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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by 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: February 20, 2014
Last verified: February 2014

February 18, 2014
February 20, 2014
October 2014
June 2016   (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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Incidence of clinically evident cardio-embolic events (stroke, TIA, systemic embolism) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Severity of neurological deficits assessed by Modified Rankin Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Incidence of other thrombotic or thrombo-embolic events (myocardial in-farction, deep vein thrombosis, pulmonary embolism) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Life-threatening / major / minor bleedings [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Hemorrhagic cerebral infarction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • All-cause mortality / Cardiovascular mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Correlation of cardio-embolic events to method used for PVI (cryo-balloon versus RF) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Quality of life questionnaire (AF-specific symptoms, SF36) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Neuropsychological questionnaire (RBANS A&B) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Assessment of neurocognitive deficits: Minimental Test [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
  • Major / minor bleeding events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Clinically evident cardio-embolic events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Serious Adverse Events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Atrial Fibrillation
  • Cardioembolic Events
  • Oral Anticoagulation
Drug: Dabigatran
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
630
June 2016
June 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
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
Yes
Georg Nickenig, University Hospital, Bonn
Georg Nickenig
Boehringer Ingelheim
Not Provided
University Hospital, Bonn
February 2014

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