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

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dc.contributor.authorTurk, Ugur Onsel
dc.contributor.authorAlioglu, Emin
dc.contributor.authorTuncer, Esref
dc.contributor.authorOzpelit, Mehmet Emre
dc.contributor.authorPekel, Nihat
dc.contributor.authorTengiz, Istemihan
dc.contributor.authorCetin, Nurullah
dc.contributor.authorDalgic, Onur
dc.contributor.authorTopaloglu, Caner
dc.contributor.authorBilgin, Nazile
dc.contributor.authorAltin, Cihan
dc.contributor.authorOzdemirkiran, Tolga
dc.contributor.authorTuluce, Kamil
dc.contributor.authorTurkoglu, Ebru Ipek
dc.contributor.authorOzpelit, Ebru
dc.date.accessioned2019-10-27T23:10:33Z
dc.date.available2019-10-27T23:10:33Z
dc.date.issued2016
dc.departmentEge Üniversitesien_US
dc.description.abstractObjective: 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 Eyll 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.en_US
dc.identifier.doi10.5543/tkda.2015.37209en_US
dc.identifier.endpage227en_US
dc.identifier.issn1016-5169
dc.identifier.issue3en_US
dc.identifier.pmid27138311en_US
dc.identifier.scopusqualityQ4en_US
dc.identifier.startpage221en_US
dc.identifier.urihttps://doi.org/10.5543/tkda.2015.37209
dc.identifier.urihttps://hdl.handle.net/11454/52916
dc.identifier.volume44en_US
dc.identifier.wosWOS:000375095000006en_US
dc.identifier.wosqualityN/Aen_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherTurkish Soc Cardiologyen_US
dc.relation.ispartofTurk Kardiyoloji Dernegi Arsivi-Archives of the Turkish Society of Cardiologyen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectAtrial fibrillationen_US
dc.subjectdabigatran etexilateen_US
dc.subjectpreventionen_US
dc.subjectregistry strokeen_US
dc.subjectTurkeyen_US
dc.titleDesign and rationale of dabigatran's stroke prevention in real life in Turkey (D-SPIRIT)en_US
dc.typeArticleen_US

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