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National register of patients with atrial fibrillation - DUTCH-AF Registry

DUTCH-AF Registry – Prospective evaluation of dosing and adherence of anticoagulant treatment and the risk for bleeding in atrial fibrillation

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON19961
Enrollment
6000
Registered
2018-11-29
Start date
2018-07-01
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

Atrial fibrillation, Atriumfibrilleren, Therapy adherence, Therapietrouw, NOAC, DOAC

Interventions

None

Sponsors

Leiden University Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. New-onset or recent history of atrial fibrillation, documented as: - 12-lead ECG, or - Holter recording (duration >= 30 seconds), or - Loop recorder or device detected Atrial High-Rate Episode of at least 24 hours 2. Age >= 18 years 3. Able and willing to sign informed consent for the registry

Exclusion criteria

Exclusion criteria: 1. Mechanical heart valve or moderate-to-severe mitral stenosis 2. Life expectancy < 6 months 3. Atrial fibrillation following cardiothoracic surgery within 14 days

Design outcomes

Primary

MeasureTime frame
Investigate how daily use (dosing, adherence and persistence) of anticoagulants in patients with NVAF is related to the risk of ischemic stroke, major and clinically relevant non-major bleeding, and (cardiovascular) death.

Secondary

MeasureTime frame
1) determine which patient, doctor and practice characteristics are related to improper use /non-adherence and develop a tool to predict therapy non-adherence and persistence 2) validate and refine an existing bleeding model for NOAC and VKA users and define modifiable risk factors for bleeding.

Contacts

Public ContactM.V. Huisman

Leiden University Medical Center (LUMC) Department of Thrombosis and Haemostasis Room C4-68 P.O Box 9600

m.v.huisman@lumc.nl+31 (0)71 5262085

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)