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Atrial FibrillationPhase 4RE-SOUNDNCT03975062

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

A Phase 4 study testing dabigatran etexilate in people with Atrial Fibrillation, run by Ural State Medical University at 1 site in Russia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 19 to 74 years
Conditions the study is for
Atrial Fibrillation
What is being tested?
dabigatran etexilate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteRussia
Study dates
28 Dec 2017to 30 Dec 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 31Show fewer
  • 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 locations and contacts

1 site in 1 country.

Vadim G Grachev, PhD contact

+79193920247 ext. +79193920247

grach_vad@mail.ru

Russia1 site, 1 recruiting

  • Limited Liability Company Medical Association "Novaya Bolnitsa"

    Yekaterinburg, 620109

    Elena G Fokina, +79122474898, fokina@newhospital.ru

    Recruiting

Other trials in Russia

About this 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

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

Read the 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

Being tested
dabigatran etexilate
Keywords
atrial fibrillation, cardioversion, anticoagulation, dabigatran, magnetic resonance imaging
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dabigatran etexilateDrug

    150 mg twice daily (BID)

Study groups in NCT03975062
Study groupRoleWhat they receive
Abbreviated course group (ACG)ExperimentalThe 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
Receives: Drug: dabigatran etexilate
Conventional course group (CCG)Active comparatorThe 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
Receives: Drug: dabigatran etexilate

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 30 days after cardioversion

Secondary outcomes (7)

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

    An acute episode of focal or global neurological dysfunction caused by brain, spinal cord or retinal vascular injury as a result of hemorrhage or infarction (with imaging, pathological or other objective evidence of cerebral, spinal cord or retinal injury or clinical evidence with symptoms persisting ≥24 hours or until death and other etiology excluded) or transient (<24 hours) episode of focal neurological dysfunction caused by brain, spinal cord or retinal ischemia without acute infarction

    Measured: within 30 days after cardioversion

  2. the proportion of patients with major bleeding events after cardioversion

    major bleeding as defined by the International Society of Thrombosis and Hemostasis (ISTH) criteria

    Measured: within 30 days after cardioversion

  3. the proportion of patients with any bleeding events after cardioversion

    any clinical obvious bleeding

    Measured: within 30 days after cardioversion

  4. the proportion of patients with intracranial bleeding events after cardioversion

    symptomatic intraparenchymal, intraventricular, subarachnoid, subdural, epidural hemorrhage with imaging or pathological evidence

    Measured: within 30 days after cardioversion

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

    any clinical obvious bleeding

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

  6. the proportion of patients with at least one major bleeding event since the first dose of dabigatran

    major bleeding as defined by the ISTH criteria

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

  7. the proportion of patients with intracranial bleeding events since the first dose of dabigatran

    symptomatic intraparenchymal, intraventricular, subarachnoid, subdural, epidural hemorrhage with imaging or pathological evidence

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2019
  2. Study start28 Dec 2017
  3. Primary completion30 Dec 2020 (estimated)
  4. Study completion30 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
PROBE design, multicenter, active control trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03975062
Sponsor's protocol ID
1160.242
Acronym
RE-SOUND
Status last verified
Jun 2019
First submitted
28 May 2019
Last updated
5 Jun 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing dabigatran etexilate in people with Atrial Fibrillation, run by Ural State Medical University at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Vadim G Grachev, PhD (+79193920247 ext. +79193920247, grach_vad@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the proportion of patients with new magnetic resonance imaging (MRI) detected cerebral embolic events (time frame: 30 days after cardioversion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03975062.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2019.

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