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

• Status: Unknown status
• Trial end date: 2020-12-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ural Medical University; Ural State Medical University
• Collaborator: Boehringer Ingelheim
• Treatments: Dabigatran

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