title: Rationale and design of the RT-AF study: Combination of rivaroxaban and ticagrelor in patients with atrial fibrillation and coronary artery disease undergoing percutaneous coronary intervention.
abstract: OBJECTIVE
  Optimal antithrombotic strategy for patients with concomitant coronary artery disease and atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) is still controversial, and the role of novel antithrombotic agents has nerve been tested. Therefore, the aim of this study is to evaluate and overall safety and efficacy profile of the combination of rivaroxaban and ticagrelor in this particular population.
  
  
  METHODS
  The RT-AF study is an open-label, randomized, active-controlled, multicenter clinical trial with up to 420 subjects enrolled in 5 centers. Eligible patients, who have a history or new onset paroxysmal, persistent, or permanent non-valvular AF, referred to the study centers with indications for PCI will be randomly assigned to receive triple therapy (including warfarin, clopidogrel and aspirin) or dual therapy (rivaroxaban and ticagrelor). All subjects will have clinical follow-up at discharge, at 30 days, 6 months and 12 months. The primary end point is major or clinically relevant non-major bleeding events at 12 months. The major secondary end point is the composite efficacy outcome of death, myocardial infarction, stent thrombosis and ischemic stroke.
  
  
  CONCLUSIONS
  The study will be sufficiently powered to provide data primarily regarding the safety of dual therapy with rivaroxaban and ticagrelor over the traditional triple therapy in patients with AF undergoing PCI at 12 months. It will also provide important information regarding the efficacy of the two different antithrombotic regimens. (ClinicalTrials.gov identifier: NCT02334254).
authors.affiliation: Department of Cardiology, An Zhen Hospital, Capital Medical University, Beijing, China.
authors.forename: Fei
authors.initials: F
authors.lastname: Gao
authors.affiliation: Department of Cardiology, An Zhen Hospital, Capital Medical University, Beijing, China.
authors.forename: Hua
authors.initials: H
authors.lastname: Shen
authors.affiliation: Department of Cardiology, An Zhen Hospital, Capital Medical University, Beijing, China.
authors.forename: Zhi Jian
authors.initials: ZJ
authors.lastname: Wang
authors.affiliation: Department of Cardiology, An Zhen Hospital, Capital Medical University, Beijing, China.
authors.forename: Shi Wei
authors.initials: SW
authors.lastname: Yang
authors.affiliation: Department of Cardiology, An Zhen Hospital, Capital Medical University, Beijing, China.
authors.forename: Xiao Li
authors.initials: XL
authors.lastname: Liu
authors.affiliation: Department of Cardiology, An Zhen Hospital, Capital Medical University, Beijing, China. Electronic address: azzyj12@163.com.
authors.forename: Yu Jie
authors.initials: YJ
authors.lastname: Zhou
mesh_terms: D000241:Adenosine / Q000031:analogs & derivatives / Q000627:therapeutic use; D000925:Anticoagulants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001241:Aspirin / Q000627:therapeutic use; D001281:Atrial Fibrillation / Q000188:drug therapy* / Q000453:epidemiology; D000077144:Clopidogrel; D003324:Coronary Artery Disease / Q000453:epidemiology / Q000601:surgery*; D004359:Drug Therapy, Combination; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D012107:Research Design; D000069552:Rivaroxaban / Q000627:therapeutic use; D000077486:Ticagrelor; D013988:Ticlopidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D014859:Warfarin / Q000627:therapeutic use
chemical_list: D000925:Anticoagulants; D014859:Warfarin; D000069552:Rivaroxaban; D000077144:Clopidogrel; D000077486:Ticagrelor; D000241:Adenosine; D013988:Ticlopidine; D001241:Aspirin
keywords: Antithrombotic therapy; Atrial fibrillation; Percutaneous coronary intervention; Rivaroxaban; Ticagrelor