No registrations found.
ID
Source
Brief title
Health condition
Non-valvular atrial fibrillation
Vitamin K antagonists
New Oral Anticoagulants
Sponsors and support
- Certe Thrombosis Service Groningen
Intervention
Outcome measures
Primary outcome
Net clinical benefit: composite of stroke, systemic embolism, myocardial infarction, vascular death and major bleeds. All components will also individually be assessed.
Secondary outcome
- Efficacy
- Safety
- Burden of complications
- Treatment expectations and satisfaction
- Compliance
- Quality of life
- Feasibility
Background summary
Vitamin K antagonists (VKA) versus New Oral Anticoagulants (NOACs) in patients with currently well controlled VKA therapy for non-valvular atrial fibrillation: a pilot study.
Study objective
In patients with previous adequate quality of VKA therapy, VKA therapy is superior to NOAC therapy, in terms of net clinical benefit as well as cost-effectiveness
Study design
Primary and secondary outcomes, timpoint: 1 year
Intervention
Patients randomized to receive VKA will continue their treatment according to usual care, managed by the Thrombosis Service using a therapeutic range of INR 2.0-3.5. Patients randomized to NOAC therapy will be instructed on the use of NOACs, and followed as per usual care.
Inclusion criteria
-Men or women aged >= 18 years who are currently treated with VKA for non-valvular atrial fibrillation, managed by the Groningen Thrombosis Service.
-A minimum duration of 6 months of VKA treatment at the time of selection by the Thrombosis Service.
- An individual Time in Therapeutic Range (iTTR) >= 70% over the 4 months of VKA treatment before selection by the Thrombosis Service.
Exclusion criteria
-A thrombo-embolic event or major bleeding ever while on VKA.
-Indication for anticoagulation other than atrial fibrillation.
-Contra-indication to receive any kind of NOAC.
-Life expectancy <1 year.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4619 |
| NTR-old | NTR4770 |
| Other | Medisch Ethische Toetsingscommissie UMCG : METc 2014/002 |