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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003492-35 | EudraCT Number |
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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Anticoagulation with Dabigatran | Experimental | 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:
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:
|
|
| No Oral Anticoagulation | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dabigatran | Drug |
AF-free patients as assessed by 72h Holter ECG and symptoms wil be random-izedals to the following two interventional arms:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Location, size and number of new micro- and macro-embolic lesions on cerebral MRI | 12 months | |
| Incidence of clinically evident cardio-embolic events (stroke, TIA, systemic embolism) | 12 months | |
| Measure | Description | Time Frame |
|---|---|---|
| Major / minor bleeding events | 12 months | |
| Clinically evident cardio-embolic events | 12 months | |
| Serious Adverse Events |
Inclusion criteria:
Randomization criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Center Freiburg University Bad Krozingen | Bad Krozingen | 79189 | Germany | |||
| Heart Center Bad Neustadt-Saale |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26514352 | Derived | 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. |
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|
| Severity of neurological deficits assessed by Modified Rankin Scale |
| 12 months |
| Incidence of other thrombotic or thrombo-embolic events (myocardial in-farction, deep vein thrombosis, pulmonary embolism) | 12 months |
| Life-threatening / major / minor bleedings | 12 months |
| Hemorrhagic cerebral infarction | 12 months |
| All-cause mortality / Cardiovascular mortality | 12 months |
| Correlation of cardio-embolic events to method used for PVI (cryo-balloon versus RF) | 12 months |
| Correlation of cardio-embolic events with arrhythmia recurrence (atrial fi-brillation or atrial flutter post ablationem with ECG documentation or symp-toms) | 12 months |
| Quality of life questionnaire (AF-specific symptoms, SF36) | 12 months |
| Neuropsychological questionnaire (RBANS A&B) | 12 months |
| Assessment of neurocognitive deficits: Minimental Test | 12 months |
| 12 months |
| Bad Neustadt an der Saale |
| 97616 |
| Germany |
| Bielefeld Clinical Centre | Bielefeld | 33604 | Germany |
| Dept. of Medicine-Cardiology University Clinic Bonn | Bonn | D-53105 | Germany |
| University Hospital Cologne | Cologne | 50937 | Germany |
| University Hospital Gießen | Giessen | 35392 | Germany |
| University Hospital Göttingen | Göttingen | 37075 | Germany |
| Hannover Medical School | Hanover | 30625 | Germany |
| Westpfalz-Clinic GmbH Kaiserslautern | Kaiserslautern | 67655 | Germany |
| Municipal Clinical Center Karlsruhe | Karlsruhe | 76133 | Germany |
| St. Vincentius Hospital | Karlsruhe | 76137 | Germany |
| Heart Center Leipzig | Leipzig | 04289 | Germany |
| Ludwigshafen Hospital | Ludwigshafen | 67063 | Germany |
| Hospital Lüdenscheid | Lüdenscheid | 58515 | Germany |
| University Hospital Mannheim | Mannheim | 68167 | Germany |
| Peter Osypka Heart Center | Munich | 81379 | Germany |
| University Hospital Tübingen | Tübingen | 72076 | Germany |
| Schwarzwald-Baar Hospital Villingen Schwenningen | Villingen-Schwenningen | 78050 | Germany |
| Helios Hospital | Wuppertal | 42117 | Germany |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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