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Stroke Prophylaxis of AF-patients: Real-life Effectiveness and Safety of Novel Anticoagulants Compared to VKA

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ClinicalTrials.gov Identifier: NCT02657616
Recruitment Status : Completed
First Posted : January 18, 2016
Last Update Posted : January 18, 2016
Sponsor:
Information provided by (Responsible Party):
Sabrina Müller, Institut für Pharmakoökonomie und Arzneimittellogistik e.V.

Brief Summary:

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.


Condition or disease Intervention/treatment
Atrial Fibrillation Stroke Prophylaxis Drug: vitamin-k-antagonists Drug: Novel oral anticoagulants

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Study Type : Observational
Actual Enrollment : 204464 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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
Study Start Date : December 2015
Actual Primary Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Menadione

Group/Cohort Intervention/treatment
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.
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.
Drug: vitamin-k-antagonists
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.
Drug: Novel oral anticoagulants



Primary Outcome Measures :
  1. Death [ Time Frame: 01/01/2011-30/06/2014; at least 12 months; up to 40 months ]
  2. Transient ischemic attack [ Time Frame: 01/01/2011-30/06/2014; at least 12 months; up to 40 months ]
  3. Ischemic stroke [ Time Frame: 01/01/2011-30/06/2014; at least 12 months; up to 40 months ]
  4. Hemorrhagic stroke [ Time Frame: 01/01/2011-30/06/2014; at least 12 months; up to 40 months ]
  5. Heavy bleeding [ Time Frame: 01/01/2011-30/06/2014; at least 12 months; up to 40 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The analysis is based on a data set of patients with atrial fibrillation (01/01/2010 - 30/06/2014) insured by the AOK PLUS, AOK Bayern or AOK Baden-Württemberg.
Criteria

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)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sabrina Müller, Principal investigator, Institut für Pharmakoökonomie und Arzneimittellogistik e.V.
ClinicalTrials.gov Identifier: NCT02657616     History of Changes
Other Study ID Numbers: NOAC001
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: January 18, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
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Stroke
Atrial Fibrillation
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Vitamins
Vitamin K
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Fibrinolytic Agents