title: Design and rationale of Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation: a global registry program on long-term oral antithrombotic treatment in patients with atrial fibrillation.
abstract: BACKGROUND
  Atrial fibrillation (AF) is the most common cardiac arrhythmia, affecting 1% to 2% of the population and raising the risk of stroke 5-fold. Until recently, the only treatment choices for stroke prevention in patients with AF have been vitamin K antagonists (VKA) or antiplatelet drugs. With approval of novel oral anticoagulants (NOACs) antithrombotic treatment, patterns are changing. The Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation is designed to investigate patient characteristics influencing choice of antithrombotic treatment of stroke prevention in patients with nonvalvular AF and to collect data on outcomes of antithrombotic therapy in clinical practice.
  
  
  METHODS
  The GLORIA-AF is a large, international, observational registry involving patients with newly diagnosed nonvalvular AF at risk for stroke, enrolling up to 56,000 patients in nearly 50 countries. We will collect and analyze data from routine care using an inception cohort design. Phase I includes patients before approval of NOACs. Phase II, beginning early after approval of dabigatran, monitors dabigatran safety and addresses potential channeling across treatment options based on propensity scoring to assess comparability of baseline characteristics of patients treated with dabigatran or VKA. Phase III entails analysis of large treatment groups, adjusting for differences in propensity score, to provide information about the relative effectiveness and safety of NOACs and VKA in routine clinical care.
  
  
  CONCLUSIONS
  Novel features of this registry program will add data from clinical practice to those from randomized trials to expand knowledge of antithrombotic treatment in patients with AF.
authors.affiliation: Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, The Netherlands. Electronic address: M.V.Huisman@lumc.nl.
authors.forename: Menno V
authors.initials: MV
authors.lastname: Huisman
authors.affiliation: University of Birmingham Centre for Cardiovascular Sciences, City Hospital, Birmingham, United Kingdom.
authors.forename: Gregory Y H
authors.initials: GY
authors.lastname: Lip
authors.affiliation: Department of Neurology and Stroke Center, University Hospital Essen, Essen, Germany.
authors.forename: Hans C
authors.initials: HC
authors.lastname: Diener
authors.affiliation: Arrhythmias and Electrophysiology Service, Clinica y Maternidad Suizo Argentina, Buenos Aires, Argentina.
authors.forename: Sergio J
authors.initials: SJ
authors.lastname: Dubner
authors.affiliation: The Cardiovascular Institute, Mount Sinai Medical Center, New York, NY.
authors.forename: Jonathan L
authors.initials: JL
authors.lastname: Halperin
authors.affiliation: Cardiology Department Atrial Fibrillation Center, Beijing An Zhen Hospital, Beijing, China.
authors.forename: Chang S
authors.initials: CS
authors.lastname: Ma
authors.affiliation: RTI Health Solutions, Research Triangle Institute, Research Triangle Park, NC; Department of Epidemiology, Boston University School of Public Health, Boston, MA.
authors.forename: Kenneth J
authors.initials: KJ
authors.lastname: Rothman
authors.affiliation: Corporate Division Medicine, TA Cardiovascular, Boehringer Ingelheim GmbH, Ingelheim, Germany.
authors.forename: Christine
authors.initials: C
authors.lastname: Teutsch
authors.affiliation: Corporate Department Global Epidemiology, Boehringer Ingelheim GmbH, Ingelheim, Germany.
authors.forename: Kristina
authors.initials: K
authors.lastname: Zint
authors.affiliation: Corporate Department Global Epidemiology, Boehringer Ingelheim GmbH, Ingelheim, Germany.
authors.forename: Diana
authors.initials: D
authors.lastname: Ackermann
authors.affiliation: Corporate Division Medicine, TA Cardiovascular, Boehringer Ingelheim GmbH, Ingelheim, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Clemens
authors.affiliation: Corporate Department Global Epidemiology, Boehringer Ingelheim GmbH, Ingelheim, Germany; Hannover Medical School, Hannover, Germany.
authors.forename: Dorothee B
authors.initials: DB
authors.lastname: Bartels
mesh_terms: D000925:Anticoagulants / Q000627:therapeutic use*; D000991:Antithrombins / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000150:complications / Q000188:drug therapy*; D001562:Benzimidazoles / Q000627:therapeutic use; D015331:Cohort Studies; D003430:Cross-Sectional Studies; D000069604:Dabigatran; D005343:Fibrinolytic Agents / Q000627:therapeutic use*; D006801:Humans; D012042:Registries; D020521:Stroke / Q000209:etiology / Q000517:prevention & control*; D016896:Treatment Outcome; D015091:beta-Alanine / Q000031:analogs & derivatives / Q000627:therapeutic use
chemical_list: D000925:Anticoagulants; D000991:Antithrombins; D001562:Benzimidazoles; D005343:Fibrinolytic Agents; D015091:beta-Alanine; D000069604:Dabigatran