The Danish Non-vitamin K Antagonist Oral Anticoagulation Study in Patients With Atrial Fibrillation
DANNOAC-AF
1 other identifier
interventional
11,000
1 country
38
Brief 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 atrial fibrillation and atrial flutter across Danish hospitals and cardiology clinics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 atrial-fibrillation
Started Apr 2023
Typical duration for phase_4 atrial-fibrillation
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2017
CompletedFirst Posted
Study publicly available on registry
April 26, 2017
CompletedStudy Start
First participant enrolled
April 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 30, 2027
May 18, 2025
May 1, 2025
4.6 years
April 18, 2017
May 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
2 years.
Secondary Outcomes (5)
Primary safety outcome: bleeding requiring hospitalization.
2 years.
Secondary efficacy outcome: Stroke
2 years.
Secondary efficacy outcome: Myocardial infarction.
2 years.
Secondary efficacy outcome: Thromboembolic event.
2 years.
Secondary efficacy outcome: All-cause death.
2 years.
Other Outcomes (2)
Discontinuation of therapy
2 years
Adherence to therapy.
2 years
Study Arms (4)
Dabigatran
ACTIVE COMPARATORAfter 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 COMPARATORAfter 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 COMPARATORAfter 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 COMPARATORAfter 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.
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- A prescription of a NOAC within 90 days prior to hospitalization or outpatient clinic visit for atrial fibrillation or atrial flutter.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
Hjerteklinik Nordjylland
Aalborg, Denmark
Aarhus University Hospital
Aarhus, 8200, Denmark
Hjertelægerne i Ballerup
Ballerup Municipality, 2750, Denmark
Hjertelæge Christian Lange
Copenhagen, 1264, Denmark
Bispebjerg Hospital - Department of Geriatrics
Copenhagen, Denmark
Hjerteklinikken Amaliegade
Copenhagen, Denmark
Hjerteklinikken ved Speciallæge Anders Galløe
Copenhagen, Denmark
Bispebjerg Hospital - Department of Neurology
Copenhagen NV, 2400, Denmark
Amager Hospital
Copenhagen S, 2300, Denmark
Hjerteklinik Østerbro I/S
Copenhagen Ø, 2100, Denmark
Rigshospitalet
Copenhagen Ø, 2100, Denmark
Esbjerg Hospital
Esbjerg, 6700, Denmark
Bispebjerg and Frederiksberg Hospital - Department of Cardiology
Frederiksberg, 2000, Denmark
Frederiksberg Hjerteklinik
Frederiksberg, 2000, Denmark
Nordsjællands Hospital - Frederiksund
Frederikssund, 3600, Denmark
Gentofte Hospital
Gentofte Municipality, 2900, Denmark
Glostrup Hospital - Department of Emergency Medicine
Glostrup Municipality, 2600, Denmark
Glostrup Hospital - Department of Medicine / Cardiology
Glostrup Municipality, 2600, Denmark
Glostrup Hospital - Department of Neurology
Glostrup Municipality, 2600, Denmark
Herlev-Gentofte Hospital - Department of Medicine
Herlev, 2730, Denmark
Hjertelægerne i Hillerød
Hillerød, 3400, Denmark
Nordsjællands Hospital - Hillerød
Hillerød, 3400, Denmark
Hjørring Hospital
Hjørring, 9800, Denmark
Holbæk Hospital
Holbæk, 4300, Denmark
Speciallæge Michael Dilou Jacobsen
Holte, 2840, Denmark
Hvidovre Hospital
Hvidovre, 2650, Denmark
Næstved Hospital
Næstved, 4700, Denmark
Odense University Hospital - Department of Cardiology
Odense, 5000, Denmark
Odense University Hospital - Department of Emergency Medicine
Odense, 5000, Denmark
Odense University Hospital - Department of Geriatrics
Odense, 5000, Denmark
Odense University Hospital - Department of Neurology
Odense, 5000, Denmark
Zealand University Hospital - Department of Neurology
Roskilde, 4000, Denmark
Zealand University Hospital Roskilde - Department of Cardiology
Roskilde, 4000, Denmark
Bornholms Hospital
Rønne, 3700, Denmark
Slagelse Hospital
Slagelse, 4200, Denmark
Odense University Hospital Svendborg
Svendborg, 5700, Denmark
Klinik Hjertesund
Taastrup, 2630, Denmark
Vejle Hospital
Vejle, 7100, Denmark
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Gunnar H Gislason, MD, PhD
Danish Heart Foundation
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Open label
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
April 18, 2017
First Posted
April 26, 2017
Study Start
April 1, 2023
Primary Completion (Estimated)
October 30, 2027
Study Completion (Estimated)
October 30, 2027
Last Updated
May 18, 2025
Record last verified: 2025-05