Atrial FibrillationPhase 4DANNOAC-AFNCT03129490
The Danish Non-vitamin K Antagonist Oral Anticoagulation Study in Patients With Atrial Fibrillation
A Phase 4 study testing Dabigatran Etexilate Oral Capsule, Rivaroxaban Oral Tablet and Edoxaban Oral Tablet in people with Atrial Fibrillation and Atrial Flutter, run by Herlev and Gentofte Hospital at 38 sites in Denmark.
Trial summary
No randomized head-to-head comparison between the individual Non-vitamin K Antagonist Oral Anticoagulants (NOAC) exists. The DANNOAC-AF study is a nationwide cluster randomized cross-over study comparing efficacy and safety of the four NOACs, edoxaban, apixaban, rivaroxaban and dabigatran for oral anticoagulation in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Atrial Flutter
- What is being tested?
- Dabigatran Etexilate Oral Capsule, Rivaroxaban Oral Tablet and Edoxaban Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11,000 participants
- Where
- 38 sitesDenmark
- Study dates
- 1 Apr 2023to 30 Oct 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of atrial fibrillation or atrial flutter in outpatient clinic or as discharge diagnosis after hospitalization.
- A claimed prescription of a NOAC from a Danish pharmacy within 14 days of discharge or outpatient clinic visit.
Who cannot join
- A prescription of a NOAC within 90 days prior to hospitalization or outpatient clinic visit for atrial fibrillation or atrial flutter.
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
Denmark38 sites
Hjerteklinik Nordjylland
Aalborg
Aarhus University Hospital
Aarhus, 8200
Hjertelægerne i Ballerup
Ballerup Municipality, 2750
Hjertelæge Christian Lange
Copenhagen, 1264
Bispebjerg Hospital - Department of Geriatrics
Copenhagen
Hjerteklinikken Amaliegade
Copenhagen
Hjerteklinikken ved Speciallæge Anders Galløe
Copenhagen
Bispebjerg Hospital - Department of Neurology
Copenhagen NV, 2400
Hjerteklinik Østerbro I/S
Copenhagen Ø, 2100
Rigshospitalet
Copenhagen Ø, 2100
Amager Hospital
Copenhagen S, 2300
Esbjerg Hospital
Esbjerg, 6700
Bispebjerg and Frederiksberg Hospital - Department of Cardiology
Frederiksberg, 2000
Frederiksberg Hjerteklinik
Frederiksberg, 2000
Nordsjællands Hospital - Frederiksund
Frederikssund, 3600
Gentofte Hospital
Gentofte Municipality, 2900
Glostrup Hospital - Department of Emergency Medicine
Glostrup Municipality, 2600
Glostrup Hospital - Department of Medicine / Cardiology
Glostrup Municipality, 2600
Glostrup Hospital - Department of Neurology
Glostrup Municipality, 2600
Herlev-Gentofte Hospital - Department of Medicine
Herlev, 2730
Hjertelægerne i Hillerød
Hillerød, 3400
Nordsjællands Hospital - Hillerød
Hillerød, 3400
Hjørring Hospital
Hjørring, 9800
Holbæk Hospital
Holbæk, 4300
Speciallæge Michael Dilou Jacobsen
Holte, 2840
Hvidovre Hospital
Hvidovre, 2650
Næstved Hospital
Næstved, 4700
Odense University Hospital - Department of Cardiology
Odense, 5000
Odense University Hospital - Department of Emergency Medicine
Odense, 5000
Odense University Hospital - Department of Geriatrics
Odense, 5000
Odense University Hospital - Department of Neurology
Odense, 5000
Bornholms Hospital
Rønne, 3700
Zealand University Hospital - Department of Neurology
Roskilde, 4000
Zealand University Hospital Roskilde - Department of Cardiology
Roskilde, 4000
Slagelse Hospital
Slagelse, 4200
Odense University Hospital Svendborg
Svendborg, 5700
Klinik Hjertesund
Taastrup, 2630
Vejle Hospital
Vejle, 7100
About this study
Official title: The Danish Non-vitamin K Antagonist Oral Anticoagulation Study. A Cluster Randomized Study Comparing Safety and Efficacy of Edoxaban, Apixaban, Rivaroxaban and Dabigatran for Oral Anticoagulation in Atrial Fibrillation (DANNOAC-AF).
No randomized head-to-head comparison between the individual Non-vitamin K Antagonist Oral Anticoagulants (NOAC) exists. The DANNOAC-AF study is a nationwide cluster randomized cross-over study comparing efficacy and safety of the four NOACs, edoxaban, apixaban, rivaroxaban and dabigatran for oral anticoagulation in atrial fibrillation and atrial flutter across Danish hospitals and cardiology clinics.
