brief Title
    A Trial of Rivaroxaban Versus Warfarin in Dissolving Left Atrial Appendage Thrombus in Patients With Atrial Fibrillation
    Official Title
    A Prospective Randomized Controlled Trial of Rivaroxaban Versus Warfarin in Dissolving Left Atrial Appendage Thrombus in Patients With Atrial Fibrillation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2019 (Anticipated)
    Primary Completion Date
    January 1, 2022 (Anticipated)
    Study Completion Date
    December 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The Second Affiliated Hospital of Chongqing Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrial Fibrillation, Left Atrial Appendage Thrombosis, Rivaroxaban
    Keywords
    Atrial Fibrillation, Left Atrial Appendage Thrombosis, rivaroxaban

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    ParticipantCare ProviderInvestigatorOutcomes 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.
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    rivaroxaban
    Arm Type
    Experimental
    Arm 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 ).
    Arm Title
    Warfarin
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Drug
    Intervention Name(s)
    Rivaroxaban
    Intervention 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).
    Intervention Type
    Drug
    Intervention Name(s)
    Warfarin
    Intervention Description
    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 Measure Information:
    Title
    Number of patient who's thrombus in the left atrium or left atrial appendage is completely dissolved within 3 to 6 weeks
    Description
    Transesophageal echocardiography was used to assess whether there was a left atrial appendage thrombus at 3rd, 6th week after initiation of anticoagulant therapy.
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Number of patient who's thrombus in the left atrium or left atrial appendage is completely dissolved within 12 weeks
    Description
    Transesophageal echocardiography was used to assess whether there was a left atrial appendage thrombus at 12th week after initiation of anticoagulant therapy.
    Time Frame
    12 weeks
    Title
    Size change of left atrial appendage or left atrium thrombus
    Description
    If a left atrial appendage or left atrial thrombus is detected,then the size of the thrombus is measured using echocardiography。
    Time Frame
    12 weeks
    Title
    Number of severe bleeding cases such as gastrointestinal bleeding and cerebral hemorrhage.
    Description
    Number of severe bleeding cases such as gastrointestinal bleeding and cerebral hemorrhage.
    Time Frame
    12 weeks
    Title
    Number of transient ischemic attacks (TIA) and strokes
    Description
    Number of transient ischemic attacks (TIA) and strokes
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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. 13.Patient with tumor. 14.Planned surgery within 3 months. 15.Other investigators believe that patients are not suitable for enrollment.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    ZHIYU LING, MD
    Phone
    +8613512362075
    Email
    lingzy1977@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    YANPING XU
    Phone
    +86-023-63693079

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27502860
    Citation
    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.
    Results Reference
    result

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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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