The Danish Non-vitamin K Antagonist Oral Anticoagulation Study in Patients With Atrial Fibrillation

Condition(s) studied

Investigational drug(s) / intervention(s)

Dabigatran Etexilate Oral Capsule: 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 Tablet: 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 Tablet: 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 Tablet: 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 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.

Eligibility

Primary outcome measure(s)

• Primary efficacy outcome: A composite endpoint of stroke, myocardial infarction, thromboembolic event or all-cause death. — 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.

Trial sites (38)

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