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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abbreviated course group (ACG) | Experimental | The patients receiving 3-days course of dabigatran etexilate during pre-cardioversion period. After cardioversion has been performed the patients continue with dabigatran etexilate until 30 days after cardioversion |
|
| Conventional course group (CCG) | Active Comparator | The patients receiving 3-weeks course of dabigatran etexilate before cardioversion of AF. After cardioversion has been performed the patients will continue with dabigatran etexilate until 30 days after cardioversion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dabigatran etexilate | Drug | 150 mg twice daily (BID) |
|
| Measure | Description | Time Frame |
|---|---|---|
| the 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 | 30 days after cardioversion |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| rate of sinus rhythm restoration after cardioversion | achieving and maintaining of sinus rhythm for at least 10 min after shock | within 30 days after cardioversion |
| rate of AF recurrence | recurrent episodes of AF or atrial flutter |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vadim G Grachev, PhD | Contact | +79193920247 | +79193920247 | grach_vad@mail.ru |
| Name | Affiliation | Role |
|---|---|---|
| Olga G Smolenskaya, MD | Ural State Medical University | Study Chair |
| Vadim G Grachev, PhD | Ural State Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Limited Liability Company Medical Association "Novaya Bolnitsa" | Recruiting | Yekaterinburg | 620109 | Russia |
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PROBE design, multicenter, active control trial
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Blinded evaluation of primary outcome by Imaging expert, who will made decision regarding achievement of primary outcome
| 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 | within 30 days after cardioversion |
| the proportion of patients with any bleeding events after cardioversion | any clinical obvious bleeding | 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 | within 30 days after cardioversion |
| the proportion of patients with at least one bleeding event since the first dose of dabigatran | any clinical obvious bleeding | 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 | 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 | from the first dose of dabigatran etexilate till 30th day after cardioversion |
| from 10 minutes till 30th day after cardioversion |
| the time until restoration of left atrial (LA) mechanic function | transmitral flow peak A restoration on results of echocardiography | during 5 days from cardioversion until peak A revealed or until atrial fibrillation recurrence (if this happens before) |
| D-dimer concentration | D-dimer concentration in laboratory evaluation in sub-set of 100 patients only at one pre-selected investigational site | at the time of cardioversion, 1 day after cardioversion and 10 days after cardioversion |
| brain natriuretic peptide (BNP) level | BNP level in laboratory evaluation in sub-set of 100 patients only at one pre-selected investigational site | right before cardioversion |
| E/E' ratio | the ratio of transmitral Doppler early filling velocity to tissue Doppler early diastolic mitral annular velocity on results of echocardiography | before cardioversion |
| flow velocity in the left atrial appendage (LAA) | flow velocity in the LAA TEE evaluation | precardioversion day |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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