NCT04135677

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)）

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 826 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Left Atrial Appendage Thrombosis
• Thrombi
• Stroke

Interventions

Type	Name	Description
DRUG	Rivaroxaban	Drug: Rivaroxaban 20mg Duration of treatment: 12 weeks(12 weeks for DAPT afterwards)
DRUG	DAPT	Drug: Aspirin 100mg and clopidogrel 75mg Duration of treatment:24 weeks

Timeline

• Start date: 2022-11-11
• Primary completion: 2024-10-01
• Completion: 2024-10-30
• First posted: 2019-10-23
• Last updated: 2022-11-15

Locations

1 site across 1 country: China