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ACTIVE NOT RECRUITING
NCT03129555
PHASE4

The Danish Non-vitamin K Antagonist Oral Anticoagulation Study in Patients With Venous Thromboembolism (DANNOAC-VTE)

Sponsor: Herlev and Gentofte Hospital

View on ClinicalTrials.gov

Summary

No randomized head-to-head comparison between the individual Non-vitamin K Antagonist Oral Anticoagulants (NOAC) exists. The DANNOAC-VTE 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 venous thromboembolism across Danish hospitals.

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 Patients With Venous Thromboembolism.

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

5000

Start Date

2023-04-01

Completion Date

2029-03-31

Last Updated

2025-05-15

Healthy Volunteers

No

Interventions

DRUG

Dabigatran Etexilate Oral Capsule

After cluster randomization, the cluster will use dabigatran to all their patients with venous thromboembolism 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 venous thromboembolism 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 venous thromboembolism 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 venous thromboembolism 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.

Locations (26)

Aarhus University Hospital

Aarhus, Denmark

Bispebjerg and Frederiksberg Hospital

Copenhagen, Denmark

Bispebjerg Hospital

Copenhagen NV, Denmark

Amager Hospital

Copenhagen S, Denmark

Rigshospitalet

Copenhagen Ø, Denmark

Esbjerg Hospital

Esbjerg, Denmark

Nordsjællands Hospital - Frederiksund

Frederikssund, Denmark

Herlev Gentofte Hospital

Gentofte Municipality, Denmark

Glostrup Hospital - Department of Emergency Medicine

Glostrup Municipality, Denmark

Glostrup Hospital - Department of Medicine / Cardiology

Glostrup Municipality, Denmark

Glostrup Hospital - Department of Neurology

Glostrup Municipality, Denmark

Herlev-Gentofte Hospital - Department of Medicine

Herlev, Denmark

Nordsjællands Hospital - Hillerød

Hillerød, Denmark

Hjørring Hospital

Hjørring, Denmark

Holbæk Hospital

Holbæk, Denmark

Hvidovre Hospital

Hvidovre, Denmark

Næstved Hospital

Næstved, Denmark

Odense University Hospital - Department of Cardiology

Odense, Denmark

Odense University Hospital - Department of Emergency Medicine

Odense, Denmark

Odense University Hospital - Department of Geriatrics

Odense, Denmark

Zealand University Hospital - Department of Neurology

Roskilde, Denmark

Zealand University Hospital Roskilde - Department of Cardiology

Roskilde, Denmark

Bornhoms Hospital

Rønne, Denmark

Slagelse Hospital

Slagelse, Denmark

Odense University Hospital Svendborg

Svendborg, Denmark

Vejle Hospital

Vejle, Denmark