Appendix 1 Drug Administration and Switching Rules of OAC Treatment
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Appendix 1 Drug administration and switching rules of OAC treatment
Dabigatran was the first new oral anticoagulant that was approved for OAC in patients with non-valvular AF [16]. The safe and efficient use of dabigatran in the blanking period after left atrial ablation procedures could be shown [32,33]. Patients will be randomzed to the following two interventional arms: • Experimental arm: OAC with dabigatran for 12 months • Control arm: No OAC (no placebo medication) for 12 months. AF recurrences in the Control arm will lead to initiation of OAC therapy with dabigatran. The recommended daily dose [19] of Pradaxa® is one 150 mg capsule twice daily. For the following patients the recommended daily dose of Pradaxa® is one 110 mg capsule twice daily: • Patients aged 80 years or above • Patients who receive concomitant verapamil For the following groups, the daily dose of Pradaxa® of 300 mg or 220 mg daily is selected based on an individual assessment of the thromboembolic risk and the risk of bleeding: • Patients aged between 75-79 years • Patients with moderate renal impairment (Cr-Cl 30-50 ml/min)
If at the timepoint of randomisation, previous anticoagulation with other anticoagulants than dabigatran is performed (Vit. K antagonist, heparines, rivaroxaban, apixaban) allocation to dabigatran treatment will be performed according to the manufacturers recommendations: • From Vit. K antagonists to dabigatran: The Vit. K antagonist should be stopped. Dabigatran can be given as soon as the INR is < 2.5. • From rivaroxaban to dabigatran: Rivaroxaban should be stopped. Dabigatran can be given 24 hours ± two hours after the last dose of rivaroxaban. • From apixaban to dabigatran: Apixaban should be stopped. Dabigatran can be given 12 hours ± one hour after the last dose of apixaban. • From edoxaban zu dabigatran: Edoxaban should be stopped. Dabigatran can be given 24 hours ± two hours after the last dose of edoxaban. • From dabigatran to dabigratan: Continue dabigatran etexilate at the same dose as before. "