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
ID
Bron
Verkorte titel
Aandoening
Non-valvular atrial fibrillation
Vitamin K antagonists
New Oral Anticoagulants
Ondersteuning
- Certe Thrombosis Service Groningen
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Net clinical benefit: composite of stroke, systemic embolism, myocardial infarction, vascular death and major bleeds. All components will also individually be assessed.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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
Onderzoeksopzet
Primary and secondary outcomes, timpoint: 1 year
Onderzoeksproduct en/of interventie
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.
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
-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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
-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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4619 |
| NTR-old | NTR4770 |
| Ander register | Medisch Ethische Toetsingscommissie UMCG : METc 2014/002 |