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Rationale and design of VENTURE-AF: a randomized, open-label, active-controlled multicenter study to evaluate the safety of rivaroxaban and vitamin K antagonists in subjects undergoing catheter ablation for atrial fibrillation

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机构: [1]St Davids Med Ctr, Texas Cardiac Arrhythmia Inst, Austin, TX 78705 USA; [2]Penn State Univ, Coll Med, Inst Heart & Vasc, Hershey, PA 17033 USA; [3]Univ Milan, Arrhythmia & Electrophysiol Ctr, IRCCS Policlin San Donato, I-20097 San Donato Milanese, Milan, Italy; [4]Goethe Univ Frankfurt, Div Clin Electrophysiol, Dept Cardiol, D-60590 Frankfurt, Germany; [5]Hosp Univ Penn, Cardiovasc Div, Sect Cardiac Electrophysiol, Dept Med, Philadelphia, PA 19104 USA; [6]Loyola Univ, Med Ctr, Dept Med, Cardiovasc Inst, Maywood, IL 60153 USA; [7]Janssen Res & Dev LLC, Raritan, NJ 08869 USA; [8]Capital Med Univ, Beijing An Zhen Hosp, Dept Cardiol, Atrial Fibrillat Ctr, Beijing 100029, Peoples R China; [9]Bayer HealthCare Pharmaceut, Global Med Affairs Xarelto, Beijing 100020, Peoples R China; [10]Imperial NHS Trust, St Marys Hosp, London W1G 7HJ, England; [11]Janssen Sci Affairs LLC, Raritan, NJ 08869 USA; [12]St Davids Med Ctr, Texas Cardiac Arrhythmia Inst, 3000 N IH35,Suite 700, Austin, TX 78705 USA
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关键词: Atrial fibrillation Catheter ablation Rivaroxaban Vitamin K antagonist

摘要:
To evaluate the safety of uninterrupted rivaroxaban, a novel oral anticoagulant that directly inhibits factor Xa, and a vitamin K antagonist (VKA) in eligible adult patients with nonvalvular AF (NVAF) who are scheduled for a catheter ablation. This is a prospective, randomized, open-label, active-controlled, global multicenter safety study of up to 250 randomized patients. Eligible patients with paroxysmal or persistent NVAF, a left ventricular ejection fraction > 40 %, and a creatinine clearance > 50 mL/min will be randomized 1:1 to rivaroxaban 20 mg orally once daily or to dose-adjusted oral VKA (recommended international normalized ratio (INR) 2.0-3.0) and stabilized on anticoagulation therapy for 1-7 days (if no intracardiac thrombus on transesophageal echocardiogram (TEE) immediately prerandomization/post-randomization or if 3 weeks of sufficient anticoagulation is documented) or for 4-5 weeks (if no TEE, no documented 3 weeks of sufficient anticoagulation, or by patient choice). During catheter ablation, heparin will be administered (ACT-targeted range = 300-400 s) after catheter ablation, and VKA will be managed per usual care. The next dose of rivaroxaban will be provided at least 6 h after establishment of hemostasis. The primary endpoint will be the incidence of post-procedure major bleeding events observed during the first 30 +/- 5 days post-ablation. Secondary endpoints will include post-procedure thromboembolic events, additional bleeding, time-to-event, and medication adherence. This study is intended to provide information about the safety characteristics of rivaroxaban in patients with NVAF undergoing catheter ablation.

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出版当年[2013]版:
大类 | 4 区 医学
小类 | 4 区 心脏和心血管系统
最新[2023]版:
大类 | 4 区 医学
小类 | 4 区 心脏和心血管系统
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出版当年[2012]版:
Q3 CARDIAC & CARDIOVASCULAR SYSTEMS
最新[2023]版:
Q3 CARDIAC & CARDIOVASCULAR SYSTEMS

影响因子: 最新[2023版] 最新五年平均 出版当年[2012版] 出版当年五年平均 出版前一年[2011版] 出版后一年[2013版]

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第一作者机构: [2]Penn State Univ, Coll Med, Inst Heart & Vasc, Hershey, PA 17033 USA;
通讯作者:
通讯机构: [1]St Davids Med Ctr, Texas Cardiac Arrhythmia Inst, Austin, TX 78705 USA; [12]St Davids Med Ctr, Texas Cardiac Arrhythmia Inst, 3000 N IH35,Suite 700, Austin, TX 78705 USA
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