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The Safety and Effectiveness of Warfarin and Dabigatran Prescribed in the Non-Valvular Atrial Fibrillation Population With DoD Healthcare Coverage

2015年7月1日 更新者：Boehringer Ingelheim

The Comparative Safety and Effectiveness of Warfarin and Dabigatran Utilized in the Department of Defense (DoD) Non-Valvular Atrial Fibrillation (NVAF) Patient Population-A Retrospective Database Analysis

The objective is to assess the safety and effectiveness of new dabigatran and warfarin patients diagnosed with NVAF in the US DoD population.

調査の概要

状態

完了

条件

詳細な説明

Study Design:

Retrospective

研究の種類

観察的

入学 (実際)

25586

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Massachusetts
      • Lexington、Massachusetts、アメリカ
        • 1160.183.01 Boehringer Ingelheim Investigational Site

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

NVAF

説明

Inclusion criteria:

  • Patients must be continuously enrolled in a health plan during the pre-index period;
  • Patients must have at least one inpatient, or one physician office visit, emergency room visit with a diagnosis of AF (ICD-9-CM diagnosis code: 427.31in any position) on the index date or during the pre-index period;
  • Patients must have a prescription for dabigatran or warfarin (this first prescription will be the index date);
  • Patients must be treatment naive from all OAC use prior to first dabigatran or warfarin prescription;
  • Aged 18-89 on the index date;

Exclusion criteria:

  • Patients with valvular procedures related to the baseline AF diagnosis will be excluded;
  • Patients with transient causes of AF such as hyperthyroidism, any cardiac surgery, pericarditis, mycoarditis, pulmonary embolism within 3 months prior to their first diagnosis of AF;

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 時間の展望：回顧

コホートと介入

グループ/コホート
ダビガトラン
ワルファリン

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
メジャーの説明
時間枠
Stroke (Hemorrhagic, Ischemic)
時間枠：From October 1, 2009 through July 31, 2013 (the study period)

Event rate of stroke (hemorrhagic, ischemic).

Variables in the final propensity score model: age, gender index year, baseline CHADS(2) score (Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, Prior Stroke or transient ischemic attack (TIA) or Thromboembolism), baseline CHA(2)DS(2)-VASc score (Congestive heart failure, Hypertension, Age ≥75 years (doubled), Diabetes mellitus, Stroke (doubled), Vascular disease, Age 65-74 years, Sex category), baseline HAS-BLED score (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile International Normalized Ratio, Elderly, Drugs/alcohol concomitantly), baseline use of several medications and presence of several baseline co-morbidities.

The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
From October 1, 2009 through July 31, 2013 (the study period)
Major Bleeding
時間枠：From October 1, 2009 through July 31, 2013 (the study period)

Event rate of major bleeding.

The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
From October 1, 2009 through July 31, 2013 (the study period)

二次結果の測定

結果測定
メジャーの説明
時間枠
Ischemic Stroke
時間枠：From October 1, 2009 through July 31, 2013 (the study period)

Event rate of ischemic stroke.

The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
From October 1, 2009 through July 31, 2013 (the study period)
Hemorrhagic Stroke
時間枠：From October 1, 2009 through July 31, 2013 (the study period).

Event rate of hemorrhagic stroke.

The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
From October 1, 2009 through July 31, 2013 (the study period).
Major Intracranial Bleeding
時間枠：From October 1, 2009 through July 31, 2013 (the study period).

Event rate of major intracranial bleeding.

The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
From October 1, 2009 through July 31, 2013 (the study period).
Major Extracranial Bleeding
時間枠：From October 1, 2009 through July 31, 2013 (the study period).

Event rate of major extracranial bleeding.

The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
From October 1, 2009 through July 31, 2013 (the study period).
Major GI Bleeding
時間枠：From October 1, 2009 through July 31, 2013 (the study period).

Event rate of major gastrointestinal (GI) bleeding.

The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
From October 1, 2009 through July 31, 2013 (the study period).
Major Upper GI Bleeding
時間枠：From October 1, 2009 through July 31, 2013 (the study period).

Event rate of major upper gastrointestinal (GI) bleeding.

The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
From October 1, 2009 through July 31, 2013 (the study period).
Major Lower GI Bleeding
時間枠：From October 1, 2009 through July 31, 2013 (the study period).

Event rate of major lower gastrointestinal (GI) bleeding.

The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
From October 1, 2009 through July 31, 2013 (the study period).
Major Urogenital Bleeding
時間枠：From October 1, 2009 through July 31, 2013 (the study period).

Event rate of major urogenital bleeding.

The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
From October 1, 2009 through July 31, 2013 (the study period).
Major Other Bleeding
時間枠：From October 1, 2009 through July 31, 2013 (the study period).

Event rate of major other bleeding.

The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
From October 1, 2009 through July 31, 2013 (the study period).
Transient Ischemic Attack
時間枠：From October 1, 2009 through July 31, 2013 (the study period).

Event rate of transient ischemic attacks.

The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
From October 1, 2009 through July 31, 2013 (the study period).
Myocardial Infarction
時間枠：From October 1, 2009 through July 31, 2013 (the study period).

Event rate of myocardial infarction.

The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
From October 1, 2009 through July 31, 2013 (the study period).
Venous Thromboembolism
時間枠：From October 1, 2009 through July 31, 2013 (the study period).

Event rate of venous thromboembolism.

The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
From October 1, 2009 through July 31, 2013 (the study period).
Deep Vein Thrombosis
時間枠：From October 1, 2009 through July 31, 2013 (the study period).

Event rate of deep vein thrombosis.

The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
From October 1, 2009 through July 31, 2013 (the study period).
Pulmonary Embolism
時間枠：From October 1, 2009 through July 31, 2013 (the study period).

Event rate of pulmonary embolism.

The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
From October 1, 2009 through July 31, 2013 (the study period).
Death
時間枠：From October 1, 2009 through July 31, 2013 (the study period).

Event rate of death, due to any cause.

The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
From October 1, 2009 through July 31, 2013 (the study period).

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Boehringer Ingelheim

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2014年1月1日

一次修了 (実際)

2014年5月1日

研究の完了 (実際)

2014年5月1日

試験登録日

最初に提出

2014年1月10日

QC基準を満たした最初の提出物

2014年1月21日

最初の投稿 (見積もり)

2014年1月23日

学習記録の更新

投稿された最後の更新 (見積もり)

2015年7月3日

QC基準を満たした最後の更新が送信されました

2015年7月1日

最終確認日

2015年7月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 1160.183

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