on-vitamin K antagonist oral anticoagulants in patients with atrial high rate episodes

Phase 3

Completed

• Conditions: Atrial high rate episodes; Circulatory System

• Registration Number: ISRCTN17309850
• Lead Sponsor: Kompetenznetz Vorhofflmmern e.V. (Atrial Fibrillation NETwork - AFNET)

Brief Summary

2017 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/28760205 protocol 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37622677/ (added 29/08/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-29
• Study Completion: 2022-12-31
• Last Update Posted: 12 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2535

Inclusion Criteria

Current participant inclusion criteria as of 19/03/2020:
1. Implanted pacemaker, defibrillator or insertable cardiac monitor with feature of detection of AHRE, implanted at least 2 months prior to randomization
2. AHRE detection feature activated adequately according to Suggestions for optimal programming of devices for adequate detection of AHRE
3. AHRE (= 170 bpm atrial rate and = 6 min duration) documented by the implanted device via its atrial lead and stored digitally. AHRE episodes detected in the first 2 months after implantation of a new device involving placement or repositioning of electrodes are not counted. 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 electrodes, are eligible.
4. Aged 65 years or over
5. In addition, at least one of the following cardiovascular conditions leading to a modified CHA2DS2VASc score of 2 or more:
a. Age = 75 years
b. Heart failure (clinically overt or LVEF < 45%)
c. Arterial hypertension (chronic treatment for hypertension, estimated need for continuous antihypertensive therapy or resting blood pressure > 145/90 mmHg)
d. Diabetes mellitus
e. Prior stroke or transient ischemic attack (TIA)
f. Vascular disease (previous myocardial infarction, peripheral, carotid/cerebral, or aortic plaques on transesophageal echocardiogram [TEE])
6. Provision of signed informed consent

Previous participant inclusion criteria as of 27/09/2018:
1. Implanted pacemaker or defibrillator with feature of detection of AHRE, implanted at least 2 months prior to randomisation
2. AHRE detection feature activated adequately according to Suggestions for optimal programming of devices for adequate detection of AHRE
3. AHRE (= 180 bpm atrial rate and = 6 min duration) documented by the implanted device via its atrial lead and stored digitally. AHRE episodes detected in the first 2 months after implantation of a new device involving placement or repositioning of electrodes are not counted. 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 electrodes, are eligible.
4. Aged 65 years or over
5. In addition, at least one of the following cardiovascular conditions leading to a modified CHA2DS2VASc score of 2 or more:
5.1. Age = 75 years;
5.2. Heart failure (clinically overt or LVEF < 45%);
5.3. Arterial hypertension (chronic treatment for hypertension, estimated need for continuous antihyper-tensive therapy or resting blood pressure > 145/90 mmHg);
5.4. Diabetes mellitus;
5.5. Prior stroke or transient ischemic attack (TIA);
5.6. Vascular disease (previous myocardial infarction, peripheral, carotid/cerebral, or aortic plaques on transesophageal echocardiogram [TEE]).
6. Provision of signed informed consent

Previous participant inclusion criteria:
1. Implanted pacemaker or defibrillator with feature of detection of AHRE, i

Exclusion Criteria

1. Any disease that limits life expectancy to less than 1 year
2. Participation in another controlled clinical trial, either within the past two months or still ongoing
3. Previous participation in the present trial NOAH
4. Drug abuse or clinically manifest alcohol abuse. Exclusion criteria related to a cardiac condition
5. Any history of overt AF or atrial flutter
6. Indication for oral anticoagulation (e.g. deep venous thrombosis)
7. Contraindication for oral anticoagulation in general
8. Contraindication for edoxaban as stated in the current SmPC
9. Indication for long-term antiplatelet therapy other than acetylsalicylic acid, especially dual antiplatelet therapy (DAPT) with acetylsalicylic acid and one of the following agents: clopidogrel, prasugrel, or ticagrelor. 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
10. Acute coronary syndrome, coronary revascularisation (PCI or bypass surgery), or overt stroke within 30 days prior to randomisation
11. End stage renal disease (creatinine clearance (CrCl) < 15 ml/min as calculated by the Cockcroft-Gault method)

Study & Design

• Study Type: Interventional
• Study Design: Not specified