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Trial record 45 of 335 for:    DABIGATRAN

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02067182
Recruitment Status : Recruiting
First Posted : February 20, 2014
Last Update Posted : September 3, 2018
Boehringer Ingelheim
Information provided by (Responsible Party):
Georg Nickenig, University Hospital, Bonn

Brief Summary:
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 or disease Intervention/treatment Phase
Atrial Fibrillation Cardioembolic Events Oral Anticoagulation Drug: Dabigatran Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 630 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prevention of Silent Cerebral Thromboembolism by Oral Anticoagulation With Dabigatran After Pulmonary Vein Isolation for Atrial Fibrillation
Study Start Date : August 2015
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Location, size and number of new micro- and macro-embolic lesions on cerebral MRI [ Time Frame: 12 months ]
  2. Incidence of clinically evident cardio-embolic events (stroke, TIA, systemic embolism) [ Time Frame: 12 months ]
  3. Severity of neurological deficits assessed by Modified Rankin Scale [ Time Frame: 12 months ]
  4. Incidence of other thrombotic or thrombo-embolic events (myocardial in-farction, deep vein thrombosis, pulmonary embolism) [ Time Frame: 12 months ]
  5. Life-threatening / major / minor bleedings [ Time Frame: 12 months ]
  6. Hemorrhagic cerebral infarction [ Time Frame: 12 months ]
  7. All-cause mortality / Cardiovascular mortality [ Time Frame: 12 months ]
  8. Correlation of cardio-embolic events to method used for PVI (cryo-balloon versus RF) [ Time Frame: 12 months ]
  9. 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 ]
  10. Quality of life questionnaire (AF-specific symptoms, SF36) [ Time Frame: 12 months ]
  11. Neuropsychological questionnaire (RBANS A&B) [ Time Frame: 12 months ]
  12. Assessment of neurocognitive deficits: Minimental Test [ Time Frame: 12 months ]

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

Information from the National Library of Medicine

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

Inclusion criteria:

  1. Written informed consent
  2. Patients undergoing circumferential antral PV ablation for non-valvular (mitral regurgitation less than moderate- severe insufficiency; no relevant mitral stenosis with a mean pressure gradient >5mmHg) symptomatic, paroxysmal AF or persistent AF (duration < 12 months) with risk factors resulting in a CHA2DS2VASc score ≥2, using a cooled tip RF-, laser- or cryo-balloon-catheter.
  3. CHA2DS2VASc score ≥2

Randomization criteria:

  1. Sinus rhythm (as assessed by 72h Holter ECG) following the 3 months blanking and 3 months observation period after first or second pulmo-nary vein ablation procedure
  2. No clinical evidence of recurrent AF after completing 3 months blanking and 3 months observation period as assessed by symptoms
  3. No other relevant contraindication for OAC assessed by randomization MRI of the brain

Exclusion criteria:

