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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 May 2017 by Georg Nickenig, University Hospital, Bonn
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Georg Nickenig, University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT02067182
First received: February 18, 2014
Last updated: May 10, 2017
Last verified: May 2017
February 18, 2014
May 10, 2017
August 2015
August 2018   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT02067182 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
  • Major / minor bleeding events [ Time Frame: 12 months ]
  • Clinically evident cardio-embolic events [ Time Frame: 12 months ]
  • Serious Adverse Events [ Time Frame: 12 months ]
Same as current
 
Prevention of Silent Cerebral Thromboembolism by Oral Anticoagulation With Dabigatran After Pulmonary Vein Isolation for Atrial Fibrillation
Prevention of Silent Cerebral Thromboembolism by Oral Anticoagulation With Dabigatran After Pulmonary Vein Isolation for Atrial Fibrillation
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Atrial Fibrillation
  • Cardioembolic Events
  • Oral Anticoagulation
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
  • 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
    Intervention: Drug: Dabigatran
  • No Intervention: No Oral Anticoagulation
Schrickel JW, Linhart M, Bänsch D, Thomas D, Nickenig G. Rationale and design of the ODIn-AF Trial: randomized evaluation of the prevention of silent cerebral thromboembolism by oral anticoagulation with dabigatran after pulmonary vein isolation for atrial fibrillation. Clin Res Cardiol. 2016 Feb;105(2):95-105. doi: 10.1007/s00392-015-0933-1. Epub 2015 Oct 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
630
August 2019
August 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact: Georg Nickenig, Prof. +49-228-287-15217 georg.nickenig@ukb.uni-bonn.de
Contact: Jan W Schrickel, Prof. +49-228-287-15217 jan.schrickel@ukb.uni-bonn.de
Germany
 
 
NCT02067182
MED2-201301
2013-003492-35 ( EudraCT Number )
Yes
Not Provided
Not Provided
Georg Nickenig, University Hospital, Bonn
Georg Nickenig
Boehringer Ingelheim
Not Provided
University Hospital, Bonn
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP