title: 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.
abstract: BACKGROUND
  Dabigatran 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.
  
  
  OBJECTIVE
  The 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.
  
  
  METHODS
  The 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.
  
  
  CONCLUSIONS
  This 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.
authors.affiliation: Interdisciplinary 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.
authors.forename: Marion
authors.identifier: http://orcid.org/0000-0002-9915-707X
authors.initials: M
authors.lastname: Ferner
authors.affiliation: Interdisciplinary Center for Clinical Trials (IZKS) at the University Medical Center of the Johannes Gutenberg-University Mainz, Langenbeckstrasse 1, 55131, Mainz, Germany.
authors.forename: Daniel
authors.initials: D
authors.lastname: Wachtlin
authors.affiliation: 2nd Clinic for Internal Medicine at the University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.
authors.forename: Torsten
authors.initials: T
authors.lastname: Konrad
authors.affiliation: Interdisciplinary Center for Clinical Trials (IZKS) at the University Medical Center of the Johannes Gutenberg-University Mainz, Langenbeckstrasse 1, 55131, Mainz, Germany.
authors.forename: Oliver
authors.initials: O
authors.lastname: Deuster
authors.affiliation: Deutsche Herzstiftung, Frankfurt Am Main, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Meinertz
authors.affiliation: 2nd Clinic for Internal Medicine at the University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.
authors.forename: Stephan
authors.initials: S
authors.lastname: von Bardeleben
authors.affiliation: 2nd Clinic for Internal Medicine at the University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Münzel
authors.affiliation: Interdisciplinary Center for Clinical Trials (IZKS) at the University Medical Center of the Johannes Gutenberg-University Mainz, Langenbeckstrasse 1, 55131, Mainz, Germany.
authors.forename: Monika
authors.initials: M
authors.lastname: Seibert-Grafe
authors.affiliation: Department of Cardiovascular Medicine, University Hospital Münster, Münster, Germany.|Competence Network on Atrial Fibrillation, Münster, Germany.
authors.forename: Günter
authors.initials: G
authors.lastname: Breithardt
authors.affiliation: 2nd Clinic for Internal Medicine at the University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Rostock
mesh_terms: D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use; D000991:Antithrombins / Q000009:adverse effects / Q000627:therapeutic use*; D020517:Atrial Appendage / Q000473:pathology; D001281:Atrial Fibrillation / Q000150:complications / Q000188:drug therapy*; D000069604:Dabigatran / Q000009:adverse effects / Q000627:therapeutic use*; D017548:Echocardiography, Transesophageal / Q000379:methods; D006801:Humans; D010644:Phenprocoumon / Q000009:adverse effects / Q000627:therapeutic use; D011446:Prospective Studies; D012107:Research Design; D013927:Thrombosis / Q000188:drug therapy* / Q000209:etiology
chemical_list: D000925:Anticoagulants; D000991:Antithrombins; D000069604:Dabigatran; D010644:Phenprocoumon
keywords: Anticoagulants; Atrial Appendage Thrombus; Atrial fibrillation; Dabigatran; NOAC; Thrombus Resolution