  1. Severe mental retardation or psychiatrical disorder resulting in incapabil-ity to adequately understand nature, significance, implications and risks of study parcipitation (i.e. bipolar disorders, severe depression, suicidal tendencies, among others) as judged by the local physician, ongoing drug or alcohol addiction (> 8 drinks/week)
  2. Pregnancy /breast feeding
  3. Severely impaired renal function, GFR < 30 ml/min
  4. Impaired liver function (ALT/AST transaminase count 3fold higher than normal values) or liver disease with reduced life expectancy <1 year
  5. Valvular AF (moderate- severe mitral insufficiency; relevant mitral steno-sis with a mean pressure gradient >5mmHg)
  6. Long standing persistent (>12 months) and permanent AF
  7. NSTEMI/STEMI/implantated drug eluting stent with indication for dual antiplatelet therapy within 12 months before enrolment
  8. History of complex left atrial ablation procedures. One previous PVI al-lowed.
  9. Clinical indication for extended left atrial ablation procedures (CFAE-, rotor-ablation)
  10. History or presence of left atrial or ventricular thrombus
  11. History of stroke / TIA independent from etiology
  12. Acute major bleedings
  13. Lesion or condition, if considered a significant risk factor for major bleeding. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities
  14. Need for concomitant anitcoagulation in addition to dabigatran
  15. History of previous surgery resulting in contraindication for OAC
  16. History of malignoma resulting in contraindication for OAC
  17. Mechanical prosthetic heart valve or other indication for permanent OAC
  18. Contraindication for MRI (i.e. metal implants unsuitable for MRI, wearing of magnetic or metallic objects that cannot be removed from the body (such as body piercing, implanted electrodes, contraceptive coil), inabil-ity to lie on the back for an extended period of time, uncontrollable claustrophobia, hypersensitivity to noise etc.). Pacemaker and ICD-patients may be included at the discretion of the local investigators/radiologists if MRI is warranted
  19. Hypersensitivity against dabigatran or other ingredients of the medical product
  20. Concomitant medication with dronedarone, ketoconazole, itraconazole, cyclosporine, tacrolimus or other interacting drugs as specified in the drug information
  21. Simultaneous participation in any clinical trial involving administration of an investigational medicinal product within 30 days prior to clinical trial beginning
  22. 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 / hysterectomized or there are any other criteria considered sufficiently reliable by the investigator in individual cases
  23. Conditions which interfere with the study treatment at the discretion of the investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02067182

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

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Heart Center Freiburg University Bad Krozingen Recruiting
Bad Krozingen, Germany, 79189
Contact: Arentz Thomas, MD         
Contact: Jüergen Allgeier         
Heart Center Bad Neustadt-Saale Recruiting
Bad Neustadt-Saale, Germany, 97616
Contact: Thomas Deneke, MD         
Bielefeld Clinical Centre Recruiting
Bielefeld, Germany, 33604
Contact: Christoph Stellbrink, 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.         
University Hospital Cologne Recruiting
Cologne, Germany, 50937
Contact: Daniel Steven, MD         
CCB Markus Hospital Withdrawn
Frankfurt/Main, Germany, D-60431
University Hospital Gießen Recruiting
Gießen, Germany, 35392
Contact: Jörn Schmitt, MD         
Contact: Thomas Neumann, MD         
Sub-Investigator: Christian Hamm, MD         
University Hospital Göttingen Recruiting
Gottingen, Germany, 37075
Contact: Markus Zabel, MD         
Hannover Medical School Recruiting
Hannover, Germany, 30625
Contact: Christian Veltmann, MD         
Contact: Johann Bauersachs, MD         
Westpfalz-Clinic GmbH Kaiserslautern Recruiting
Kaiserslautern, Germany, 67655
Contact: Burghard Schumacher, MD         
Municipal Clinical Center Karlsruhe Recruiting
Karlsruhe, Germany, 76133
Contact: Armin Luik, MD         
Contact: Claus Schmitt, MD         
St. Vincentius Hospital Recruiting
Karlsruhe, Germany, 76137
Contact: Bernd-Dieter Gonska, MD         
Heart Center Leipzig Recruiting
Leipzig, Germany, 04289
Contact: Gerhard Hindricks, MD         
Ludwigshafen Hospital Recruiting
Ludwigshafen, Germany, 67063
Contact: Thomas Kleemann, MD         
Hospital Lüdenscheid Recruiting
Lüdenscheid, Germany, 58515
Contact: Markus Zarske, MD         
Contact: Bernd Lemke, MD         
University Hospital Mannheim Recruiting
Mannheim, Germany, 68167
Contact: Boris Rudic, MD         
Peter Osypka Heart Center Recruiting
Munich, Germany, 81379
Contact: Thorsten Lewalter, MD         
University Hospital Tübingen 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         
Helios Hospital Recruiting
Wuppertal, Germany, 42117
Contact: Armin Sause, MD         
Sponsors and Collaborators
Georg Nickenig
Boehringer Ingelheim

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Georg Nickenig, Prof., University Hospital, Bonn Identifier: NCT02067182     History of Changes
Other Study ID Numbers: MED2-201301
2013-003492-35 ( EudraCT Number )
First Posted: February 20, 2014    Key Record Dates
Last Update Posted: September 3, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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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