このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。英語版ソーステキスト用。

Non-Interventional Study on Effectiveness of Elxaban Tab. in Patients With Non-valvular Atrial Fibrillation

2020年1月15日更新者：Yonsei University

This study is prospective Cohort study which was performed in multicenter (General Hospital) in Korea. Inclusion criteria is patients with atrial fibrillation taking Elxaban (generic drug of apixaban) who visit hospital. The purpose is to analyze bleeding (major bleeding, minor bleeding), stroke, systemic embolism, death, other clinical events (acute myocardial infarction, pulmonary embolism, transient ischemic attack, hospitalization), drug adherence, questionnaire of life quality (AFEQT), cognitive function (KDSQ) according to the use of Elxaban.

調査の概要

状態

募集

条件

心房細動

研究の種類

観察的

入学 (予想される)

5000

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。

研究連絡先

名前：Boyoung Jung
電話番号：+82 02-2228-8447
メール：cby6908@yuhs.ac

研究場所

大韓民国
- - Seoul、大韓民国、03722
    - 募集
    - Division of Cardiology Severance Cardiovascular Hospital, Yonsei University College of Medicine
    - コンタクト：
      
      Boyoung Joung, M.D., Ph.D.
      
      電話番号：+82-2228-8447
      
      メール：CBY690@yuhs.ac

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

20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

Atrial fibrillatin patients taking Elxaban in general hospital

説明

Inclusion Criteria:

patients with atrial fibrillation taking Elxaban (patients with age more than 19)
Patients who agree with study inclusion

Exclusion Criteria:

patients who do not agree with study inclusion
patients with age less than 19
Pregnancy, Breastfeeding

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

グループ/コホートの数

コホートと介入

グループ/コホート
Elxaban group AF patients taking Elxaban

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
major bleeding 時間枠：1 month	Major bleeding is defined according to the criteria of the International Society on Thrombosis and Haemostasis (ISTH). Fatal bleeding, and/or Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or Bleeding causing a fall in hemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells.	1 month
major bleeding 時間枠：6 months	Major bleeding is defined according to the criteria of the International Society on Thrombosis and Haemostasis (ISTH). Fatal bleeding, and/or Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or Bleeding causing a fall in hemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells.	6 months
major bleeding 時間枠：12 months	Major bleeding is defined according to the criteria of the International Society on Thrombosis and Haemostasis (ISTH). Fatal bleeding, and/or Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or Bleeding causing a fall in hemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells.	12 months
major bleeding 時間枠：24 months	Major bleeding is defined according to the criteria of the International Society on Thrombosis and Haemostasis (ISTH). Fatal bleeding, and/or Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or Bleeding causing a fall in hemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells.	24 months
Stroke 時間枠：1 month	Stroke included both ischemic and hemorrhagic stroke.	1 month
Stroke 時間枠：6 months	Stroke included both ischemic and hemorrhagic stroke.	6 months
Stroke 時間枠：12 months	Stroke included both ischemic and hemorrhagic stroke.	12 months
Stroke 時間枠：24 months	Stroke included both ischemic and hemorrhagic stroke.	24 months
systemic embolism 時間枠：1 month	An SEE(systemic embolism) was defined by both clinical and objective evidence of sudden loss of end-organ perfusion	1 month
systemic embolism 時間枠：6 months	An SEE(systemic embolism) was defined by both clinical and objective evidence of sudden loss of end-organ perfusion	6 months
systemic embolism 時間枠：12 months	An SEE(systemic embolism) was defined by both clinical and objective evidence of sudden loss of end-organ perfusion	12 months
systemic embolism 時間枠：24 months	An SEE(systemic embolism) was defined by both clinical and objective evidence of sudden loss of end-organ perfusion	24 months
death 時間枠：1 month	Death included overall death, cardiovascular death and non-cardiovascular death.	1 month
death 時間枠：6 months	Death included overall death, cardiovascular death and non-cardiovascular death.	6 months
death 時間枠：12 months	Death included overall death, cardiovascular death and non-cardiovascular death.	12 months
death 時間枠：24 months	Death included overall death, cardiovascular death and non-cardiovascular death.	24 months

