Stroke Prophylaxis of AF-patients: Real-life Effectiveness and Safety of Novel Anticoagulants Compared to VKA
Stroke Prophylaxis of Patients With Atrial Fibrillation: Real-life Effectiveness and Safety of Novel Anticoagulants Compared to Vitamin-k-antagonists Based on an Analysis of German Claims Data
The central questions of the study can be summarized as follows:
What stroke / death rates are the result of the use of the following treatment strategies: no anticoagulation with vitamin-k-antagonists (VKAs) or novel oral anticoagulants (NOACs), anticoagulation with VKAs and anticoagulation with NOACs (all). What other thromboembolic complication rates resulting from the use of these treatment strategies? What heavy bleeding rates resulting from the defined management strategies? The analysis is based on a data set of patients with atrial fibrillation (AF)(01/01/2010 - 30/06/2014). 2010 is used as the reference period and 01/01/2011-30/06/2013 as the inclusion period. The minimum observation time per patient is 12 months.
Used is a data base of the AOK PLUS as well as the AOK Baden-Württemberg and AOK Bayern.
The aim of the study is to compare clinical outcomes between the different treatment strategies (frequency of events and time to first event). The influence of alternative treatment strategies is measured on the basis of three different methodological approaches: unadjusted comparison of event council and time to first event between the defined patient groups; matched-pair comparison (propensity score matching) between the different groups of patients (treatment strategies) and multivariate analysis using time to event (Cox proportional hazards model) as the dependent variable.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- one inpatient or two outpatient confirmed diagnosis of atrial fibrillation in two different quarters
- Continuously insured by the AOK PLUS, AOK Bayern or AOK Baden-Württemberg
Exclusion Criteria:
- Age < 18 years
- Maximum possible observational period < 12 months (exception: death)
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
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No anticoagulation with VKA/NOAC
No prescriptions of vitamin-k-antagonists/novel anticoagulants in all observational period; No prescriptions of low molecular weight heparins/Clopidogrel during observation period to the extent of more than 30 days.
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Anticoagulation with vitamin-k-antagonists
The patient should be treated stable during the observation period with vitamin-k-antagonists (at least one prescription per half-year).
The patient should be not been around on other anticoagulants during the observation period.
This means that no prescriptions of novel anticoagulants and not more than 30 days should be observable prescriptions of low molecular weight heparins/Clopidogrel per year.
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Anticoagulation with novel oral anticoagulants
The patient should be treated stable during the observation period with a novel anticoagulant (at least one prescription per half-year).
This means that no vitamin-k-antagonists prescriptions and not more than 30 days should be observable prescriptions of low molecular weight heparins/Clopidogrel per year from the start of the observation period.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Death
Tidsram: 01/01/2011-30/06/2014; at least 12 months; up to 40 months
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01/01/2011-30/06/2014; at least 12 months; up to 40 months
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Transient ischemic attack
Tidsram: 01/01/2011-30/06/2014; at least 12 months; up to 40 months
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01/01/2011-30/06/2014; at least 12 months; up to 40 months
|
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Ischemic stroke
Tidsram: 01/01/2011-30/06/2014; at least 12 months; up to 40 months
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01/01/2011-30/06/2014; at least 12 months; up to 40 months
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Hemorrhagic stroke
Tidsram: 01/01/2011-30/06/2014; at least 12 months; up to 40 months
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01/01/2011-30/06/2014; at least 12 months; up to 40 months
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Heavy bleeding
Tidsram: 01/01/2011-30/06/2014; at least 12 months; up to 40 months
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01/01/2011-30/06/2014; at least 12 months; up to 40 months
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Samarbetspartners och utredare
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Hjärtsjukdom
- Hjärt-kärlsjukdomar
- Kärlsjukdomar
- Cerebrovaskulära störningar
- Hjärnsjukdomar
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- Arytmier, hjärt
- Stroke
- Förmaksflimmer
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Fibrinmodulerande medel
- Mikronäringsämnen
- Vitaminer
- Antifibrinolytiska medel
- Hemostatika
- Koagulanter
- Vitamin K
- Antikoagulantia
Andra studie-ID-nummer
- NOAC001
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