Read the detailed description
No randomized head-to-head comparison between the individual Non-vitamin K Antagonist Oral Anticoagulants (NOAC) exists, but such data are warranted to evaluate if the four NOACs are equal in stroke prevention without an additional cost of increased bleeding risk. Furthermore, classic randomized trials are highly selective, as elderly and/or fragile patients and patients with comorbidity are underrepresented. Therefore, there is a need of randomized trials that include a broader population of patients.
The DANNOAC-AF study is a nationwide cluster randomized cross-over study comparing efficacy and safety of the four NOACs, edoxaban, apixaban, rivaroxaban and dabigatran for oral anticoagulation in non-valvular atrial fibrillation and atrial flutter across Danish hospitals and cardiology clinics. The aim of the present study is to: 1) examine if the four NOACs are equally effective in preventing strokes, death and hospitalizations without increasing the risk of major bleeding requiring hospitalization; 2) conduct a randomized study that includes elderly and fragile patients and patients with comorbidity that would otherwise not be included in a traditional randomized clinical trial.
For a variety of reasons, Danish hospitals and clinicians often prefer one particular NOAC. This can make work simpler for the busy clinician, although there may also be economic advantages on a local or a regional larger scale. For a period of two years, this study will replace this individually preferred selection with a random selection. The hospitals and clinics that participate in this study will be randomly selected to primarily use one specific NOAC for 6 months at a time during a total period of two years. This only applies to patients with non-valvular atrial fibrillation or atrial flutter that are selected by the physician to be eligible for NOAC treatment.
Endpoints
- Primary efficacy outcome: a composite endpoint of stroke, myocardial infarction, thromboembolic event or all-cause death.
- Secondary efficacy outcomes: Individually components of the primary endpoints; stroke, myocardial infarction, thromboembolism or all-cause death.
- Primary safety outcome: bleeding requiring hospitalization.
- Other effect measures:
- discontinuation of therapy.
- adherence to therapy.
- other reasons of admission to hospital than included in the primary and secondary endpoint.
- Sensitivity analyses:
- primary endpoint stratified by gender.
- primary endpoint stratified by age (≤65, 65-75, >75 years of age).
- primary endpoint stratified by levels of the CHA2DS2VASc score (0-1, 2-3, >3).
- primary endpoint with exclusion of clusters with non-compliance greater than 20% of cluster randomization.
- primary endpoint where the actual treatment is used instead of the allocated treatment.
- primary safety endpoint stratified by HAS-BLED score.
Information of endpoints and comorbidity is obtained from the Danish National Patient Register based on ICD-10 diagnostic codes and information of vital status and date of death will be obtained from the Central Person Register. Drug discontinuation and adherence will be examined using information from the Danish Registry of Medicinal Product Statistics. The prespecified endpoints will be evaluated after 2 years as intention-to-treat analysis. In addition, the prespecified endpoints will be evaluated after 5 and 10 years.
A cluster is defined as a hospital or a cardiology clinic. the clusters will be initiated in the study from 1. of April 2023 to 1. October 2023.
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Being tested
- Dabigatran Etexilate Oral Capsule, Rivaroxaban Oral Tablet, Edoxaban Oral Tablet, Apixaban Oral Tablet
- Keywords
- Atrial Fibrillation, Non-vitamin K antagonist oral anticoagulation, Direct-acting oral anticoagulants, Novel oral anticoagulant drugs, Non-vitamin K antagonist oral anticoagulants, Atrial Flutter
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dabigatran Etexilate Oral CapsuleDrug
After cluster randomization, the cluster will use dabigatran to all their patients with non-valvular atrial fibrillation when possible for six months. Hereafter the cluster will use the other three NOACs for six months one at the time. It is the clusters and not the patient that are randomized.
Rivaroxaban Oral TabletDrug
After cluster randomization, the cluster will use rivaroxaban to all their patients with non-valvular atrial fibrillation when possible for six months. Hereafter the cluster will use the other three NOACs for six months one at the time. It is the clusters and not the patient that are randomized.
Edoxaban Oral TabletDrug
After cluster randomization, the cluster will use edoxaban to all their patients with non-valvular atrial fibrillation when possible for six months. Hereafter the cluster will use the other three NOACs for six months one at the time. It is the clusters and not the patient that are randomized.
Apixaban Oral TabletDrug
After cluster randomization, the cluster will use apixaban to all their patients with non-valvular atrial fibrillation when possible for six months. Hereafter the cluster will use the other three NOACs for six months one at the time. It is the clusters and not the patient that are randomized.
| Study group | Role | What they receive |
|---|---|---|
| Dabigatran | Active comparator | After randomization, the cluster will use dabigatran to all their patients with non-valvular atrial fibrillation when possible for six months. Hereafter the cluster will use the other three NOACs for six months one at the time. Receives: Drug: Dabigatran Etexilate Oral Capsule; Drug: Rivaroxaban Oral Tablet; Drug: Edoxaban Oral Tablet; Drug: Apixaban Oral Tablet |
| Rivaroxaban | Active comparator | After randomization, the cluster will use rivaroxaban to all their patients with non-valvular atrial fibrillation when possible for six months. Hereafter the cluster will use the other three NOACs for six months one at the time. Receives: Drug: Dabigatran Etexilate Oral Capsule; Drug: Rivaroxaban Oral Tablet; Drug: Edoxaban Oral Tablet; Drug: Apixaban Oral Tablet |
| Edoxaban | Active comparator | After randomization, the cluster will use edoxaban to all their patients with non-valvular atrial fibrillation when possible for six months. Hereafter the cluster will use the other three NOACs for six months one at the time. Receives: Drug: Dabigatran Etexilate Oral Capsule; Drug: Rivaroxaban Oral Tablet; Drug: Edoxaban Oral Tablet; Drug: Apixaban Oral Tablet |
| Apixaban | Active comparator | After randomization, the cluster will use apixaban to all their patients with non-valvular atrial fibrillation when possible for six months. Hereafter the cluster will use the other three NOACs for six months one at the time. Receives: Drug: Dabigatran Etexilate Oral Capsule; Drug: Rivaroxaban Oral Tablet; Drug: Edoxaban Oral Tablet; Drug: Apixaban Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy outcome: A composite endpoint of stroke, myocardial infarction, thromboembolic event or all-cause death.
First occurrence of stroke, myocardial infarction, thromboembolic event or all-cause death.
Information of endpoints and comorbidity is obtained from the Danish National Patient Register based on ICD-10 diagnostic codes and information of vital status and date of death will be obtained from the Central Person Register. Information of prescribed drug will be obtained using information from the Danish Registry of Medicinal Product Statistics.
Measured: 2 years.
Secondary outcomes (5)
Primary safety outcome: bleeding requiring hospitalization.
First occurrence of bleeding requiring hospitalization. Information of endpoints and comorbidity is obtained from the Danish National Patient Register based on ICD-10 diagnostic codes and information of vital status and date of death will be obtained from the Central Person Register. Information of prescribed drug will be obtained using information from the Danish Registry of Medicinal Product Statistics.
Measured: 2 years.
Secondary efficacy outcome: Stroke
Information of endpoints and comorbidity is obtained from the Danish National Patient Register based on ICD-10 diagnostic codes and information of vital status and date of death will be obtained from the Central Person Register. Information of prescribed drug will be obtained using information from the Danish Registry of Medicinal Product Statistics.
Measured: 2 years.
Secondary efficacy outcome: Myocardial infarction.
Information of endpoints and comorbidity is obtained from the Danish National Patient Register based on ICD-10 diagnostic codes and information of vital status and date of death will be obtained from the Central Person Register. Information of prescribed drug will be obtained using information from the Danish Registry of Medicinal Product Statistics.
Measured: 2 years.
Secondary efficacy outcome: Thromboembolic event.
Information of endpoints and comorbidity is obtained from the Danish National Patient Register based on ICD-10 diagnostic codes and information of vital status and date of death will be obtained from the Central Person Register. Information of prescribed drug will be obtained using information from the Danish Registry of Medicinal Product Statistics.
Measured: 2 years.
Secondary efficacy outcome: All-cause death.
Information of endpoints and comorbidity is obtained from the Danish National Patient Register based on ICD-10 diagnostic codes and information of vital status and date of death will be obtained from the Central Person Register. Information of prescribed drug will be obtained using information from the Danish Registry of Medicinal Product Statistics.
Measured: 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start1 Apr 2023
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Cluster randomized cross-over study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 11,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gunnar Gislason, Herlev and Gentofte Hospital
- Investigators
- Gunnar H Gislason, MD, PhD, Study chair, Danish Heart Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03129490
- Sponsor's protocol ID
- DHF1
- Acronym
- DANNOAC-AF
- Status last verified
- May 2025
- First submitted
- 18 Apr 2017
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Danish Non-vitamin K Antagonist Oral Anticoagulation Study. A Cluster Randomized Study Comparing Safety and Efficacy of Edoxaban, Apixaban, Rivaroxaban and Dabigatran for Oral Anticoagulation in Atrial Fibrillation (DANNOAC-AF).
