The Danish Non-vitamin K Antagonist Oral Anticoagulation Study in Patients With Venous Thromboembolism (DANNOAC-VTE)
DANNOAC-VTE
1 other identifier
interventional
5,000
1 country
26
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2023
Longer than P75 for phase_4
26 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
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2029
May 15, 2025
May 1, 2025
4 years
April 18, 2017
May 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary efficacy outcome: a composite endpoint of new venous thromboembolism or all-cause death.
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.
6 months.
Secondary Outcomes (3)
Secondary efficacy outcome: New venous thromboembolism.
6 months.
Secondary efficacy outcome: All-cause death.
6 months.
Primary safety outcome: bleeding requiring hospitalization.
6 months.
Other Outcomes (2)
Discontinuation of therapy.
6 months.
Adherence to therapy.
6 months.
Study Arms (4)
Dabigatran
ACTIVE COMPARATORAfter 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.
Rivaroxaban
ACTIVE COMPARATORAfter 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.
Edoxaban
ACTIVE COMPARATORAfter 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.
Apixaban
ACTIVE COMPARATORAfter 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.
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Aarhus University Hospital
Aarhus, 8200, Denmark
Bispebjerg and Frederiksberg Hospital
Copenhagen, 2400, Denmark
Bispebjerg Hospital
Copenhagen NV, 2400, Denmark
Amager Hospital
Copenhagen S, 2300, Denmark
Rigshospitalet
Copenhagen Ø, 2100, Denmark
Esbjerg Hospital
Esbjerg, 6700, Denmark
Nordsjællands Hospital - Frederiksund
Frederikssund, 3600, Denmark
Herlev 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
Nordsjællands Hospital - Hillerød
Hillerød, 3400, Denmark
Hjørring Hospital
Hjørring, 9800, Denmark
Holbæk Hospital
Holbæk, 4300, 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
Zealand University Hospital - Department of Neurology
Roskilde, 4000, Denmark
Zealand University Hospital Roskilde - Department of Cardiology
Roskilde, 4000, Denmark
Bornhoms Hospital
Rønne, 3700, Denmark
Slagelse Hospital
Slagelse, 4200, Denmark
Odense University Hospital Svendborg
Svendborg, 5700, 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
Herlev Gentofte Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The Outcome Assessor will only have a code of each drug and a code for each cluster. Therefore he will not know what drug the clusters have been using. The randomization key will be safely stored at servers at "Statens Serums Institute" (An institute under the Danish Ministry of Health). After the primary and secondary outcome have been evaluated data will be unblinded.
- Purpose
- TREATMENT
- 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)
March 31, 2027
Study Completion (Estimated)
March 31, 2029
Last Updated
May 15, 2025
Record last verified: 2025-05