二次結果の測定

結果測定	メジャーの説明	時間枠
other clinical events: acute myocardial infarction 時間枠：1 month	Myocardial infarction (MI) is defined as a clinical (or pathologic) event in the setting of myocardial ischemia in which there is evidence of myocardial injury. The diagnosis is secured when there is a rise and/or fall of troponin (high sensitivity assays are preferred) along with supportive evidence in the form of typical symptoms, suggestive electrocardiographic (ECG) changes, or imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.	1 month
other clinical events: acute myocardial infarction 時間枠：6 months	Myocardial infarction (MI) is defined as a clinical (or pathologic) event in the setting of myocardial ischemia in which there is evidence of myocardial injury. The diagnosis is secured when there is a rise and/or fall of troponin (high sensitivity assays are preferred) along with supportive evidence in the form of typical symptoms, suggestive electrocardiographic (ECG) changes, or imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.	6 months
other clinical events: acute myocardial infarction 時間枠：12 months	Myocardial infarction (MI) is defined as a clinical (or pathologic) event in the setting of myocardial ischemia in which there is evidence of myocardial injury. The diagnosis is secured when there is a rise and/or fall of troponin (high sensitivity assays are preferred) along with supportive evidence in the form of typical symptoms, suggestive electrocardiographic (ECG) changes, or imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.	12 months
other clinical events: acute myocardial infarction 時間枠：24 months	Myocardial infarction (MI) is defined as a clinical (or pathologic) event in the setting of myocardial ischemia in which there is evidence of myocardial injury. The diagnosis is secured when there is a rise and/or fall of troponin (high sensitivity assays are preferred) along with supportive evidence in the form of typical symptoms, suggestive electrocardiographic (ECG) changes, or imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.	24 months
other clinical events: pulmonary embolism 時間枠：1 month	Pulmonary embolism is defined as sudden closure of a pulmonary artery or one of its branches, caused by a blood-borne clot or foreign material that plugs the vessel.	1 month
other clinical events: pulmonary embolism 時間枠：6 months	Pulmonary embolism is defined as sudden closure of a pulmonary artery or one of its branches, caused by a blood-borne clot or foreign material that plugs the vessel.	6 months
other clinical events: pulmonary embolism 時間枠：12 months	Pulmonary embolism is defined as sudden closure of a pulmonary artery or one of its branches, caused by a blood-borne clot or foreign material that plugs the vessel.	12 months
other clinical events: pulmonary embolism 時間枠：24 months	Pulmonary embolism is defined as sudden closure of a pulmonary artery or one of its branches, caused by a blood-borne clot or foreign material that plugs the vessel.	24 months
other clinical events: transient ischemic attack 時間枠：1 month	Transient ischemic attack (TIA, Mini-Stroke) is defined as a neurological event with the signs and symptoms of a stroke, but which go away within a short period of time.	1 month
other clinical events: transient ischemic attack 時間枠：6 months	Transient ischemic attack (TIA, Mini-Stroke) is defined as a neurological event with the signs and symptoms of a stroke, but which go away within a short period of time.	6 months
other clinical events: transient ischemic attack 時間枠：12 months	Transient ischemic attack (TIA, Mini-Stroke) is defined as a neurological event with the signs and symptoms of a stroke, but which go away within a short period of time.	12 months
other clinical events: transient ischemic attack 時間枠：24 months	Transient ischemic attack (TIA, Mini-Stroke) is defined as a neurological event with the signs and symptoms of a stroke, but which go away within a short period of time.	24 months
drug adherence 時間枠：1 month	Drug adherence is defined as the extent to which a patient takes his or her medication as prescribed	1 month
drug adherence 時間枠：6 months	Drug adherence is defined as the extent to which a patient takes his or her medication as prescribed	6 months
drug adherence 時間枠：12 months	Drug adherence is defined as the extent to which a patient takes his or her medication as prescribed	12 months
drug adherence 時間枠：24 months	Drug adherence is defined as the extent to which a patient takes his or her medication as prescribed	24 months
