Evaluation of Abbreviated Versus Conventional Course of Dabigatran Etexilate Before Electric Cardioversion in Patients With Atrial Fibrillation (RE-SOUND Study)

Ural State Medical University

Status and phase: Unknown; Phase 4

Conditions: Atrial Fibrillation

Treatments: Drug: dabigatran etexilate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03975062

1160.242

Details and patient eligibility

About

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

Full description

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

Enrollment: 400 estimated patients

Sex: All

Ages: 19 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

Abbreviated course group (ACG)

Experimental group

Description:

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

Treatment:

Drug: dabigatran etexilate

Conventional course group (CCG)

Active Comparator group

Description:

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

Treatment:

Drug: dabigatran etexilate