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

Stroke Clinical Trial

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)）

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04135677
• Other study ID #: DRXCZ
• Status: Recruiting
• Phase: Phase 4
• Start date: November 11, 2022
• Est. completion date: October 30, 2024

Study information

• Verified date: November 2022
• Source: Shanghai Zhongshan Hospital
• Contact: XIAOCHUN ZHANG, DR
• Phone: 15002121366
• Email: 514864787[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 826
• Est. completion date: October 30, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Left Atrial Appendage Thrombosis
• Stroke
• Thrombi
• Thrombosis

Intervention

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

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan Univerisity	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primacy efficacy endpoint	Number of participants with major adverse events(all-cause death, stroke/TIA, systematic embolism)	24 weeks after LAAC
Primary	Primacy safety endpoint	Number of participants with bleeding events(major or life-threatening)	24 weeks after LAAC
Secondary	Device-related thrombosis	Number and rates of participants with DRT on TEE	at 12-,24-week follow-up
Secondary	Stroke	Rates and distribution of participants withischemic and hemorrhagic stroke	at 12,24-week follow-up
Secondary	Bleeding	Number and rates of participants with bleeding events in varying severity	at 12-,24-week follow-up
Secondary	Death	Number and rates of cardiovascular-related/not cardiovascular-related death	at 12-,24-week follow-up
Secondary	Re-hospitalization	Number and rates of participants indicated for re-hospitalization due to cardiovascular diseases	at 12-,24-week follow-up
Secondary	Composed endpoint	Number and rates of composed endpoints(DRT, rehospitalization for cardiovascular diseases and other primary endpoints)	at 12-,24-week follow-up