Atrial High Rate EpisodesPhase 3NOAHNCT02618577
Non-vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes
A Phase 3 study testing Edoxaban and ASA in people with Atrial High Rate Episodes, run by Atrial Fibrillation Network at 18 sites in 18 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Atrial High Rate Episodes
- What is being tested?
- Edoxaban and ASA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,608 participants
- Where
- 18 sitesin 18 countries
- Study dates
- Feb 2016to 31 Dec 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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:
Show all 13Show fewer
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
18 sites in 18 countries.
18 sites in 18 countries
About this study
Official title: Non-vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes - An Investigator-driven, Prospective, Randomised, Double-blind, Multi-centre Trial Initiated by the European Society of Cardiology and AFNET
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.
Read the detailed description
Atrial fibrillation (AF) is a common cause of stroke, especially ischemic stroke. So far, all available data that demonstrate a beneficial effect of oral anticoagulation for stroke prevention have been collected in populations with AF documented by conventional ECG recordings. It is well established that a large proportion of AF episodes remain undiagnosed ("silent AF"), and many of these patients present with a stroke as the first clinical sign of AF. Earlier initiation of anticoagulation could prevent such events. Continuous monitoring of atrial rhythm by implanted devices could close this diagnostic gap. Pacemakers, defibrillators, and cardiac resynchronisation devices already provide automated algorithms alerting to the occurrence of highly organised atrial tachyarrhythmia episodes, also called "subclinical atrial fibrillation" or, more commonly, "atrial high rate episodes" (AHRE). Data from large prospectively followed patient cohorts demonstrated that stroke rate is increased in patients with AHRE. A sizeable portion of these patients develops clinically detected AF over time. In these patients, AHRE can be considered as an early manifestation of paroxysmal AF. A few AHRE patients do not develop clinically overt AF, and the absolute stroke rates are lower in patients with AHRE when compared to stroke rates in patients with clinically diagnosed AF. In light of the bleeding complications associated with oral anticoagulant therapy, there is thus uncertainty about the optimal antithrombotic therapy in patients with AHREs.
The Non-vitamin K antagonist Oral anticoagulants (NOACs) provide similar or slightly better stroke prevention, and appear slightly safer compared to vitamin K antagonists (VKAs). In addition, no individual therapy adjustment of NOACs has to be performed. Edoxaban, a newly introduced NOAC, at a dose regime of 60 mg once daily (OD) has a favourable profile compared to dose-adjusted VKA therapy: In the ENGAGE-TIMI 48 trial, edoxaban prevented strokes at least as effectively as VKA therapy but caused less major bleeding events than VKA therapy.
- Conditions
- Atrial High Rate Episodes
- Being tested
- Edoxaban, ASA
- Keywords
- Anticoagulation, Atrial High Rate Episodes, Atrial Fibrillation, VKA, NOAC
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EdoxabanDrug
Also called Lixiana, Savaysa
Edoxaban will be applied at the therapeutic dose approved for stroke prevention in non-valvular AF
ASADrug
Also called ASS
ASA 100 mg tablets or Placebo, based on accepted indication for the latter, including peripheral or coronary artery disease, a prior myocardial infarction, or a prior stroke.
| Study group | Role | What they receive |
|---|---|---|
| Edoxaban | Experimental | Edoxaban will be applied in NOAH at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics:
Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole. Receives: Drug: Edoxaban |
| ASA or Placebo | Active comparator | Either one tablet of ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg or one placebo tablet matching in colour, weight, form and size to ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg will be administered per day depending on the indication for use of antiplatelet therapy as assessed by the responsible investigator Receives: Drug: ASA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Stroke, Systemic Embolism, or Cardiovascular Death
Time from randomisation to the first occurrence of stroke, systemic embolism, or cardiovascular death; incidence of first occurence of outcome measure.
Measured: 28 months
Secondary outcomes (10)
Components of the Primary Outcome, Stroke
Time from randomisation to the first occurrence of ischemic stroke; incidence of first occurence of outcome measure.
Measured: 28 months
Major Adverse Cardiac Events (MACEs: Cardiac Death, Myocardial Infarction, Acute Coronary Syndrome (ACS)
PCI, CABG
Measured: 28 months
All-cause Death
All-cause death
Measured: 28 months
Major Bleeding Events
according to the International Society on Thrombosis and Haemostasis (ISTH) definitions
Measured: 28 months
Quality of Life Changes at 12 and 24 Months Compared to Baseline
Adjusted mean change from baseline at 12 and 24 months of Quality of life as assessed by the EuroQol Group 5-Dimension 5-Level questionnaire (EQ-5D-5L): The resulting score of the UK index ranges from 1 (for the best state) to - 0.285 (for the worst state), with 5.1% of the states valued as worse than dead. EQ5D- VAS: visual-analogue scale (0 worst to 100 best).
Subscales of the UK index score were combined by adding up EQ-5D-5L index values with STATA using the English (ENG) Devlin value set, Version 1.1 (Updated 01/12/2020).
Karnofsky Performance Scale is an 11-point scale from 0 to 100 (0 worst to 100 best).
Measured: Baseline, 12 months and 24 months.
Patient Satisfaction at 12 and 24 Months Compared to Baseline
Adjusted change from baseline at 12 and 24 months measured by the Perception of Anticoagulant Treatment Questionnaire: For convenience score, a 0 - 100 scale; for satisfaction score a 0 - 100 scale; for both scores, the higher the score, the higher the convenience/satisfaction.
Measured: Baseline, 12 months and 24 months.
Cost Effectiveness and Health Resource Utilisation
estimated by quantification of relevant events, interventions, nights spent in hospital and cardiovascular therapies
Measured: 28 months
Autonomy Status
Autonomy status only in patients with stroke during study participation, assessed at 24 month by modified Rankin scale. (Score ranges from 1 to 8, a higher score indicates a higher grade of disability)
Measured: Baseline and 24 months
Components of the Primary Outcome, Systemic Embolism
Time from randomisation to the first occurrence of systemic embolism; incidence of first occurence of outcome measure.
Measured: 28 months
Components of the Primary Outcome, Cardiovascular Death
Time from randomisation to the first occurrence of cardiovascular death; incidence of first occurence of outcome measure.
Measured: 28 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startFeb 2016
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Why it stopped: following a recommendation from the data safety and monitoring board due to safety concerns and a tendency towards futility.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atrial High Rate EpisodesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 3b
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,608 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atrial Fibrillation Network
- Sponsor type
- University, hospital or other
- Collaborators
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company, Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
- Responsible party
- Sponsor
- Investigators
- Paulus Kirchhof, Prof. Dr., Principal investigator, University Clinic of Hamburg-Eppendorf, Hamburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02618577
- Sponsor's protocol ID
- NOAH - AFNET 6
- Other IDs
- 2015-003997-33, 2015
- Acronym
- NOAH
- Status last verified
- Feb 2025
- First submitted
- 27 Nov 2015
- Last updated
- 6 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Bertaglia E, Blank B, Blomstrom-Lundqvist C, Brandes A, Cabanelas N, Dan GA, Dichtl W, Goette A, de Groot JR, Lubinski A, Marijon E, Merkely B, Mont L, Piorkowski C, Sarkozy A, Sulke N, Vardas P, Velchev V, Wichterle D, Kirchhof P. Atrial high-rate episodes: prevalence, stroke risk, implications for management, and clinical gaps in evidence. Europace. 2019 Oct 1;21(10):1459-1467. doi: 10.1093/europace/euz172.
PubMed 31377792Kirchhof P, Blank BF, Calvert M, Camm AJ, Chlouverakis G, Diener HC, Goette A, Huening A, Lip GYH, Simantirakis E, Vardas P. Probing oral anticoagulation in patients with atrial high rate episodes: Rationale and design of the Non-vitamin K antagonist Oral anticoagulants in patients with Atrial High rate episodes (NOAH-AFNET 6) trial. Am Heart J. 2017 Aug;190:12-18. doi: 10.1016/j.ahj.2017.04.015. Epub 2017 May 3.
PubMed 28760205Kirchhof P, Toennis T, Goette A, Camm AJ, Diener HC, Becher N, Bertaglia E, Blomstrom Lundqvist C, Borlich M, Brandes A, Cabanelas N, Calvert M, Chlouverakis G, Dan GA, de Groot JR, Dichtl W, Kravchuk B, Lubinski A, Marijon E, Merkely B, Mont L, Ozga AK, Rajappan K, Sarkozy A, Scherr D, Sznajder R, Velchev V, Wichterle D, Sehner S, Simantirakis E, Lip GYH, Vardas P, Schotten U, Zapf A; NOAH-AFNET 6 Investigators; NOAH-AFNET6 sites and investigators. Anticoagulation with Edoxaban in Patients with Atrial High-Rate Episodes. N Engl J Med. 2023 Sep 28;389(13):1167-1179. doi: 10.1056/NEJMoa2303062. Epub 2023 Aug 25.
PubMed 37622677
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes - An Investigator-driven, Prospective, Randomised, Double-blind, Multi-centre Trial Initiated by the European Society of Cardiology and AFNET
- ClinicalTrials.gov ID
- NCT02618577
- Acronym / sponsor ID
- NOAH / NOAH - AFNET 6
- Conditions
- Atrial High Rate Episodes
- Keywords
- Anticoagulation, Atrial High Rate Episodes, Atrial Fibrillation, VKA, NOAC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: following a recommendation from the data safety and monitoring board due to safety concerns and a tendency towards futility.
- Enrolment
- 2,608 participants (actual)
- Lead sponsor
- Atrial Fibrillation NetworkUniversity, hospital or other
- Collaborators
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company, Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
- Study start
- Feb 2016 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 1 Dec 2015 (estimated)
- Results
- Posted 6 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Atrial fibrillation (AF) is a common cause of stroke, especially ischemic stroke. So far, all available data that demonstrate a beneficial effect of oral anticoagulation for stroke prevention have been collected in populations with AF documented by conventional ECG recordings. It is well established that a large proportion of AF episodes remain undiagnosed ("silent AF"), and many of these patients present with a stroke as the first clinical sign of AF. Earlier initiation of anticoagulation could prevent such events. Continuous monitoring of atrial rhythm by implanted devices could close this diagnostic gap. Pacemakers, defibrillators, and cardiac resynchronisation devices already provide automated algorithms alerting to the occurrence of highly organised atrial tachyarrhythmia episodes, also called "subclinical atrial fibrillation" or, more commonly, "atrial high rate episodes" (AHRE). Data from large prospectively followed patient cohorts demonstrated that stroke rate is increased in patients with AHRE. A sizeable portion of these patients develops clinically detected AF over time. In these patients, AHRE can be considered as an early manifestation of paroxysmal AF. A few AHRE patients do not develop clinically overt AF, and the absolute stroke rates are lower in patients with AHRE when compared to stroke rates in patients with clinically diagnosed AF. In light of the bleeding complications associated with oral anticoagulant therapy, there is thus uncertainty about the optimal antithrombotic therapy in patients with AHREs.
The Non-vitamin K antagonist Oral anticoagulants (NOACs) provide similar or slightly better stroke prevention, and appear slightly safer compared to vitamin K antagonists (VKAs). In addition, no individual therapy adjustment of NOACs has to be performed. Edoxaban, a newly introduced NOAC, at a dose regime of 60 mg once daily (OD) has a favourable profile compared to dose-adjusted VKA therapy: In the ENGAGE-TIMI 48 trial, edoxaban prevented strokes at least as effectively as VKA therapy but caused less major bleeding events than VKA therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Phase 3b
| Arm | Type | Receives |
|---|---|---|
| Edoxaban | Experimental | Drug: EdoxabanEdoxaban will be applied in NOAH at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole. |
| ASA or Placebo | Active comparator | Drug: ASAEither one tablet of ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg or one placebo tablet matching in colour, weight, form and size to ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg will be administered per day depending on the indication for use of antiplatelet therapy as assessed by the responsible investigator |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EdoxabanAlso: Lixiana, SavaysaEdoxaban will be applied at the therapeutic dose approved for stroke prevention in non-valvular AF | Drug | Edoxaban |
| ASAAlso: ASSASA 100 mg tablets or Placebo, based on accepted indication for the latter, including peripheral or coronary artery disease, a prior myocardial infarction, or a prior stroke. | Drug | ASA or Placebo |
Primary outcome
Composite of Stroke, Systemic Embolism, or Cardiovascular Death
Time frame: 28 months
Time from randomisation to the first occurrence of stroke, systemic embolism, or cardiovascular death; incidence of first occurence of outcome measure.
10 secondary outcomes
Components of the Primary Outcome, Stroke
Time frame: 28 months
Major Adverse Cardiac Events (MACEs: Cardiac Death, Myocardial Infarction, Acute Coronary Syndrome (ACS)
Time frame: 28 months
All-cause Death
Time frame: 28 months
Major Bleeding Events
Time frame: 28 months
Quality of Life Changes at 12 and 24 Months Compared to Baseline
Time frame: Baseline, 12 months and 24 months.
Patient Satisfaction at 12 and 24 Months Compared to Baseline
Time frame: Baseline, 12 months and 24 months.
Cost Effectiveness and Health Resource Utilisation
Time frame: 28 months
Autonomy Status
Time frame: Baseline and 24 months
Components of the Primary Outcome, Systemic Embolism
Time frame: 28 months
Components of the Primary Outcome, Cardiovascular Death
Time frame: 28 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31377792Bertaglia E, Blank B, Blomstrom-Lundqvist C, Brandes A, Cabanelas N, Dan GA, Dichtl W, Goette A, de Groot JR, Lubinski A, Marijon E, Merkely B, Mont L, Piorkowski C, Sarkozy A, Sulke N, Vardas P, Velchev V, Wichterle D, Kirchhof P. Atrial high-rate episodes: prevalence, stroke risk, implications for management, and clinical gaps in evidence. Europace. 2019 Oct 1;21(10):1459-1467. doi: 10.1093/europace/euz172.
- Background: PubMed 28760205Kirchhof P, Blank BF, Calvert M, Camm AJ, Chlouverakis G, Diener HC, Goette A, Huening A, Lip GYH, Simantirakis E, Vardas P. Probing oral anticoagulation in patients with atrial high rate episodes: Rationale and design of the Non-vitamin K antagonist Oral anticoagulants in patients with Atrial High rate episodes (NOAH-AFNET 6) trial. Am Heart J. 2017 Aug;190:12-18. doi: 10.1016/j.ahj.2017.04.015. Epub 2017 May 3.
- Derived from this study: PubMed 37622677Kirchhof P, Toennis T, Goette A, Camm AJ, Diener HC, Becher N, Bertaglia E, Blomstrom Lundqvist C, Borlich M, Brandes A, Cabanelas N, Calvert M, Chlouverakis G, Dan GA, de Groot JR, Dichtl W, Kravchuk B, Lubinski A, Marijon E, Merkely B, Mont L, Ozga AK, Rajappan K, Sarkozy A, Scherr D, Sznajder R, Velchev V, Wichterle D, Sehner S, Simantirakis E, Lip GYH, Vardas P, Schotten U, Zapf A; NOAH-AFNET 6 Investigators; NOAH-AFNET6 sites and investigators. Anticoagulation with Edoxaban in Patients with Atrial High-Rate Episodes. N Engl J Med. 2023 Sep 28;389(13):1167-1179. doi: 10.1056/NEJMoa2303062. Epub 2023 Aug 25.
- NOAH TrialLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paulus Kirchhof, Prof. Dr. principal investigator
University Clinic of Hamburg-Eppendorf, Hamburg, Germany
18 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Edoxaban and ASA in people with Atrial High Rate Episodes, run by Atrial Fibrillation Network at 18 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Austria, Belgium, Bulgaria, Czechia, Denmark and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of Stroke, Systemic Embolism, or Cardiovascular Death (time frame: 28 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02618577, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.