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Goede Antistolling In Noord Nederland: Vergelijking tussen vitamine K antagonisten (VKA) en nieuwe orale anticoagulantia in patienten met boezemfibrilleren die het nu goed doen op VKA antagonisten en Nieuwe Orale anticoagulantia in patienten die momenteel goed ingesteld zijn op een vitamine K antagonist.


- candidate number19395
- NTR NumberNTR4770
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-sep-2014
- Secondary IDsMETc 2014/002 Medisch Ethische Toetsingscommissie UMCG
- Public TitleGoede Antistolling In Noord Nederland: Vergelijking tussen vitamine K antagonisten (VKA) en nieuwe orale anticoagulantia in patienten met boezemfibrilleren die het nu goed doen op VKA antagonisten en Nieuwe Orale anticoagulantia in patienten die momenteel goed ingesteld zijn op een vitamine K antagonist.
- Scientific TitleVitamin K antagonists (VKA) versus New Oral Anticoagulants (NOACs) in patients with currently well controlled VKA therapy for non-valvular atrial fibrillation: a pilot study.
- ACRONYMGAInN
- hypothesisIn 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
- Healt Condition(s) or Problem(s) studiedAtrial Fibrillation, Vitamin K antagonist, New Oral Anticoagulants (NOAC)
- 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2014
- planned closingdate17-nov-2017
- Target number of participants240
- InterventionsPatients 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.
- Primary outcomeNet 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
- TimepointsPrimary and secondary outcomes, timpoint: 1 year
- Trial web sitewww.hematologiegroningen.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIES Jasper (J.H.A.) van Miert
- CONTACT for SCIENTIFIC QUERIES Jasper (J.H.A.) van Miert
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG), Certe Thrombosis Service Groningen
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD4-sep-2014 - 4-nov-2017


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