questionnaire of life quality (AFEQT) 時間枠：1 month	AFEQT is a validated questionnaire that was patient derived with expert clinical input, and is easy to use format with 20 questions on a seven point Likert scale. AFEQT evaluates Health Related Quality of Life (HRQoL) across three domains Symptoms - Four questions specifically targeted to assess AF related symptoms Daily Activities - Eight questions that evaluate daily function in AF patients Treatment Concerns - Six questions that assess AF treatment concerns in patients Scoring key provides information on how to score the questionnaire and explains how to interpret results. The scoring key provides the following scores:•Overall AFEQT Score (18 questions) •Treatment Satisfaction Score (2 questions)	1 month
questionnaire of life quality (AFEQT) 時間枠：6 months	AFEQT is a validated questionnaire that was patient derived with expert clinical input, and is easy to use format with 20 questions on a seven point Likert scale. AFEQT evaluates Health Related Quality of Life (HRQoL) across three domains Symptoms - Four questions specifically targeted to assess AF related symptoms Daily Activities - Eight questions that evaluate daily function in AF patients Treatment Concerns - Six questions that assess AF treatment concerns in patients Scoring key provides information on how to score the questionnaire and explains how to interpret results. The scoring key provides the following scores:•Overall AFEQT Score (18 questions) •Treatment Satisfaction Score (2 questions)	6 months
questionnaire of life quality (AFEQT) 時間枠：12 months	AFEQT is a validated questionnaire that was patient derived with expert clinical input, and is easy to use format with 20 questions on a seven point Likert scale. AFEQT evaluates Health Related Quality of Life (HRQoL) across three domains Symptoms - Four questions specifically targeted to assess AF related symptoms Daily Activities - Eight questions that evaluate daily function in AF patients Treatment Concerns - Six questions that assess AF treatment concerns in patients Scoring key provides information on how to score the questionnaire and explains how to interpret results. The scoring key provides the following scores:•Overall AFEQT Score (18 questions) •Treatment Satisfaction Score (2 questions)	12 months
questionnaire of life quality (AFEQT) 時間枠：24 months	AFEQT is a validated questionnaire that was patient derived with expert clinical input, and is easy to use format with 20 questions on a seven point Likert scale. AFEQT evaluates Health Related Quality of Life (HRQoL) across three domains Symptoms - Four questions specifically targeted to assess AF related symptoms Daily Activities - Eight questions that evaluate daily function in AF patients Treatment Concerns - Six questions that assess AF treatment concerns in patients Scoring key provides information on how to score the questionnaire and explains how to interpret results. The scoring key provides the following scores:•Overall AFEQT Score (18 questions) •Treatment Satisfaction Score (2 questions)	24 months
cognitive function (KDSQ) 時間枠：1 month	The KDSQ consists of three subscales (i.e., global memory function, other cognitive function, and instrumental activities of daily living), including 15 items that can detect early changes in cognitive decline to diagnose dementia.	1 month
cognitive function (KDSQ) 時間枠：6 months	The KDSQ consists of three subscales (i.e., global memory function, other cognitive function, and instrumental activities of daily living), including 15 items that can detect early changes in cognitive decline to diagnose dementia.	6 months
cognitive function (KDSQ) 時間枠：12 months	The KDSQ consists of three subscales (i.e., global memory function, other cognitive function, and instrumental activities of daily living), including 15 items that can detect early changes in cognitive decline to diagnose dementia.	12 months
cognitive function (KDSQ) 時間枠：24 months	The KDSQ consists of three subscales (i.e., global memory function, other cognitive function, and instrumental activities of daily living), including 15 items that can detect early changes in cognitive decline to diagnose dementia.	24 months

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

Yonsei University

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 (実際)

2020年1月2日

一次修了 (予想される)

2022年8月1日

研究の完了 (予想される)

2024年3月1日

試験登録日

最初に提出

2019年10月7日

QC基準を満たした最初の提出物

2019年10月11日

最初の投稿 (実際)

2019年10月14日

学習記録の更新

投稿された最後の更新 (実際)

2020年1月18日

QC基準を満たした最後の更新が送信されました

2020年1月15日

最終確認日

2020年1月1日

詳しくは

本研究に関する用語

キーワード

Elxaban

追加の関連 MeSH 用語

その他の研究ID番号

4-2019-0536

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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。