The Danish Non-vitamin K Antagonist Oral Anticoagulation Study in Patients With Venous Thromboembolism (DANNOAC-VTE)
NCT03129555 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5000
Last updated 2025-05-15
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.
Conditions
- Deep Vein Thrombosis
- Pulmonary Embolism
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.
Sponsors & Collaborators
-
Herlev and Gentofte Hospital
lead OTHER
Principal Investigators
-
Gunnar H Gislason, MD, PhD · Herlev Gentofte Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- CROSSOVER
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-01
- Primary Completion
- 2027-03-31
- Completion
- 2029-03-31
Countries
- Denmark
Study Locations
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