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))
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Zhongshan Hospital, Fudan Univerisity | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Zhongshan Hospital |
China,
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 |
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