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Prevention of Silent Cerebral Thromboembolism by Oral Anticoagulation With Dabigatran After Pulmonary Vein Isolation for Atrial Fibrillation (ODIn-AF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by University Hospital, Bonn
Boehringer Ingelheim
Information provided by (Responsible Party):
Georg Nickenig, University Hospital, Bonn Identifier:
First received: February 18, 2014
Last updated: October 26, 2016
Last verified: October 2016
Oral anticoagulation treatment (OAC) following clinically successful catheter abla-tion of atrial fibrillation (AF) is controversial. Recent guidelines recommended con-tinuation of OAC in all patients with CHA2DS2VASc score ≥2 even if there is no evidence of recurrent AF (Camm JA et al., Eur Heart J 2012). The net clinical ben-efit of OAC after successful ablation in these patients remains to some extent un-clear. As OAC bears the risk of bleeding events, the ODIn-AF study aims to evalu-ate the positive effect of OAC on the incidence of silent cerebral embolic events in patients with a high risk for embolic events, free from AF after successful pulmo-nary vein ablation. ODIn-AF aims to determine that continued administration of dabigatran is superior in the preven-tion of silent cerebral embolism to discontinuation of OAC after 3 months in pa-tients free from symptomatic AF-episodes with a CHA2DS2VASc score ≥2 after the first pulmonary vein ablation for paroxysmal AF.

Condition Intervention Phase
Atrial Fibrillation
Cardioembolic Events
Oral Anticoagulation
Drug: Dabigatran
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prevention of Silent Cerebral Thromboembolism by Oral Anticoagulation With Dabigatran After Pulmonary Vein Isolation for Atrial Fibrillation

Resource links provided by NLM:

Further study details as provided by University Hospital, Bonn:

Primary Outcome Measures:
  • Incidence of new micro- and macro-embolic lesions on cerebral MRI incl. flare and diffusion weighted imaging 12 months after randomization compared to baseline MRI (3 months after AF catheter ablation) [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Location, size and number of new micro- and macro-embolic lesions on cerebral MRI [ Time Frame: 12 months ]
  • Incidence of clinically evident cardio-embolic events (stroke, TIA, systemic embolism) [ Time Frame: 12 months ]
  • Severity of neurological deficits assessed by Modified Rankin Scale [ Time Frame: 12 months ]
  • Incidence of other thrombotic or thrombo-embolic events (myocardial in-farction, deep vein thrombosis, pulmonary embolism) [ Time Frame: 12 months ]
  • Life-threatening / major / minor bleedings [ Time Frame: 12 months ]
  • Hemorrhagic cerebral infarction [ Time Frame: 12 months ]
  • All-cause mortality / Cardiovascular mortality [ Time Frame: 12 months ]
  • Correlation of cardio-embolic events to method used for PVI (cryo-balloon versus RF) [ Time Frame: 12 months ]
  • Correlation of cardio-embolic events with arrhythmia recurrence (atrial fi-brillation or atrial flutter post ablationem with ECG documentation or symp-toms) [ Time Frame: 12 months ]
  • Quality of life questionnaire (AF-specific symptoms, SF36) [ Time Frame: 12 months ]
  • Neuropsychological questionnaire (RBANS A&B) [ Time Frame: 12 months ]
  • Assessment of neurocognitive deficits: Minimental Test [ Time Frame: 12 months ]

Other Outcome Measures:
  • Major / minor bleeding events [ Time Frame: 12 months ]
  • Clinically evident cardio-embolic events [ Time Frame: 12 months ]
  • Serious Adverse Events [ Time Frame: 12 months ]

Estimated Enrollment: 630
Study Start Date: August 2015
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oral Anticoagulation with Dabigatran

The recommended daily dose of Pradaxa is 300 mg taken as one 150 mg capsule twice daily.

For the following patients the recommended daily dose of Pradaxa is 220 mg taken as one 110 mg capsule twice daily:

  • Patients aged 75 years or above
  • Cr-Cl 30-50 ml/min
  • Patients who receive concomitant verapamil

For the following groups, the daily dose of Pradaxa of 300 mg or 220 mg should be selected based on an individual assessment of the thromboembolic risk and the risk of bleeding:

  • Patients with moderate renal impairment
  • Patients with gastritis, esophagitis or gastroesophageal reflux
  • Other patients at increased risk of bleeding
Drug: Dabigatran
  • Antral pulmonary vein ablation for patients with AF
  • left atrial fibrosis/electrical scar assessment by electroanatomical mapping
  • followed by 6 months OAC (3 months blanking period + 3 months observation period)
  • in case of AF-recurrence in month 4-6: re- pulmonary vein ablation
  • followed again by 6 months OAC (3 months blanking period + 3 months observation period)

AF-free patients as assessed by 72h Holter ECG and symptoms wil be random-izedals to the following two interventional arms:

  • Experimental arm (group A): OAC with dabigatran for 12 months
  • Control arm (group B): No OAC (no placebo medication) for 12 months - Cerebral MRI at randomisation and 12 months later
No Intervention: No Oral Anticoagulation


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Written informed consent
  • Patients scheduled for circumferential antral PV ablation for non-valvular (mitral regurgitation less than moderate- severe; no relevant mitral steno-sis with a mean pressure gradient >5mmHg) symptomatic, paroxysmal AF or persistent AF (duration < 12 months) using a cooled tip RF- or cryobal-loon-catheter
  • CHA2DS2VASc score ≥ 2

Randomization criteria:

