on-vitamin K antagonist Oral anticoagulants in patients with Atrial High rate episodes

Phase 3

Recruiting

• Conditions: atrial high rate episodes (AHRE); subclinical atrial fibrillation; 10082206

• Registration Number: NL-OMON52989
• Lead Sponsor: Kompetenznetz Vorhofflimmern e.V. (AFNET) [Atrial Fibrillation NETwork]

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 75

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
-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.
-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 antihypertensive 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

- Patients with history of overt AF or atrial flutter
- patients with a clear contraindication for oral anticoagulation,
- patients with a clear need for oral anticoagulation,
- patients with indication for long-term antiplatelet therapy other than
acetylsalicylic acid (ASA) or a need for treatment with any antiplatelet agent
in addition to edoxaban, especially dual antiplatelet therapy (DAPT), are not
suitable for NOAH - AFNET 6.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Time from randomisation to the first occurrence of stroke, systemic embolism,<br /><br>or cardiovascular death. A detailed definition of these outcome events is<br /><br>provided in Appendix III.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-Components of the primary outcome<br /><br>-Major Adverse Cardiac Events (MACEs: cardiovascular death, myocardial<br /><br>infarction, acute coronary syndrome (ACS), PCI, CABG)<br /><br>- stroke or systemic arterial embolism<br /><br>-All-cause death<br /><br>-Major bleeding events according to the ISTH definitions<br /><br>-Quality of life changes at 12 and 24 months compared to baseline<br /><br>-Patient satisfaction at 12 and 24 months compared to baseline<br /><br>-Cost effectiveness and health resource utilisation<br /><br>-Patient autonomy changes at 12 and 24 months compared to baseline including<br /><br>chronic consequences of stroke (aphasia, hemianopia (*mild stroke*))<br /><br>-Cognitive function at 12 and 24 months compared to baseline</p><br>