- ClinicalTrials.gov ID
- NCT03129490
- Acronym / sponsor ID
- DANNOAC-AF / DHF1
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Keywords
- Atrial Fibrillation, Non-vitamin K antagonist oral anticoagulation, Direct-acting oral anticoagulants, Novel oral anticoagulant drugs, Non-vitamin K antagonist oral anticoagulants, Atrial Flutter
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 11,000 participants (estimated)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 26 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
No randomized head-to-head comparison between the individual Non-vitamin K Antagonist Oral Anticoagulants (NOAC) exists. The DANNOAC-AF study is a nationwide cluster randomized cross-over study comparing efficacy and safety of the four NOACs, edoxaban, apixaban, rivaroxaban and dabigatran for oral anticoagulation in atrial fibrillation and atrial flutter across Danish hospitals and cardiology clinics.
Detailed description
No randomized head-to-head comparison between the individual Non-vitamin K Antagonist Oral Anticoagulants (NOAC) exists, but such data are warranted to evaluate if the four NOACs are equal in stroke prevention without an additional cost of increased bleeding risk. Furthermore, classic randomized trials are highly selective, as elderly and/or fragile patients and patients with comorbidity are underrepresented. Therefore, there is a need of randomized trials that include a broader population of patients.
The DANNOAC-AF study is a nationwide cluster randomized cross-over study comparing efficacy and safety of the four NOACs, edoxaban, apixaban, rivaroxaban and dabigatran for oral anticoagulation in non-valvular atrial fibrillation and atrial flutter across Danish hospitals and cardiology clinics. The aim of the present study is to: 1) examine if the four NOACs are equally effective in preventing strokes, death and hospitalizations without increasing the risk of major bleeding requiring hospitalization; 2) conduct a randomized study that includes elderly and fragile patients and patients with comorbidity that would otherwise not be included in a traditional randomized clinical trial.
For a variety of reasons, Danish hospitals and clinicians often prefer one particular NOAC. This can make work simpler for the busy clinician, although there may also be economic advantages on a local or a regional larger scale. For a period of two years, this study will replace this individually preferred selection with a random selection. The hospitals and clinics that participate in this study will be randomly selected to primarily use one specific NOAC for 6 months at a time during a total period of two years. This only applies to patients with non-valvular atrial fibrillation or atrial flutter that are selected by the physician to be eligible for NOAC treatment.
Endpoints
- Primary efficacy outcome: a composite endpoint of stroke, myocardial infarction, thromboembolic event or all-cause death.
- Secondary efficacy outcomes: Individually components of the primary endpoints; stroke, myocardial infarction, thromboembolism or all-cause death.
- Primary safety outcome: bleeding requiring hospitalization.
- Other effect measures:
- discontinuation of therapy.
- adherence to therapy.
- other reasons of admission to hospital than included in the primary and secondary endpoint.
- Sensitivity analyses:
- primary endpoint stratified by gender.
- primary endpoint stratified by age (≤65, 65-75, >75 years of age).
- primary endpoint stratified by levels of the CHA2DS2VASc score (0-1, 2-3, >3).
- primary endpoint with exclusion of clusters with non-compliance greater than 20% of cluster randomization.
- primary endpoint where the actual treatment is used instead of the allocated treatment.
- primary safety endpoint stratified by HAS-BLED score.
Information of endpoints and comorbidity is obtained from the Danish National Patient Register based on ICD-10 diagnostic codes and information of vital status and date of death will be obtained from the Central Person Register. Drug discontinuation and adherence will be examined using information from the Danish Registry of Medicinal Product Statistics. The prespecified endpoints will be evaluated after 2 years as intention-to-treat analysis. In addition, the prespecified endpoints will be evaluated after 5 and 10 years.
