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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAPT group | Active Comparator | asprin 100mg qd together clopidogrel 75mg for 24 weeks |
|
| Anticoagulation group | Experimental | rivaroxaban 20mg qd for for 12 weeks and continued DAPT(asprin 100mg qd together clopidogrel 75mg) for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban | Drug | Drug: Rivaroxaban 20mg Duration of treatment: 12 weeks(12 weeks for DAPT afterwards) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| XIAOCHUN ZHANG, DR | Contact | 15002121366 | 514864787@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| JUNBO GE, PHD | Fudan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan Univerisity | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002561 | Cerebrovascular Disorders |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
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| DAPT | Drug | Drug: Aspirin 100mg and clopidogrel 75mg Duration of treatment:24 weeks |
|
|
| 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 |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |