NOAH - AFNET 6
Research type
Research Study
Full title
Non-vitamin K antagonist Oral anticoagulants in patients with Atrial High rate episodes
IRAS ID
194491
Contact name
Andreas Götte, Professor
Contact email
Sponsor organisation
Kompetenznetz Vorhofflimmern e.V. (AFNET) [Atrial Fibrillation NETwork]
Eudract number
2015-003997-33
ISRCTN Number
ISRCTN17309850
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 6 months, 0 days
Research summary
Research Summary
Patients with Atrial Fibrillation (irregular rhythm and frequency in the hearts atrium) (AF) are known to have an increased risk of stroke. In order to prevent stroke, these patients are treated with anticoagulants (drugs preventing the clotting of blood). Recent advances made in implanted pacemakers and defibrillators have enabled detection of atrial high rate episodes (AHRE) (episodes of increased frequency in the atrium) that are believed to be precursors of AF. Patients with AHREs also have an increased risk of stroke. However, anticoagulants are not commonly used in these patients.
The aim of this trial is to examine, if the new oral anticoagulant edoxaban reduces the risk of stroke in patients with AHREs.
About 2400 patients in 15 European countries will be included in this trial. Patients must be at least 65 years of age, have an increased stroke risk (at least a score of 2 in the ChadVasc scoring system) and have an implanted pacemaker or defibrillator capable of recording AHREs .
Patients included in the trial will be randomly assigned to either treatment with edoxaban or standard treatment (no treatment or treatment with acetylsalicylacid (“Aspirin”). The occurrence of stroke, cardiovascular death and systemic embolism will be compared between these groups. Neither patients, nor their doctors know which group the patient belongs to.
The trial is designed as an event-driven trial, meaning, that the end of the trial is not determined by any fixed date or duration, but by the occurrence of certain events. In this case the trial will end, once 222 first occurrences of stroke, cardiovascular death or systemic embolism (blockage of blood vessels in the body) in patients have been counted, presumably by the end of 2019.Summary of Results
The study involved 2536 patients, with 1270 receiving edoxaban (a blood thinner) and 1266 receiving a placebo. The average age of participants was 78 years, and 37.4% were women. The trial was stopped early after about 21 months due to safety concerns and a lack of evidence that edoxaban was effective.Key findings:
Efficacy: 83 patients in the edoxaban group and 101 in the placebo group experienced major cardiovascular events. This difference was not statistically significant.
Stroke Incidence: Both groups had a low stroke rate of about 1% per year.
Safety: More patients in the edoxaban group experienced serious safety events (149 vs. 114 in the placebo group), indicating a higher risk of major bleeding.
Overall, edoxaban did not significantly reduce the risk of major cardiovascular events compared to placebo but did increase the risk of death and serious bleeding.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
16/EM/0172
Date of REC Opinion
23 May 2016
REC opinion
Further Information Favourable Opinion