A cluster is defined as a hospital or a cardiology clinic. the clusters will be initiated in the study from 1. of April 2023 to 1. October 2023.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Cluster randomized cross-over study.
| Arm | Type | Receives |
|---|---|---|
| Dabigatran | Active comparator | Drug: Dabigatran Etexilate Oral Capsule, Drug: Rivaroxaban Oral Tablet, Drug: Edoxaban Oral Tablet, Drug: Apixaban Oral TabletAfter randomization, the cluster will use dabigatran to all their patients with non-valvular atrial fibrillation when possible for six months. Hereafter the cluster will use the other three NOACs for six months one at the time. |
| Rivaroxaban | Active comparator | Drug: Dabigatran Etexilate Oral Capsule, Drug: Rivaroxaban Oral Tablet, Drug: Edoxaban Oral Tablet, Drug: Apixaban Oral TabletAfter randomization, the cluster will use rivaroxaban to all their patients with non-valvular atrial fibrillation when possible for six months. Hereafter the cluster will use the other three NOACs for six months one at the time. |
| Edoxaban | Active comparator | Drug: Dabigatran Etexilate Oral Capsule, Drug: Rivaroxaban Oral Tablet, Drug: Edoxaban Oral Tablet, Drug: Apixaban Oral TabletAfter randomization, the cluster will use edoxaban to all their patients with non-valvular atrial fibrillation when possible for six months. Hereafter the cluster will use the other three NOACs for six months one at the time. |
| Apixaban | Active comparator | Drug: Dabigatran Etexilate Oral Capsule, Drug: Rivaroxaban Oral Tablet, Drug: Edoxaban Oral Tablet, Drug: Apixaban Oral TabletAfter randomization, the cluster will use apixaban to all their patients with non-valvular atrial fibrillation when possible for six months. Hereafter the cluster will use the other three NOACs for six months one at the time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A diagnosis of atrial fibrillation or atrial flutter in outpatient clinic or as discharge diagnosis after hospitalization.
- A claimed prescription of a NOAC from a Danish pharmacy within 14 days of discharge or outpatient clinic visit.
Key exclusion criteria (1 listed)
- A prescription of a NOAC within 90 days prior to hospitalization or outpatient clinic visit for atrial fibrillation 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 |
|---|---|---|
| Dabigatran Etexilate Oral CapsuleAfter cluster randomization, the cluster will use dabigatran to all their patients with non-valvular atrial fibrillation when possible for six months. Hereafter the cluster will use the other three NOACs for six months one at the time. It is the clusters and not the patient that are randomized. | Drug | Apixaban, Dabigatran, Edoxaban, Rivaroxaban |
| Rivaroxaban Oral TabletAfter cluster randomization, the cluster will use rivaroxaban to all their patients with non-valvular atrial fibrillation when possible for six months. Hereafter the cluster will use the other three NOACs for six months one at the time. It is the clusters and not the patient that are randomized. | Drug | Apixaban, Dabigatran, Edoxaban, Rivaroxaban |
| Edoxaban Oral TabletAfter cluster randomization, the cluster will use edoxaban to all their patients with non-valvular atrial fibrillation when possible for six months. Hereafter the cluster will use the other three NOACs for six months one at the time. It is the clusters and not the patient that are randomized. | Drug | Apixaban, Dabigatran, Edoxaban, Rivaroxaban |
| Apixaban Oral TabletAfter cluster randomization, the cluster will use apixaban to all their patients with non-valvular atrial fibrillation when possible for six months. Hereafter the cluster will use the other three NOACs for six months one at the time. It is the clusters and not the patient that are randomized. | Drug | Apixaban, Dabigatran, Edoxaban, Rivaroxaban |
Primary outcome
Primary efficacy outcome: A composite endpoint of stroke, myocardial infarction, thromboembolic event or all-cause death.
Time frame: 2 years.
First occurrence of stroke, myocardial infarction, thromboembolic event or all-cause death. Information of endpoints and comorbidity is obtained from the Danish National Patient Register based on ICD-10 diagnostic codes and information of vital status and date of death will be obtained from the Central Person Register. Information of prescribed drug will be obtained using information from the Danish Registry of Medicinal Product Statistics.
5 secondary outcomes
Primary safety outcome: bleeding requiring hospitalization.
Time frame: 2 years.
Secondary efficacy outcome: Stroke
Time frame: 2 years.
Secondary efficacy outcome: Myocardial infarction.
Time frame: 2 years.
Secondary efficacy outcome: Thromboembolic event.
Time frame: 2 years.
Secondary efficacy outcome: All-cause death.
Time frame: 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- DANNOAC study webpageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Gunnar H Gislason, MD, PhD study chair
Danish Heart Foundation
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dabigatran Etexilate Oral Capsule, Rivaroxaban Oral Tablet and Edoxaban Oral Tablet in people with Atrial Fibrillation and Atrial Flutter, run by Herlev and Gentofte Hospital at 38 sites in Denmark.
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 2 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in Denmark. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Primary efficacy outcome: A composite endpoint of stroke, myocardial infarction, thromboembolic event or all-cause death. (time frame: 2 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2025.