Non-vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes

• Status: Recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: All

Summary

NOAH is an investigator-initiated, prospective, parallel-group, double-blind, randomised, multi-centre trial. The objective of the trial is to demonstrate that oral anticoagulation using the NOAC edoxaban is superior to current therapy to pre-vent stroke, systemic embolism, or cardiovascular death in patients with AHRE and at least two stroke risk factors but without AF. The trial will be conducted in several European countries.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Atrial Fibrillation Network; German Atrial Fibrillation Network
• Collaborators: Daiichi Sankyo Europe, GmbH; Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company; Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
• Treatments: Anticoagulants; Edoxaban

Criteria

Inclusion Criteria:

• Pacemaker, defibrillator or insertable cardiac monitor implanted for any reason with feature of detection of AHRE, implanted at least 2 months prior to randomisation

• AHRE detection feature activated for adequate detection of AHRE (refer to Appendix XIII)

• AHRE (≥ 170 bpm atrial rate and ≥ 6 min duration) documented by the implanted device via its atrial lead and stored digitally. Any AHRE episode recorded is potentially eligible, but AHRE episodes detected in the first 2 months after implantation of a new device involving placement or repositioning of atrial electrodes are not eligible. AHRE episodes recorded in the first two months after a simple "box change" operation, i.e. exchange of a pacemaker or defibrillator device without exchange or repositioning of atrial electrodes, are eligible

• Provision of signed informed consent

• Age ≥ 65 years

In addition, at least one of the following cardiovascular conditions leading to a modified CHA2DS2VASc score of 2 or more:

• Age ≥ 75 years

• Heart failure (clinically overt or LVEF < 45%)

• Arterial hypertension (chronic treatment for hypertension, estimated need for continuous antihyper-tensive therapy or resting blood pressure > 145/90 mmHg)

• Diabetes mellitus

• Prior stroke or transient ischemic attack (TIA)

• Vascular disease (previous myocardial infarction, peripheral, carotid/cerebral, or aortic plaques on transesophageal echocardiogram [TEE])

• Provision of signed informed consent

Exclusion Criteria:

• Any disease that limits life expectancy to less than 1 year

• Participation in another controlled clinical trial, either within the past two months or still ongoing

• Previous participation in the present trial NOAH - AFNET 6

• Drug abuse or clinically manifest alcohol abuse

• Any history of overt AF or atrial flutter

• Indication for oral anticoagulation (e.g. deep venous thrombosis)

• Contraindication for oral anticoagulation in general

• Contraindication for edoxaban as stated in the current SmPC

• Indication for long-term antiplatelet therapy other than acetylsalicylic acid or a need for treatment with any antiplatelet agent in addition to edoxaban, especially dual antiplatelet therapy (DAPT). Patients with a transient requirement for DAPT (e.g. after receiving a stent) will be eligible when the need for DAPT is no longer present

• Acute coronary syndrome, coronary revascularisation (PCI or bypass surgery), or overt stroke within 30 days prior to randomisation

• End stage renal disease (creatinine clearance (CrCl) < 15 ml/min as calculated by the Cockcroft-Gault method)

• All persons exempt from participation in a clinical trial by law