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Atrial FibrillationPhase 4ODIn-AFNCT02067182

Prevention of Silent Cerebral Thromboembolism by Oral Anticoagulation With Dabigatran After Pulmonary Vein Isolation for Atrial Fibrillation

A Phase 4 study testing Dabigatran in people with Atrial Fibrillation and Cardioembolic Events, run by Georg Nickenig at 19 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Dabigatran
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
19 sitesGermany
Study dates
Aug 2015to 15 Sep 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent
  • 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.
  • CHA2DS2VASc score ≥2
  • Randomization criteria:
  • 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
  • No clinical evidence of recurrent AF after completing 3 months blanking and 3 months observation period as assessed by symptoms
  • No other relevant contraindication for OAC assessed by randomization MRI of the brain

Who cannot join

  • 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)
  • Pregnancy /breast feeding
  • Severely impaired renal function, GFR < 30 ml/min
  • Impaired liver function (ALT/AST transaminase count 3fold higher than normal values) or liver disease with reduced life expectancy <1 year
  • Valvular AF (moderate- severe mitral insufficiency; relevant mitral steno-sis with a mean pressure gradient >5mmHg)
  • Long standing persistent (>12 months) and permanent AF
Show all 23Show fewer
  • NSTEMI/STEMI/implantated drug eluting stent with indication for dual antiplatelet therapy within 12 months before enrolment
  • History of complex left atrial ablation procedures. One previous PVI al-lowed.
  • Clinical indication for extended left atrial ablation procedures (CFAE-, rotor-ablation)
  • History or presence of left atrial or ventricular thrombus
  • History of stroke / TIA independent from etiology
  • Acute major bleedings
  • 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
  • Need for concomitant anitcoagulation in addition to dabigatran
  • History of previous surgery resulting in contraindication for OAC
  • History of malignoma resulting in contraindication for OAC
  • Mechanical prosthetic heart valve or other indication for permanent OAC
  • 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
  • Hypersensitivity against dabigatran or other ingredients of the medical product
  • 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 / hysterectomized 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

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

Germany19 sites

  • Heart Center Freiburg University Bad Krozingen

    Bad Krozingen, 79189

  • Heart Center Bad Neustadt-Saale

    Bad Neustadt an der Saale, 97616

  • Bielefeld Clinical Centre

    Bielefeld, 33604

  • Dept. of Medicine-Cardiology University Clinic Bonn

    Bonn, D-53105

  • University Hospital Cologne

    Cologne, 50937

  • University Hospital Gießen

    Giessen, 35392

  • University Hospital Göttingen

    Göttingen, 37075

  • Hannover Medical School

    Hanover, 30625

  • Westpfalz-Clinic GmbH Kaiserslautern

    Kaiserslautern, 67655

  • Municipal Clinical Center Karlsruhe

    Karlsruhe, 76133

  • St. Vincentius Hospital

    Karlsruhe, 76137

  • Heart Center Leipzig

    Leipzig, 04289

  • Hospital Lüdenscheid

    Lüdenscheid, 58515

  • Ludwigshafen Hospital

    Ludwigshafen, 67063

  • University Hospital Mannheim

    Mannheim, 68167

  • Peter Osypka Heart Center

    Munich, 81379

  • University Hospital Tübingen

    Tübingen, 72076

  • Schwarzwald-Baar Hospital Villingen Schwenningen

    Villingen-Schwenningen, 78050

  • Helios Hospital

    Wuppertal, 42117

Other trials in Germany

About this study

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.

Being tested
Dabigatran
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DabigatranDrug

    • 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
Study groups in NCT02067182
Study groupRoleWhat they receive
Oral Anticoagulation with DabigatranExperimentalThe 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
Receives: Drug: Dabigatran
No Oral AnticoagulationNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 12 months

Secondary outcomes (12)

  1. Location, size and number of new micro- and macro-embolic lesions on cerebral MRI

    Measured: 12 months

  2. Incidence of clinically evident cardio-embolic events (stroke, TIA, systemic embolism)

    Measured: 12 months

  3. Severity of neurological deficits assessed by Modified Rankin Scale

    Measured: 12 months

  4. Incidence of other thrombotic or thrombo-embolic events (myocardial in-farction, deep vein thrombosis, pulmonary embolism)

    Measured: 12 months

  5. Life-threatening / major / minor bleedings

    Measured: 12 months

  6. Hemorrhagic cerebral infarction

    Measured: 12 months

  7. All-cause mortality / Cardiovascular mortality

    Measured: 12 months

  8. Correlation of cardio-embolic events to method used for PVI (cryo-balloon versus RF)

    Measured: 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)

    Measured: 12 months

  10. Quality of life questionnaire (AF-specific symptoms, SF36)

    Measured: 12 months

  11. Neuropsychological questionnaire (RBANS A&B)

    Measured: 12 months

  12. Assessment of neurocognitive deficits: Minimental Test

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2014 (estimated)
  2. Study startAug 2015
  3. Primary completion15 Sep 2020
  4. Study completion15 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02067182
Sponsor's protocol ID
MED2-201301
Other IDs
2013-003492-35
Acronym
ODIn-AF
Status last verified
Nov 2022
First submitted
18 Feb 2014
Last updated
7 Nov 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • Schrickel JW, Linhart M, Bansch 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.

    PubMed 26514352

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dabigatran in people with Atrial Fibrillation and Cardioembolic Events, run by Georg Nickenig at 19 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02067182, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2022.

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