  • Sinus rhythm after AF ablation (as assessed by 72h Holter ECG) following the 3 months blanking period
  • No clinical evidence of recurrent AF after completing 3 months blanking period as assessed by symptoms

Exclusion Criteria:

  • Lack of written informed consent
  • Severe mental disorder, drug or alcohol addiction (> 8 drinks/week)
  • Pregnancy/breast feeding
  • Severely impaired renal function, GFR < 30 ml/min
  • Impaired liver function (ALT/AST transaminase count 3fold higher than normal values)
  • Age > 80 years
  • Valvular (less than moderate- severe; no relevant mitral stenosis with a mean pressure gradient >5mmHg) AF
  • Long standing persistent (>12 months) and permanent AF
  • NSTEMI/STEMI/implantated drug eluting stent with indication for dual an-tiplatelet therapy within 12 months before enrolment
  • History of any left atrial ablation procedure
  • Clinical indication for extended left atrial ablation procedures (lines, CFAE-, rotorablation)
  • History or presence of left atrial or ventricular thrombus
  • History of cardioembolic stroke / TIA
  • History of major bleeding or predisposition to bleeding incidences
  • Cerebral lesions or clinical situations of other organ systems with a high risk of severe bleeding
  • History of previous surgery with contraindication for OAC
  • History of malignoma with contraindication for OAC
  • Significant carotid stenosis
  • Mechanical prosthetic heart valve or other indication for permanent OAC
  • Contraindication for MRI
  • Hypersensitivity against dabigatran or other ingredients of the medicinal product
  • Concomitant use of another OAC or heparines
  • Concomitant medication with dronedarone, ketoconazole, itraconazole, cyclosporine, tacrolimus or other interacting drugs as specified in the drug information
  • Simultaneous participation in any clinical trial involving administration of an investigational medicinal product within 30 days prior to clinical trial beginning
  • Females of childbearing potential, who are not using or not willing to use medically reliable methods of contraception for the entire study duration (such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices) unless they are surgically sterilized / hysterecto-mized or there are any other criteria considered sufficiently reliable by the investigator in individual cases
  • Conditions which interfere with the study treatment at the discretion of the investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02067182

Contact: Georg Nickenig, Prof. +49-228-287-15217
Contact: Jan W Schrickel, Prof. +49-228-287-15217

Heart Center Freiburg University Bad Krozingen Recruiting
Bad Krozingen, Germany, 79189
Contact: Arentz Thomas, MD         
Contact: Jüergen Allgeier         
Heart Center Bad Neustadt-Saale Not yet recruiting
Bad Neustadt-Saale, Germany, 97616
Contact: Thomas Deneke, MD         
Dept. of Medicine-Cardiology University Clinic Bonn Recruiting
Bonn, Germany, D-53105
Contact: Jan W Schrickel, Prof.    +49-228-287-15217   
Principal Investigator: Georg Nickenig, Prof.         
Sub-Investigator: Jan W Schrickel, Prof.         
Sub-Investigator: Markus Linhart, Dr.         
Sub-Investigator: Rene Andrié, Ass.-Prof.         
CCB Markus Hospital Recruiting
Frankfurt/Main, Germany, D-60431
Contact: Jongi Chun, MD, PD Dr.    +49-69-945028-110      
University Hospital Gießen Recruiting
Gießen, Germany, 35392
Contact: Jörn Schmitt, MD         
Contact: Thomas Neumann, MD         
Sub-Investigator: Christian Hamm, MD         
Hannover Medical School Not yet recruiting
Hannover, Germany, 30625
Contact: Christian Veltmann, MD         
Contact: Johann Bauersachs, MD         
Westpfalz-Clinic GmbH Kaiserslautern Not yet recruiting
Kaiserslautern, Germany, 67655
Contact: Burghard Schumacher, MD         
Municipal Clinical Center Karlsruhe Not yet recruiting
Karlsruhe, Germany, 76133
Contact: Armin Luik, MD         
Contact: Claus Schmitt, MD         
Heart Center Leipzig Recruiting
Leipzig, Germany, 04289
Contact: Gerhard Hindricks, MD         
Universtity Hosptial Lübeck Recruiting
Lübeck, Germany, 23538
Contact: Frank Bode, MD         
Contact: Holger Thiele, MD         
Hospital Lüdenscheid Not yet recruiting
Lüdenscheid, Germany, 58515
Contact: Markus Zarske, MD         
Contact: Bernd Lemke, MD         
University Hospital Mannheim Not yet recruiting
Mannheim, Germany, 68167
Contact: Boris Rudic, MD         
University Hospital Rostock Not yet recruiting
Rostock, Germany, 18057
Contact: Dietmar Bänsch, MD         
University Hospital Tübingen Not yet recruiting
Tübingen, Germany, 72076
Contact: Jürgen Schreieck, MD         
Contact: Tobias Geisler, MD         
Schwarzwald-Baar Hospital Villingen Schwenningen Recruiting
Villingen Schwenningen, Germany, 78050
Contact: Werner Jung, MD         
Contact: Udo Meyerfeldt, MD         
Sponsors and Collaborators
Georg Nickenig
Boehringer Ingelheim
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Georg Nickenig, Prof., University Hospital, Bonn Identifier: NCT02067182     History of Changes
Other Study ID Numbers: MED2-201301
2013-003492-35 ( EudraCT Number )
Study First Received: February 18, 2014
Last Updated: October 26, 2016

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants processed this record on April 28, 2017