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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.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28322
Enrollment
240
Registered
2014-09-04
Start date
2014-11-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-valvular atrial fibrillation Vitamin K antagonists New Oral Anticoagulants

Interventions

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 therap

Sponsors

University Medical Centre Groningen
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
Net clinical benefit: composite of stroke, systemic embolism, myocardial infarction, vascular death and major bleeds. All components will also individually be assessed.

Secondary

MeasureTime frame
- Efficacy - Safety - Burden of complications - Treatment expectations and satisfaction - Compliance - Quality of life - Feasibility

Contacts

Public ContactJasper (J.H.A.) van Miert

UMCG

j.h.a.van.miert@umcg.nl+31503610225

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)