title: Efficacy and safety of rivaroxaban vs warfarin in high-risk patients with antiphospholipid syndrome: Rationale and design of the Trial on Rivaroxaban in AntiPhospholipid Syndrome (TRAPS) trial.
abstract: BACKGROUND
  New oral anticoagulants may simplify long-term therapy in conditions requiring anticoagulation. Rivaroxaban is a direct factor Xa inhibitor that has been extensively studied and is now approved for the prevention and therapy of a number of thromboembolic conditions.
  
  
  OBJECTIVE
  This is a multicentre, randomized, open-label, study that will evaluate if Rivaroxaban 20 mg od (or 15 mg od in patients with moderate renal insufficiency) is non-inferior to warfarin (INR target 2.5), for the prevention of thromboembolic events, major bleeding and death in high risk (triple positive) patients with antiphospholipid syndrome. Secondary endpoints will assess the incidence of any individual component of the composite end point. An external adjudication committee will evaluate all suspected outcome events. This will be a unique trial, as it will enrol the biggest homogenous cohort of high risk APS individuals.
  
  
  CONCLUSIONS
  The methods and the study design should be appropriate to achieve study results that are both scientifically valid and relevant to clinical practice.
authors.affiliation: Clinical Cardiology, Thrombosis Centre, Department of Cardiac Thoracic and Vascular Sciences, University of Padova School of Medicine, Padova, Italy vittorio.pengo@unipd.it.
authors.forename: V
authors.initials: V
authors.lastname: Pengo
authors.affiliation: Clinical Cardiology, Thrombosis Centre, Department of Cardiac Thoracic and Vascular Sciences, University of Padova School of Medicine, Padova, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Banzato
authors.affiliation: Clinical Cardiology, Thrombosis Centre, Department of Cardiac Thoracic and Vascular Sciences, University of Padova School of Medicine, Padova, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Bison
authors.affiliation: Clinical Cardiology, Thrombosis Centre, Department of Cardiac Thoracic and Vascular Sciences, University of Padova School of Medicine, Padova, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Zoppellaro
authors.affiliation: Clinical Cardiology, Thrombosis Centre, Department of Cardiac Thoracic and Vascular Sciences, University of Padova School of Medicine, Padova, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Padayattil Jose
authors.affiliation: Clinical Cardiology, Thrombosis Centre, Department of Cardiac Thoracic and Vascular Sciences, University of Padova School of Medicine, Padova, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Denas
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D016736:Antiphospholipid Syndrome / Q000097:blood / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D001777:Blood Coagulation / Q000187:drug effects*; D002985:Clinical Protocols; D065427:Factor Xa Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D019934:International Normalized Ratio; D008297:Male; D008875:Middle Aged; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D000069552:Rivaroxaban / Q000009:adverse effects / Q000627:therapeutic use*; D013923:Thromboembolism / Q000097:blood / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D016896:Treatment Outcome; D014859:Warfarin / Q000009:adverse effects / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D000925:Anticoagulants; D065427:Factor Xa Inhibitors; D014859:Warfarin; D000069552:Rivaroxaban
keywords: APS; antiphospholipid; rivaroxaban; syndrome; trial; warfarin