title: Design and rationale of dabigatran's stroke prevention in real life in Turkey (D-SPIRIT).
abstract: OBJECTIVE
  The D-SPIRIT registry is designed to investigate the safety and efficacy of dabigatran etexilate in patients with nonvalvular atrial fibrillation (NVAF) and to collect data on outcomes in clinical practice.
  
  
  METHODS
  The D-SPIRIT is a national, prospective, observational, post-marketing registry involving patients with NVAF who have been taking dabigatran etexilate therapy for stroke prevention for a minimum of 6 months prior to enrollment. The registry will collect and analyze data from routine care, enrolling up to 600 patients in 9 centers. Patients will be followed up for 2 years to evaluate effectiveness and safety. A sample size of 600 subjects is proposed based on the following assumptions; Two-sided significance level of 0.05 (1-sided significance level of 0.025), ischemic stroke incidence rate of 0.768%-1.111%, hemorrhagic stroke incidence rate of 0.109%-0.130%, transient ischemic attack incidence rate of 0.722%-0.623%, therapy discontinuation incidence rate of 40% at day 730, and duration of enrollment period of 12 months with non-uniformed enrollment rate. Ethics approval was given by Dokuz Eylül University Ethics Committee of Clinical Research (2014/54) and approved by the Turkish Ministry of Health.
  
  
  CONCLUSIONS
  Potential results of D-SPIRIT registry will add data from clinical practice to those from the RE-LY trial to expand knowledge of dabigatran etexilate treatment in patients with NVAF.
authors.affiliation: Ege University Center for Drug Research and Development and Pharmacokinetic Applications, İzmir, Turkey. droturk@yahoo.com.
authors.forename: Uğur Önsel
authors.initials: UÖ
authors.lastname: Türk
authors.affiliation: Department of Cardiology, Central Hospital, İzmir, Turkey.
authors.forename: Emin
authors.initials: E
authors.lastname: Alioğlu
authors.affiliation: Department of Cardiology, Central Hospital, İzmir, Turkey.
authors.forename: Eşref
authors.initials: E
authors.lastname: Tunçer
authors.affiliation: Department of Cardiology, İzmir University Faculty of Medicine, İzmir, Turkey.
authors.forename: Mehmet Emre
authors.initials: ME
authors.lastname: Özpelit
authors.affiliation: Department of Cardiology, İzmir University Faculty of Medicine, İzmir, Turkey.
authors.forename: Nihat
authors.initials: N
authors.lastname: Pekel
authors.affiliation: Department of Cardiology, İzmir University Faculty of Medicine, İzmir, Turkey.
authors.forename: İstemihan
authors.initials: İ
authors.lastname: Tengiz
authors.affiliation: Department of Cardiology, Karşıyaka State Hospital, İzmir, Turkey.
authors.forename: Nurullah
authors.initials: N
authors.lastname: Çetin
authors.affiliation: Department of Cardiology, Karşıyaka State Hospital, İzmir, Turkey.
authors.forename: Onur
authors.initials: O
authors.lastname: Dalgıç
authors.affiliation: Department of Cardiology, Karşıyaka State Hospital, İzmir, Turkey.
authors.forename: Caner
authors.initials: C
authors.lastname: Topaloğlu
authors.affiliation: Department of Cardiology, Menemen State Hospital, İzmir, Turkey.
authors.forename: Nazile
authors.initials: N
authors.lastname: Bilgin
authors.affiliation: Department of Cardiology, Başkent University Faculty of Medicine, Ankara, Turkey.
authors.forename: Cihan
authors.initials: C
authors.lastname: Altın
authors.affiliation: Department of Norology, İzmir University Faculty of Medicine, İzmir, Turkey.
authors.forename: Tolga
authors.initials: T
authors.lastname: Özdemirkıran
authors.affiliation: Department of Cardiology, Tepecik Training and Research Hospital, İzmir, Turkey.
authors.forename: Kamil
authors.initials: K
authors.lastname: Tülüce
authors.affiliation: Department of Cardiology, Kemalpaşa State Hospital, İzmir, Turkey.
authors.forename: Ebru İpek
authors.initials: Eİ
authors.lastname: Türkoğlu
authors.affiliation: Department of Cardiology, Dokuz Eylül University Faculty of Medicine, İzmir, Turkey.
authors.forename: Ebru
authors.initials: E
authors.lastname: Özpelit
mesh_terms: D000328:Adult; D000991:Antithrombins / Q000627:therapeutic use*; D000069604:Dabigatran / Q000627:therapeutic use*; D015340:Epidemiologic Research Design; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012042:Registries; D020521:Stroke / Q000188:drug therapy / Q000453:epidemiology / Q000517:prevention & control; D014421:Turkey / Q000453:epidemiology
chemical_list: D000991:Antithrombins; D000069604:Dabigatran