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NOAH–AFNET 6 trial terminates ahead of time (NOAH AFNET 6 trial)


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The NOAH – AFNET 6 trial which is conducted to evaluate the potential benefit of oral anticoagulation in patients with atrial high rate episodes (AHRE) is going to be terminated prematurely. The reason for early termination is an observed trend towards futility for efficacy combined with expected safety concerns. Following a recommendation of the study scientific committees, on 2 September 2022, AFNET decided to orderly terminate the NOAH – AFNET 6 trial in the coming weeks. The study results will be available next year.

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Update 19/05/2024 (subanalysis)
In patients with device-detected atrial fibrillation and a previous stroke, oral anticoagulation leads to more bleeding without a significant reduction in the incidence of stroke. This is the result of a sub-analysis of the NOAH AFNET 6 trial.

It was presented on 19 May 2020 at the annual congress of the American Heart Rhythm Society (HRS) in Boston, USA. To the press release of the Atrial Fibrillation NETwork (AFNET)

Update 09/04/2024 (subanalysis)
In patients with device-detected atrial fibrillation and several concomitant diseases, oral anticoagulation leads to more bleeding without a significant reduction in the frequency of strokes. This is the result of a sub-analysis of the NOAH AFNET 6 trial.

It was presented on 9 April 2020 at the annual congress of the European Heart Rhythm Association (EHRA) in Berlin and published simultaneously in the European Heart Journal. To the press release of the Atrial Fibrillation NETwork(AFNET).

Update 13/11/2023 (subanalysis)
In patients with device-detected atrial fibrillation, the risk of stroke appears to be low (1% per year) compared to ECG-detected atrial fibrillation, even in patients with long episodes. Oral anticoagulation may slightly reduce the risk of stroke, but may also increase the risk of major bleeding. This is the result of a subanalysis of the NOAH AFNET 6 study.

It was presented at the American Heart Association (AHA) annual meeting in Philadelphia, USA, and published in the European Heart Journal. To the press release.

Update 25/08/2023 (main result)
In September 2022, the decision was made to orderly terminate the NOAH AFNET 6 trial under controlled conditions. Analysis of the full data now confirms that in patients with atrial high rate episodes (AHRE), but without ECG-documented atrial fibrillation (AF), oral anticoagulation increases bleeding without reducing strokes. Stroke rate was low in patients with AHRE with and without oral anticoagulation.

The results were presented at the European Society of Cardiology (ESC) annual congress in Amsterdam on 25 August and published in the New England Journal of Medicine. To the press release.

 

“We have to wait for the analysis of the full data. What we know so far suggests that oral anticoagulation is not as effective as we hoped for in patients with AHRE”, explains Prof. Paulus Kirchhof, principal investigator of NOAH – AFNET 6.

The AFNET is conducting NOAH – AFNET 6 (Non-vitamin K antagonist Oral anticoagulants in patients with AHRE) since 2016 as an investigator-initiated trial in 18 European countries, financially supported by Daiichi Sankyo Europe and the German Centre for Cardiovascular Research (DZHK). Recently the target number of 2538 randomised and treated patients was reached. Early termination of the study means for the participants that they are advised to come timely to the study site for a final visit at which the intake of study medication ends.

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