Archives of the Turkish Society of Cardiology
Design and rationale of dabigatran’s stroke prevention in real life in Turkey (D-SPIRIT) [Turk Kardiyol Dern Ars]
Turk Kardiyol Dern Ars. 2016; 44(3): 221-227 | DOI: 10.5543/tkda.2015.37209

Design and rationale of dabigatran’s stroke prevention in real life in Turkey (D-SPIRIT)

Uğur Önsel Türk1, Emin Alioğlu2, Eşref Tunçer2, Mehmet Emre Özpelit3, Nihat Pekel3, İstemihan Tengiz3, Nurullah Çetin4, Onur Dalgıç4, Caner Topaloğlu4, Nazile Bilgin5, Cihan Altın6, Tolga Özdemirkıran7, Kamil Tülüce8, Ebru İpek Türkoğlu9, Ebru Özpelit10
1Ege University Center For Drug Research & Development And Pharmacokinetic Applications, Izmir, Turkey
2Department of Cardiology, Central Hospital, Izmir, Turkey
3Department of Cardiology, İzmir University Faculty of Medicine, Izmir, Turkey
4Department of Cardiology, Karşıyaka State Hospital, Izmir, Turkey
5Department of Cardiology, Menemen State Hospital, Izmir, Turkey
6Department of Cardiology, Baskent University Ankara Hospital, Ankara, Turkey
7Department of Norology, İzmir University Faculty of Medicine, Izmir, Turkey
8Department of Cardiology, Tepecik Training and Research Hospital, Izmir, Turkey
9Department of Cardiology, Kemalpaşa State Hospital, Izmir, Turkey
10Department of Cardiology, Dokuz Eylül University Faculty of Medicine, Izmir, Turkey


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.

CONCLUSION
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.

Keywords: Atrial fibrillation, dabigatran etexilate; prevention; registry stroke; Turkey

How to cite this article
Uğur Önsel Türk, Emin Alioğlu, Eşref Tunçer, Mehmet Emre Özpelit, Nihat Pekel, İstemihan Tengiz, Nurullah Çetin, Onur Dalgıç, Caner Topaloğlu, Nazile Bilgin, Cihan Altın, Tolga Özdemirkıran, Kamil Tülüce, Ebru İpek Türkoğlu, Ebru Özpelit. Design and rationale of dabigatran’s stroke prevention in real life in Turkey (D-SPIRIT). Turk Kardiyol Dern Ars. 2016; 44(3): 221-227

Corresponding Author: Uğur Önsel Türk, Türkiye
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