Atrial Fibrillation Clinical Trial
Official title:
"Prospective Open Label Randomized Evaluation of Abbreviated Course of Dabigatran Etexilate With tranSesophageal echOcardiography (TEE) Control vs Conventional 3-week coUrse With dabigatraN Etexilate Before Cardioversion: Analysis of MRI-detecteD Cerebral Embolism" (RE-SOUND Study), № 1160.242
The purpose of the study is to evaluate the efficacy of abbreviated 3-day anticoagulation with dabigatran etexilate before cardioversion guided by trans-oesophageal echocardiography in comparison with conventional 3- week course of dabigatran etexilate before cardioversion
Current guidelines recommend for stroke prevention in patients with atrial fibrillation (AF)
lasting more than 48 h designated for cardioversion standard approach with anticoagulation
for a minimum 3 weeks before anticoagulation. The alternative is abbreviated anticoagulation
in case of using trans-oesophageal echocardiography (TEE)-guided approach with quick
cardioversion if no thrombus or high-grade spontaneous echo contrast is seen. There is
currently no data on the direct comparison of efficacy and safety of conventional and
abbreviated courses of non-vitamin K antagonist oral anticoagulants (NOAC) before
cardioversion in AF.
The RE-SOUND study is prospective open label study with blinded outcome evaluation (PROBE
design) multicenter active control trial comparing efficacy of 3-day abbreviated TEE-guided
and conventional 3-week courses of NOAC dabigatran etexilate before cardioversion in adult
patients with AF lasting more than 48 h
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