Evidence map›Paper›PMID 26109251›Full record

Trial reportClinical research in cardiology : official journal of the German Cardiac Society2016

Rationale and design of the RE-LATED AF--AFNET 7 trial: REsolution of Left atrial-Appendage Thrombus--Effects of Dabigatran in patients with Atrial Fibrillation.

Marion Ferner, Daniel Wachtlin, Torsten Konrad, Oliver Deuster, Thomas Meinertz, Stephan von Bardeleben, Thomas Münzel, Monika Seibert-Grafe, Günter Breithardt, Thomas Rostock

Abstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical research in cardiology : official journal of the German Cardiac Society, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 4 pooled it
3.4field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 4 syntheses or guidelines pooled it, 40 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 3 institutions in 1 country.

Marion FernerInterdisciplinary Center for Clinical Trials (IZKS) at the University Medical Center of the Johannes Gutenberg-University Mainz, Langenbeckstrasse 1, 55131, Mainz, Germany. marion.ferner@unimedizin-mainz.de.ORCID http://orcid.org/0000-0002-9915-707X
Daniel WachtlinInterdisciplinary Center for Clinical Trials (IZKS) at the University Medical Center of the Johannes Gutenberg-University Mainz, Langenbeckstrasse 1, 55131, Mainz, Germany.
Torsten Konrad2nd Clinic for Internal Medicine at the University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.
Oliver DeusterInterdisciplinary Center for Clinical Trials (IZKS) at the University Medical Center of the Johannes Gutenberg-University Mainz, Langenbeckstrasse 1, 55131, Mainz, Germany.
Thomas MeinertzDeutsche Herzstiftung, Frankfurt Am Main, Germany.
Stephan von Bardeleben2nd Clinic for Internal Medicine at the University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.
Thomas Münzel2nd Clinic for Internal Medicine at the University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.
Monika Seibert-GrafeInterdisciplinary Center for Clinical Trials (IZKS) at the University Medical Center of the Johannes Gutenberg-University Mainz, Langenbeckstrasse 1, 55131, Mainz, Germany.
Günter BreithardtDepartment of Cardiovascular Medicine, University Hospital Münster, Münster, Germany.
Thomas Rostock2nd Clinic for Internal Medicine at the University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.
Johannes Gutenberg University Mainz · DEDeutsche Herzstiftung · DEUniversity Hospital Münster · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDabigatran etexilate, a direct thrombin inhibitor and non-vitamin K antagonist oral anticoagulant (NOAC), has been shown to effectively prevent thromboembolic events in patients with non-valvular atrial fibrillation (AF). However, there is a paucity of data on the antithrombotic efficacy and safety of dabigatran in the resolution of left atrial appendage (LAA) thrombi in AF patients.

objectiveThe primary objective of the RE-LATED AF trial is to assess whether dabigatran results in a faster complete LAA thrombus resolution as compared to vitamin K antagonist phenprocoumon. Secondary objectives are to assess the impact of dabigatran on complete LAA thrombus resolution rate within 6 weeks of treatment and change in LAA thrombus volume under treatment. Furthermore, this study aims to assess and compare safety and tolerability of dabigatran vs. phenprocoumon.

methodsThe study is designed as a prospective, randomized, open-label, controlled, explorative, blinded endpoint (PROBE) trial. Patients with AF and left atrial appendage thrombus confirmed by transoesophageal echocardiography (TEE) will be randomized to receive either dabigatran (150 mg bid) or phenprocoumon (INR 2-3) for the resolution of LAA thrombus formation for at least 21 days. Thrombus resolution will be determined by TEE 3 weeks after treatment initiation and subsequently at weeks 4 and 6, if the LAA thrombus has not been resolved before. A total of 110 patients are planned to be randomized.

conclusionThis is the first prospective, multicentre, randomized controlled clinical trial investigating safety and efficacy of a NOAC for the resolution of LAA thrombi in patients with non-valvular AF.

Indexed as

AnticoagulantsAntithrombinsAtrial AppendageAtrial FibrillationDabigatranEchocardiography, TransesophagealHumansPhenprocoumonProspective StudiesResearch DesignThrombosisAnticoagulantsAntithrombinsDabigatranPhenprocoumonAnticoagulantsAtrial Appendage ThrombusAtrial fibrillationDabigatranNOACThrombus Resolution

Identifiers

PMID26109251
OpenAlexW1903187438

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.