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

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)）

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Left Atrial Appendage Thrombosis; Thrombi
• Intervention / Treatment: Drug: DAPT; Drug: Rivaroxaban

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.

• Study Type: Interventional
• Enrollment (Anticipated): 826
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: XIAOCHUN ZHANG, DR; Phone Number: 15002121366; Email: 514864787@qq.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hospital, Fudan Univerisity
      • Contact: XIAOCHUN ZHANG, DR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: DAPT group; asprin 100mg qd together clopidogrel 75mg for 24 weeks	Drug: DAPT; Drug: Aspirin 100mg and clopidogrel 75mg Duration of treatment:24 weeks; Other Names: dual antiplatelet therapy
EXPERIMENTAL: Anticoagulation group; rivaroxaban 20mg qd for for 12 weeks and continued DAPT(asprin 100mg qd together clopidogrel 75mg) for 24 weeks	Drug: Rivaroxaban; Drug: Rivaroxaban 20mg Duration of treatment: 12 weeks(12 weeks for DAPT afterwards); Other Names: new oral anticoagulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primacy efficacy endpoint	Number of participants with major adverse events(all-cause death, stroke/TIA, systematic embolism)	24 weeks after LAAC
Primacy safety endpoint	Number of participants with bleeding events(major or life-threatening)	24 weeks after LAAC

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device-related thrombosis	Number and rates of participants with DRT on TEE	at 12-,24-week follow-up
Stroke	Rates and distribution of participants withischemic and hemorrhagic stroke	at 12,24-week follow-up
Bleeding	Number and rates of participants with bleeding events in varying severity	at 12-,24-week follow-up
Death	Number and rates of cardiovascular-related/not cardiovascular-related death	at 12-,24-week follow-up
Re-hospitalization	Number and rates of participants indicated for re-hospitalization due to cardiovascular diseases	at 12-,24-week follow-up
Composed endpoint	Number and rates of composed endpoints(DRT, rehospitalization for cardiovascular diseases and other primary endpoints)	at 12-,24-week follow-up

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 11, 2022
• Primary Completion (ANTICIPATED): October 1, 2024
• Study Completion (ANTICIPATED): October 30, 2024

Study Registration Dates

• First Submitted: October 20, 2019
• First Submitted That Met QC Criteria: October 20, 2019
• First Posted (ACTUAL): October 23, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 10, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban
• Other Study ID Numbers: DRXCZ

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No