---
title: Evaluation of Abbreviated Versus Conventional Course of Dabigatran Etexilate Before Electric Cardioversion in Patients With Atrial Fibrillation (RE-SOUND Study)
nct_id: NCT03975062
overall_status: UNKNOWN
phase: PHASE4
sponsor: Ural State Medical University
study_type: INTERVENTIONAL
primary_condition: Atrial Fibrillation
countries: Russia
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03975062.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03975062"
ct_last_update_post_date: 2019-06-05
last_seen_at: "2026-05-12T06:14:23.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Evaluation of Abbreviated Versus Conventional Course of Dabigatran Etexilate Before Electric Cardioversion in Patients With Atrial Fibrillation (RE-SOUND Study)

**Official Title:** "Prospective Open Label Randomized Evaluation of Abbreviated Course of Dabigatran Etexilate With tranSesophageal echOcardiography (TEE) Control vs Conventional 3-week coUrse With dabigatraN Etexilate Before Cardioversion: Analysis of MRI-detecteD Cerebral Embolism" (RE-SOUND Study), № 1160.242

**NCT ID:** [NCT03975062](https://clinicaltrials.gov/study/NCT03975062)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 400
- **Lead Sponsor:** Ural State Medical University
- **Collaborators:** Boehringer Ingelheim
- **Conditions:** Atrial Fibrillation
- **Start Date:** 2017-12-28
- **Completion Date:** 2020-12-30
- **CT.gov Last Update:** 2019-06-05

## 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

## Detailed 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

## Eligibility

- **Minimum age:** 19 Years
- **Maximum age:** 74 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **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

## Interventions

- **dabigatran etexilate** (DRUG) — 150 mg twice daily (BID)

## Primary Outcomes

- **the proportion of patients with new magnetic resonance imaging (MRI) detected cerebral embolic events** _(time frame: 30 days after cardioversion)_ — 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

## Secondary Outcomes

- **the incidence of symptomatic cerebral thromboembolic events (stroke or TIA)** _(time frame: within 30 days after cardioversion)_
- **the proportion of patients with major bleeding events after cardioversion** _(time frame: within 30 days after cardioversion)_
- **the proportion of patients with any bleeding events after cardioversion** _(time frame: within 30 days after cardioversion)_
- **the proportion of patients with intracranial bleeding events after cardioversion** _(time frame: within 30 days after cardioversion)_
- **the proportion of patients with at least one bleeding event since the first dose of dabigatran** _(time frame: 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** _(time frame: 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** _(time frame: from the first dose of dabigatran etexilate till 30th day after cardioversion)_

## Locations (1)

- Limited Liability Company Medical Association "Novaya Bolnitsa", Yekaterinburg, Russia — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.limited liability company medical association "novaya bolnitsa"|yekaterinburg||russia` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT03975062*  
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