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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
400
150 mg twice daily (BID)
Limited Liability Company Medical Association "Novaya Bolnitsa"
Yekaterinburg, Russia
RECRUITINGthe proportion of patients with new magnetic resonance imaging (MRI) detected cerebral embolic events
patients with new (not visible at pre-cardioversion MRI) cerebral ischemic lesions revealed at MRI after cardioversion and without a history of acute neurological dysfunction attributable to the lesion or with symptomatic cerebral ischemic stroke after cardioversion confirmed by MRI examination
Time frame: 30 days after cardioversion
the incidence of symptomatic cerebral thromboembolic events (stroke or TIA)
An acute episode of focal or global neurological dysfunction caused by brain, spinal cord or retinal vascular injury as a result of hemorrhage or infarction (with imaging, pathological or other objective evidence of cerebral, spinal cord or retinal injury or clinical evidence with symptoms persisting ≥24 hours or until death and other etiology excluded) or transient (\<24 hours) episode of focal neurological dysfunction caused by brain, spinal cord or retinal ischemia without acute infarction
Time frame: within 30 days after cardioversion
the proportion of patients with major bleeding events after cardioversion
major bleeding as defined by the International Society of Thrombosis and Hemostasis (ISTH) criteria
Time frame: within 30 days after cardioversion
the proportion of patients with any bleeding events after cardioversion
any clinical obvious bleeding
Time frame: within 30 days after cardioversion
the proportion of patients with intracranial bleeding events after cardioversion
symptomatic intraparenchymal, intraventricular, subarachnoid, subdural, epidural hemorrhage with imaging or pathological evidence
Time frame: within 30 days after cardioversion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
the proportion of patients with at least one bleeding event since the first dose of dabigatran
any clinical obvious bleeding
Time frame: from the first dose of dabigatran etexilate till 30th day after cardioversion
the proportion of patients with at least one major bleeding event since the first dose of dabigatran
major bleeding as defined by the ISTH criteria
Time frame: from the first dose of dabigatran etexilate till 30th day after cardioversion
the proportion of patients with intracranial bleeding events since the first dose of dabigatran
symptomatic intraparenchymal, intraventricular, subarachnoid, subdural, epidural hemorrhage with imaging or pathological evidence
Time frame: from the first dose of dabigatran etexilate till 30th day after cardioversion