title: Rationale and design of the SAFE-A study: SAFety and Effectiveness trial of Apixaban use in association with dual antiplatelet therapy in patients with atrial fibrillation undergoing percutaneous coronary intervention.
abstract: Patients with atrial fibrillation who undergo coronary stenting require triple antithrombotic therapy, including aspirin, a P2Y12inhibitor, and anticoagulation, to prevent both stroke and stent thrombosis. However, triple therapy may increase the risk of bleeding complications. The optimal management of triple therapy still presents a challenge in these patients.
  
  
  
  We hypothesized that 1-month P2Y12inhibitor treatment after drug-eluting stent (DES) implantation, as compared with 6-month P2Y12inhibitor treatment, in combination with aspirin and apixaban, would be associated with a decrease in the incidence of bleeding complications in patients with atrial fibrillation who undergo DES implantation.
  
  
  
  SAFE-A (UMIN Clinical Trials Registry Number: UMIN000015923) is a multicenter, prospective, randomized, open-label, blinded-endpoint, parallel-group, comparative study that was designed to compare the safety and efficacy of short-duration treatment with a P2Y12inhibitor in combination with aspirin and apixaban in subjects with non-valvular atrial fibrillation who undergo DES implantation. A total of 600 subjects will be randomized in a 1:1 fashion to either 1-month or 6-month P2Y12inhibitor therapy in combination with aspirin and apixaban. The primary endpoint is the incidence of all bleeding complications occurring within 12 months.
  
  
  
  The SAFE-A study is the first randomized controlled trial to compare 1-month vs. 6-month P2Y12inhibitor therapy in combination with aspirin and apixaban, in patients with atrial fibrillation who undergo DES implantation. This study will provide data that may guide the optimal management of triple antithrombotic therapy.
authors.affiliation: Cardiovascular Division, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan. Electronic address: hoshi.tm@md.tsukuba.ac.jp.
authors.forename: Tomoya
authors.initials: T
authors.lastname: Hoshi
authors.affiliation: Cardiovascular Division, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Sato
authors.affiliation: Cardiovascular Division, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan.
authors.forename: Akihiko
authors.initials: A
authors.lastname: Nogami
authors.affiliation: Department of Clinical Trial and Clinical Epidemiology, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan.
authors.forename: Masahiko
authors.initials: M
authors.lastname: Gosho
authors.affiliation: Cardiovascular Division, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan.
authors.forename: Kazutaka
authors.initials: K
authors.lastname: Aonuma
mesh_terms: D001241:Aspirin / Q000008:administration & dosage; D001281:Atrial Fibrillation / Q000150:complications / Q000628:therapy*; D001803:Blood Transfusion; D000077144:Clopidogrel; D004359:Drug Therapy, Combination; D054855:Drug-Eluting Stents; D065427:Factor Xa Inhibitors / Q000008:administration & dosage*; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced / Q000517:prevention & control; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction; D062645:Percutaneous Coronary Intervention; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage; D000068799:Prasugrel Hydrochloride / Q000008:administration & dosage; D011446:Prospective Studies; D058921:Purinergic P2Y Receptor Antagonists / Q000008:administration & dosage*; D011720:Pyrazoles / Q000008:administration & dosage*; D011728:Pyridones / Q000008:administration & dosage*; D020521:Stroke / Q000517:prevention & control; D013988:Ticlopidine / Q000008:administration & dosage / Q000031:analogs & derivatives
chemical_list: D065427:Factor Xa Inhibitors; D010975:Platelet Aggregation Inhibitors; D058921:Purinergic P2Y Receptor Antagonists; D011720:Pyrazoles; D011728:Pyridones; C522181:apixaban; D000077144:Clopidogrel; D000068799:Prasugrel Hydrochloride; D013988:Ticlopidine; D001241:Aspirin
keywords: Apixaban; Atrial fibrillation; Drug-eluting stent; Triple therapy