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Clinical Outcomes Between Anticoagulation and DAPT Therapy in AF Patients Successfully Undergoing LAAO

Primary Purpose

Left Atrial Appendage Thrombosis, Thrombi, Stroke

Status

Recruiting

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Rivaroxaban

DAPT

About this trial

This is an interventional prevention trial for Left Atrial Appendage Thrombosis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Successful transcatheter LAAC using LAMBRE with COST criteria met by intra-procedural TEE and LAA angiography;
Cha2ds2-Vasc2 score≥2 and or Has-bled score≥3(with contraindication or self-refusal to long-term administration of oral anticoagulants);
Age18-85 years old;
Life expectancy≥1 year;
Written informed consent obtained;

Exclusion Criteria:

• Prior history of cardiac surgery or with need for intervention in limited intervals;
Intolerant of TEE or with clinical contraindications for TEE
Detection of LAA/LA thrombus prior to the procedure;
Anteroposterior diameter of LAA≥60mm according to TTE
Impairment of renal function: eGFR≤15ml/min and/or creatinine level≥200μmol/L;
Patients with hepatic disease that is associated with abnormal blood coagulation(cirrhosis: Child Pugh B an C);
PLT ≤ 50*10^9/L;
LVEF≤35% and/or NYHA≥IV；
Allergies or contraindications to antiplatelet or anticoagulation therapy;
At high risk of major bleedin(such as gastrointestinal ulcer at present or recently, malignant tumor with high risk of hemorrhage, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, angioaneurysms or major intraspinal or intracerebral vascular malformations, et al)
Patients with requirement for anticoagulation therapy due to other diseases besides atrial fibrillation (such as after mechanical valve replacement, spontaneous or recurrent venous thromboembolism, etc.);
Occurrence of severe pericardial tamponade, major hemorrhage and other life-threatening complications after left atrial appendage closure;
Combined with other basic complications necessary to take drugs that may affect the effect of anticoagulation and antithrombotic regimen in this study(such as pyrrole antifungal agent, human acquired immunodeficiency virus (HIV) protease inhibitor, anti arrhythmia drug dronedarone, powerful cytochrome enzyme CYP3A4 inducer including rifampicin, phenytoin sodium, carbamazepine, phenobarbital, and other anticoagulants).
Enrolled in other clinical studies in progress;
Researches think that the patient is not suitable to participate in this study.

Sites / Locations

Zhongshan Hospital, Fudan UniverisityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

DAPT group

Anticoagulation group

Arm Description

asprin 100mg qd together clopidogrel 75mg for 24 weeks

rivaroxaban 20mg qd for for 12 weeks and continued DAPT(asprin 100mg qd together clopidogrel 75mg) for 24 weeks

Outcomes

Primary Outcome Measures

Primacy efficacy endpoint

Number of participants with major adverse events(all-cause death, stroke/TIA, systematic embolism)

Primacy safety endpoint

Number of participants with bleeding events(major or life-threatening)

Secondary Outcome Measures

Device-related thrombosis

Number and rates of participants with DRT on TEE

Stroke

Rates and distribution of participants withischemic and hemorrhagic stroke

Bleeding

Number and rates of participants with bleeding events in varying severity

Death

Number and rates of cardiovascular-related/not cardiovascular-related death

Re-hospitalization

Number and rates of participants indicated for re-hospitalization due to cardiovascular diseases

Composed endpoint

Number and rates of composed endpoints(DRT, rehospitalization for cardiovascular diseases and other primary endpoints)

Full Information

NCT ID

NCT04135677

First Posted

October 20, 2019

Last Updated

November 10, 2022

Sponsor

Shanghai Zhongshan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04135677

Brief Title

Clinical Outcomes Between Anticoagulation and DAPT Therapy in AF Patients Successfully Undergoing LAAO

Official Title

A Multi-center Randomized Controlled Study of High/Low-dosage Rivaroxaban Compared With DAPT After Left Atrial Appendage Occulsion in Patients With Non-valvular Atrial Fibrillation（ESCORT-AF Study(B)）

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 11, 2022 (Actual)

Primary Completion Date

October 1, 2024 (Anticipated)

Study Completion Date

October 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Zhongshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The objective of this study is to assess the efficacy and safety different dosage of rivaroxaban application versus dual antiplatelet therapy after successful closure of left atrial appendage using the LAMBRE device.

