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

NCT03975062 | Unknown Phase 4

• 1 other identifier: 1160.242
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; cardioversion; anticoagulation; dabigatran; magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• the incidence of symptomatic cerebral thromboembolic events (stroke or TIA)

  within 30 days after cardioversion

• the proportion of patients with major bleeding events after cardioversion

  within 30 days after cardioversion

• the proportion of patients with any bleeding events after cardioversion

  within 30 days after cardioversion

• the proportion of patients with intracranial bleeding events after cardioversion

  within 30 days after cardioversion

• the proportion of patients with at least one bleeding event since the first dose of dabigatran

  from the first dose of dabigatran etexilate till 30th day after cardioversion

Other Outcomes (7)

• rate of sinus rhythm restoration after cardioversion

  within 30 days after cardioversion

• rate of AF recurrence

  from 10 minutes till 30th day after cardioversion

• the time until restoration of left atrial (LA) mechanic function

  during 5 days from cardioversion until peak A revealed or until atrial fibrillation recurrence (if this happens before)

Study Arms (2)

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

Drug: dabigatran etexilate

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

Drug: dabigatran etexilate

Interventions

dabigatran etexilate DRUG

150 mg twice daily (BID)

Abbreviated course group (ACG); Conventional course group (CCG)

Eligibility Criteria

• Age: 19 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ural State Medical University: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

Limited Liability Company Medical Association "Novaya Bolnitsa"

Yekaterinburg, 620109, Russia

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Dabigatran

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Olga G Smolenskaya, MD

  Ural State Medical University

  STUDY CHAIR

• Vadim G Grachev, PhD

  Ural State Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vadim G Grachev, PhD

CONTACT

+79193920247; grach_vad@mail.ru

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded evaluation of primary outcome by Imaging expert, who will made decision regarding achievement of primary outcome
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: PROBE design, multicenter, active control trial

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: June 5, 2019
• Study Start: December 28, 2017
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: June 5, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)