1. Protocol, rationale and design of DAbigatran for Stroke PreVention In Atrial Fibrillation in MoDerate or Severe Mitral Stenosis (DAVID-MS): a randomised, open-label study
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Andrew Ng, Esther W Chan, Duo Huang, Cheung Chi Lam, Ning Tan, Chung Wah Siu, Jo Jo Hai, Ji-yan Chen, Chun Ka Wong, Mi Zhou, Yuk Ming LAU, Chor Cheung Frankie Tam, Yiu Tung Anthony Wong, See Yue Arthur Yung, Ki Wan Kelvin Chan, Yingqing Feng, Chi Yui Yung, Kwok Lun Lee, Chun Wai Choi, Ho Lam, Katherine Fan, Man Hong Jim, Kai Hang Yiu, and Bryan P. Yan
- Subjects
Medicine - Abstract
Introduction Current international guidelines recommend non-vitamin K oral anticoagulants (NOACs) for stroke prevention among patients with non-valvular atrial fibrillation (AF) at significant ischaemic stroke risk given the superior safety and comparable efficacy of NOACs over warfarin. Nonetheless, the safety and effectiveness of NOACs have not been evaluated in patients with AF with underlying moderate or severe mitral stenosis (MS), hence the recommended stroke prevention strategy remains warfarin therapy.Method and analysis MS remains disproportionately prevalent in Asian countries compared with the developed countries. This prospective, randomised, open-label trial with blinded endpoint adjudication aims to evaluate the safety and efficacy of dabigatran for stroke prevention in AF patients with moderate or severe MS. Patients with AF aged ≥18 years with moderate or severe MS not planned for valvular intervention in the coming 12 months will be randomised in a 1:1 ratio to receive dabigatran 110 mg or 150 mg two times per day or warfarin with international normalised ratio 2–3 in an open-label design. Patients with estimated creatinine clearance
- Published
- 2020
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