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

Phase 4

Completed

• Conditions: Atrial Fibrillation; Cardioembolic Events; Oral Anticoagulation
• Interventions: Drug: Dabigatran

• Registration Number: NCT02067182
• Lead Sponsor: Georg Nickenig

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-18
• Study First Submitted QC: 2014-02-18
• Study First Posted: 2014-02-20
• Study Start: 2015-08
• Primary Completion: 2020-09-15
• Study Completion: 2020-09-15
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-04
• Last Update Posted: 2022-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Anticoagulation with Dabigatran	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

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Life-threatening / major / minor bleedings	12 months
Incidence of other thrombotic or thrombo-embolic events (myocardial in-farction, deep vein thrombosis, pulmonary embolism)	12 months
Location, size and number of new micro- and macro-embolic lesions on cerebral MRI	12 months
Severity of neurological deficits assessed by Modified Rankin Scale	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
Incidence of clinically evident cardio-embolic events (stroke, TIA, systemic embolism)	12 months
Hemorrhagic cerebral infarction	12 months

Trial Locations

Locations (19)

Heart Center Bad Neustadt-Saale; 🇩🇪 Bad Neustadt An Der Saale, Germany

University Hospital Mannheim; 🇩🇪 Mannheim, Germany

Heart Center Leipzig; 🇩🇪 Leipzig, Germany

University Hospital Gießen; 🇩🇪 Gießen, Germany

Hannover Medical School; 🇩🇪 Hannover, Germany

St. Vincentius Hospital; 🇩🇪 Karlsruhe, Germany

Bielefeld Clinical Centre; 🇩🇪 Bielefeld, Germany

Hospital Lüdenscheid; 🇩🇪 Lüdenscheid, Germany

Westpfalz-Clinic GmbH Kaiserslautern; 🇩🇪 Kaiserslautern, Germany

Municipal Clinical Center Karlsruhe; 🇩🇪 Karlsruhe, Germany

University Hospital Göttingen; 🇩🇪 Gottingen, Germany

Ludwigshafen Hospital; 🇩🇪 Ludwigshafen, Germany

Peter Osypka Heart Center; 🇩🇪 Munich, Germany

Schwarzwald-Baar Hospital Villingen Schwenningen; 🇩🇪 Villingen Schwenningen, Germany

Helios Hospital; 🇩🇪 Wuppertal, Germany

Dept. of Medicine-Cardiology University Clinic Bonn; 🇩🇪 Bonn, Germany

Heart Center Freiburg University Bad Krozingen; 🇩🇪 Bad Krozingen, Germany

University Hospital Cologne; 🇩🇪 Cologne, Germany

University Hospital Tübingen; 🇩🇪 Tübingen, Germany