evaluation of abbreviated versus conventional course of dabigatran etexilate before electric cardioversion in patients with atrial fibrillation (re-sound study)

Conditions: Atrial Fibrillation

Summary: 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

Eligibility criteria:
inclusion criteria: * male and female subjects aged \>18 years old and \<75 years old * the diagnosis of non-valvular atrial fibrillation/atrial flutter duration of 48 hours or more (or unknown) documented by ecg. duration of af will be defined on the base of patient source documents * documented physician's decision to conduct electrical cardioversion * written informed consent form (icf) signed by patient exclusion criteria: * effective treatment with oral anticoagulants within the last 30 days * need in anticoagulant treatment for disorder other than af * rheumatic heart disease * mitral stenosis of unknown origin * mechanic heart valve * acute coronary syndrome within 12 months * percutaneous coronary intervention (pci) or coronary artery bypass graft (cabg) surgery within the last 12 month or planned for the next 8 weeks * known hypersensitivity for dabigatran, dabigatran etexilate or to any of capsul's components * creatinine clearance \<30 ml/min * active bleeding, haemorrhagic diathesis, coagulopathy * major surgery within the previous month, surgery planned for the next 8 weeks, * clinically relevant bleeding within the last 30 days * symptomatic or endoscopically documented gastroduodenal ulcers within the last 30 days * intracranial haemorrhages in medical history * organ damages resulted from clinically relevant bleeding within 6 months before randomization. * major trauma or any craniocerebral trauma within 30 days before randomization. * any cancer within last 5 years * uncontrolled hypertension (systolic blood pressure \>180mm hg and/or diastolic blood pressure \>100 mmhg). * chronic heart failure (chf) iii-iv functional classes (by nyha) * severe ischemic stroke within the last 12 month before randomization * changes of liver functions with alanine aminotransferase (alt)/aspartate aminotransferase (ast) \>3 upper limit of normal (uln) * liver disease having impact on survival * pregnancy and breast feeding. women of child bearing potential must agree to the requirements for pregnancy testing and contraceptive methods * any contraindications for electric cardioversion (see attachment # 1 for details). * any contraindications to cerebral mri * any contraindications to tee ( perforated viscus; esophageal pathology (stricture, trauma, tumor, scleroderma, mallory-weiss tear, diverticulum); tracheoesophageal fistula; active upper gi bleeding; recent upper gi surgery; esophagectomy, esophagogastrectomy.) * patients who on the discretion of physician will not benefit from 150 bid dose of dabigatran during study course * active hepatitis * anemia (hemoglobin level \<100g/l) or thrombocytopenia (platelet count \<100 × 109/l) * alcohol abuse * hyperthyroidism

Keywords: atrial fibrillation cardioversion anticoagulation dabigatran magnetic resonance imaging