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

NCT03129555 · tracked via the Priya Life Science Denmark tracker

Sponsor

Herlev and Gentofte Hospital

Phase

Phase 4

Started

2023-04-01

Last updated

2025-05-15

Condition(s) studied

Deep Vein ThrombosisPulmonary Embolism

Investigational drug(s) / intervention(s)

Dabigatran Etexilate Oral Capsule →Rivaroxaban Oral Tablet →Edoxaban Oral Tablet →Apixaban Oral Tablet →

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.

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.

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.

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.

Study 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.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

Inclusion Criteria: * A diagnosis of VTE 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. Exclusion Criteria: * A prescription of a NOAC within 90 days prior to hospitalization or outpatient clinic visit for VTE. * Patients with NOAC preference apart from preference consistent with current cluster randomized NOAC. * Other contraindications mentioned in the "Summary of Product Characteristics" for the respective NOAC.

Primary outcome measure(s)

Primary efficacy outcome: a composite endpoint of new venous thromboembolism or all-cause death. — 6 months.
First occurrence of new venous thromboembolism 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 (26)

Facility	City	Region
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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03129555 on ClinicalTrials.gov ↗ ← All trials in Denmark