Table I.
Inclusion and exclusion criteria of the NOAH–AFNET 6 trial
| Inclusion criteria | Exclusion criteria |
|---|---|
| I1. Pacemaker or defibrillator implanted for any reason with feature of detection of AHRE, implanted at least 2 m prior to randomization | E1. Any disease that limits life expectancy to less than 1 y |
| I2. AHRE detection feature activated | E2. Participation in another controlled clinical trial, either within the past 2 months or still ongoing |
| I3. AHRE (≥180 beats/min atrial rate and ≥6-min duration) documented by the implanted device via its atrial lead and stored digitally | E3. Previous participation in the present trial NOAH–AFNET 6 |
| I4. Age ≥65 y | E4. Drug abuse or clinically manifest alcohol abuse |
| I5. In addition, at least 1 of the following cardiovascular conditions - Age ≥75 y, - Heart failure (clinically overt or LVEF <45%), - Arterial hypertension (long-term treatment for hypertension, estimated need for continuous antihypertensive therapy, or resting blood pressure >145/90 mm Hg), - Diabetes mellitus, - Prior stroke or TIA, or - Vascular disease (peripheral, carotid/cerebral, or aortic plaques on TEE). |
E5. Any history of AF or atrial flutter or presence of AF at baseline 12-lead ECG |
| I6. Provision of signed informed consent | E6. Indication for oral anticoagulation (eg, deep venous thrombosis) |
| E7. Contraindication for oral anticoagulation in general | |
| E8. Contraindication for edoxaban as stated in the current SmPC | |
| E9. Indication for long-term antiplatelet therapy other than acetylsalicylic acid, especially DAPT | |
| E10. Acute coronary syndrome, coronary revascularization (PCI or bypass surgery), or overt stroke within 30 d prior to randomization | |
| E11. End stage renal disease (CrCl <15 mL/min) |
The inclusion criteria I4 and I5 closely resemble the criteria of a CHA2DS2-VASc score of ≥2 in patients with diagnosed AF. Patients with a transient requirement for dual antiplatelet therapy (DAPT, eg, after receiving a stent) will be eligible when the need for DAPT is no longer present.
LVEF, Left ventricular ejection fraction; TIA, transient ischemic attack; TEE, transesophageal echocardiogram; SmPC, summary of product characteristics; DAPT, dual-antiplatelet therapy; PCI, percutaneous coronary intervention; CrCL, creatinine clearance.