Detailed Description

Transcatheter left atrial appendage occlusion(LAAO) has emerged as an effective alternative for preventing thromboembolic events in patients with nonvalvular atrial fibrillation. The contemporary strategy for post-implantation antithrombotic medication therapy derived from several initial industrialized authoritative researches, demonstrated as 45 days for anticoagulation and prolonged DOAC for 6 months. In spite of the increasing experience of operators and arrival of new technologies, the rates of DRT still maintained. Therefore, whether altered medication therapy post-implantation attracted overwide attention. Nowadays, new oral anticoagulation such as rivaroxaban, dabigatran has evolved empirically and successively has been applied for days-weeks anticoagulation therapy following LAAO ,yet, the specific recommended dosage remained unclear. Therefore, the objective of the study is to compare the effects of different dosage of rivaroxaban for short-term(12 weeks) anticoagulation therapy versus DAPT for post-LAAO anti-thrombotic therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Left Atrial Appendage Thrombosis, Thrombi, Stroke

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

826 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DAPT group

Arm Type

Active Comparator

Arm Description

asprin 100mg qd together clopidogrel 75mg for 24 weeks

Arm Title

Anticoagulation group

Arm Type

Experimental

Arm Description

rivaroxaban 20mg qd for for 12 weeks and continued DAPT(asprin 100mg qd together clopidogrel 75mg) for 24 weeks

Intervention Type

Drug

Intervention Name(s)

Rivaroxaban

Other Intervention Name(s)

new oral anticoagulation

Intervention Description

Drug: Rivaroxaban 20mg Duration of treatment: 12 weeks(12 weeks for DAPT afterwards)

Intervention Type

Drug

Intervention Name(s)

DAPT

Other Intervention Name(s)

dual antiplatelet therapy

Intervention Description

Drug: Aspirin 100mg and clopidogrel 75mg Duration of treatment:24 weeks

Primary Outcome Measure Information:

Title

Primacy efficacy endpoint

Description

Number of participants with major adverse events(all-cause death, stroke/TIA, systematic embolism)

Time Frame

24 weeks after LAAC

Title

Primacy safety endpoint

Description

Number of participants with bleeding events(major or life-threatening)

Time Frame

24 weeks after LAAC

Secondary Outcome Measure Information:

Title

Device-related thrombosis

Description

Number and rates of participants with DRT on TEE

Time Frame

at 12-,24-week follow-up

Title

Stroke

Description

Rates and distribution of participants withischemic and hemorrhagic stroke

Time Frame

at 12,24-week follow-up

Title

Bleeding

Description

Number and rates of participants with bleeding events in varying severity

Time Frame

at 12-,24-week follow-up

Title

Death

Description

Number and rates of cardiovascular-related/not cardiovascular-related death

Time Frame

at 12-,24-week follow-up

Title

Re-hospitalization

Description

Number and rates of participants indicated for re-hospitalization due to cardiovascular diseases

Time Frame

at 12-,24-week follow-up

Title

Composed endpoint

Description

Number and rates of composed endpoints(DRT, rehospitalization for cardiovascular diseases and other primary endpoints)

Time Frame

at 12-,24-week follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Successful transcatheter LAAC using LAMBRE with COST criteria met by intra-procedural TEE and LAA angiography; Cha2ds2-Vasc2 score≥2 and or Has-bled score≥3(with contraindication or self-refusal to long-term administration of oral anticoagulants); Age18-85 years old; Life expectancy≥1 year; Written informed consent obtained; Exclusion Criteria: • Prior history of cardiac surgery or with need for intervention in limited intervals; Intolerant of TEE or with clinical contraindications for TEE Detection of LAA/LA thrombus prior to the procedure; Anteroposterior diameter of LAA≥60mm according to TTE Impairment of renal function: eGFR≤15ml/min and/or creatinine level≥200μmol/L; Patients with hepatic disease that is associated with abnormal blood coagulation(cirrhosis: Child Pugh B an C); PLT ≤ 50*10^9/L; LVEF≤35% and/or NYHA≥IV； Allergies or contraindications to antiplatelet or anticoagulation therapy; At high risk of major bleedin(such as gastrointestinal ulcer at present or recently, malignant tumor with high risk of hemorrhage, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, angioaneurysms or major intraspinal or intracerebral vascular malformations, et al) Patients with requirement for anticoagulation therapy due to other diseases besides atrial fibrillation (such as after mechanical valve replacement, spontaneous or recurrent venous thromboembolism, etc.); Occurrence of severe pericardial tamponade, major hemorrhage and other life-threatening complications after left atrial appendage closure; Combined with other basic complications necessary to take drugs that may affect the effect of anticoagulation and antithrombotic regimen in this study(such as pyrrole antifungal agent, human acquired immunodeficiency virus (HIV) protease inhibitor, anti arrhythmia drug dronedarone, powerful cytochrome enzyme CYP3A4 inducer including rifampicin, phenytoin sodium, carbamazepine, phenobarbital, and other anticoagulants). Enrolled in other clinical studies in progress; Researches think that the patient is not suitable to participate in this study.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

XIAOCHUN ZHANG, DR

Phone

15002121366

514864787@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

JUNBO GE, PHD

Organizational Affiliation

Fudan University

Official's Role

Study Chair

Facility Information:

Facility Name

Zhongshan Hospital, Fudan Univerisity

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

XIAOCHUN ZHANG, DR

12. IPD Sharing Statement

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Clinical Outcomes Between Anticoagulation and DAPT Therapy in AF Patients Successfully Undergoing LAAO

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