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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
826
Drug: Rivaroxaban 20mg Duration of treatment: 12 weeks(12 weeks for DAPT afterwards)
Drug: Aspirin 100mg and clopidogrel 75mg Duration of treatment:24 weeks
Zhongshan Hospital, Fudan Univerisity
Shanghai, Shanghai Municipality, China
RECRUITINGPrimacy efficacy endpoint
Number of participants with major adverse events(all-cause death, stroke/TIA, systematic embolism)
Time frame: 24 weeks after LAAC
Primacy safety endpoint
Number of participants with bleeding events(major or life-threatening)
Time frame: 24 weeks after LAAC
Device-related thrombosis
Number and rates of participants with DRT on TEE
Time frame: at 12-,24-week follow-up
Stroke
Rates and distribution of participants withischemic and hemorrhagic stroke
Time frame: at 12,24-week follow-up
Bleeding
Number and rates of participants with bleeding events in varying severity
Time frame: at 12-,24-week follow-up
Death
Number and rates of cardiovascular-related/not cardiovascular-related death
Time frame: at 12-,24-week follow-up
Re-hospitalization
Number and rates of participants indicated for re-hospitalization due to cardiovascular diseases
Time frame: at 12-,24-week follow-up
Composed endpoint
Number and rates of composed endpoints(DRT, rehospitalization for cardiovascular diseases and other primary endpoints)
Time frame: at 12-,24-week follow-up
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