| There are no published study in humans evaluating the efficacy and safety of dabigatran or any other NOACs in patients with mitral and/or aortic bioprosthesis valve. |
| DAWA is a phase 2, prospective, open-label, randomized, pilot study. The main variable to be observed in this study is intracardiac thrombus. There are no formal primary or secondary clinical efficacy or safety outcomes because it is a pilot study. |
| The DAWA study encourages a larger multicentric prospective study to assess the use of new oral anticoagulants in patients with bioprosthesis valve. |
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