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

NCT03129490 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 11000

Last updated 2025-05-18

No results posted yet for this 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.

Conditions

Interventions

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • Herlev and Gentofte Hospital

    lead OTHER

Principal Investigators

  • Gunnar H Gislason, MD, PhD · Danish Heart Foundation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2027-10-30
Completion
2027-10-30

Countries

  • Denmark

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03129490 on ClinicalTrials.gov