Rationale and Design of Dabigatran for Mitral Stenosis Atrial Fibrillation Trial
Atrial fibrillation (AF) is the most common sustained cardiac arrythmia encountered in clinical practice and patients suffer from this are at increased risk of ischemic stroke and systemic thromboembolism due to the formation and embolism of left atrial thrombi. Current international guidelines recommend non-vitamin K oral anticoagulants (NOACs) for stroke prevention amongst these patients with non-valvular atrial fibrillation (AF) at significant ischemic stroke risk, given the superior safety and comparable efficacy of NOACs over warfarin. However, the safety and efficacy of NOACs had not been evaluated in AF patients with underlying mitral stenosis (MS) thereby the currently recommended stroke prevention strategy remains warfarin therapy for AF patients with underlying MS. A local study is initiated to compare efficacy and safety of Dabigatran with Warfarin therapy in AF patients with moderate to severe MS.
• Patients with atrial fibrillation documented with standard 12-lead ECG documented atrial fibrillation on the day of screening or randomization
• Patients with age ≥ 18 years
• Patients with moderate or severe mitral stenosis, i.e. mitral valvular area (MVA) ≤ 2.5cm2
• Patients should be able to provide a written informed consent
• Patients should have all 4 inclusion-criteria fulfilled to be qualified for the study