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.
調査の概要
研究の種類
入学 (実際)
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
|
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Death
時間枠：01/01/2011-30/06/2014; at least 12 months; up to 40 months
|
01/01/2011-30/06/2014; at least 12 months; up to 40 months
|
|
Transient ischemic attack
時間枠：01/01/2011-30/06/2014; at least 12 months; up to 40 months
|
01/01/2011-30/06/2014; at least 12 months; up to 40 months
|
|
Ischemic stroke
時間枠：01/01/2011-30/06/2014; at least 12 months; up to 40 months
|
01/01/2011-30/06/2014; at least 12 months; up to 40 months
|
|
Hemorrhagic stroke
時間枠：01/01/2011-30/06/2014; at least 12 months; up to 40 months
|
01/01/2011-30/06/2014; at least 12 months; up to 40 months
|
|
Heavy bleeding
時間枠：01/01/2011-30/06/2014; at least 12 months; up to 40 months
|
01/01/2011-30/06/2014; at least 12 months; up to 40 months
|
協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
vitamin-k-antagonistsの臨床試験
-
Kallyope Inc.募集
-
CSA Medical, Inc.終了しました