Evaluation of Abbreviated Versus Conventional Course of Dabigatran Etexilate Before Electric Cardioversion in Patients With Atrial Fibrillation (RE-SOUND Study)
NCT ID: NCT03975062
Last Updated: 2019-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
400 participants
INTERVENTIONAL
2017-12-28
2020-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Assess Efficacy and Safety of CDR132L in Patients With Reduced Left Ventricular Ejection Fraction After Myocardial Infarction
NCT05350969
Dabigatran Etexilate in Patients With Mechanical Heart Valves
NCT01452347
Exploring the Efficacy of Once Daily Oral Rivaroxaban for Treatment of Thrombus in Left Atrial/Left Atrial Appendage in Subjects With Nonvalvular Atrial Fibrillation or Atrial Flutter
NCT01839357
A Study to Assess the Effectiveness and Safety of Rivaroxaban in Reducing the Risk of Death, Myocardial Infarction or Stroke in Participants With Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure
NCT01877915
Use of Dapagliflozin to Reduce Burden of Atrial Fibrillation in Patients Undergoing Catheter Ablation of Symptomatic Atrial Fibrillation
NCT04792190
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Abbreviated course group (ACG)
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
dabigatran etexilate
150 mg twice daily (BID)
Conventional course group (CCG)
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
dabigatran etexilate
150 mg twice daily (BID)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
dabigatran etexilate
150 mg twice daily (BID)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
19 Years
74 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boehringer Ingelheim
INDUSTRY
Ural State Medical University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Vadim Grachev
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Olga G Smolenskaya, MD
Role: STUDY_CHAIR
Ural State Medical University
Vadim G Grachev, PhD
Role: PRINCIPAL_INVESTIGATOR
Ural State Medical University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Limited Liability Company Medical Association "Novaya Bolnitsa"
Yekaterinburg, , Russia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1160.242
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.