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

2020. január 15. frissítette: 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.

A tanulmány áttekintése

Állapot

Toborzás

Körülmények

Tanulmány típusa

Megfigyelő

Beiratkozás (Várható)

5000

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

  • Név: Boyoung Jung
  • Telefonszám: +82 02-2228-8447
  • E-mail: cby6908@yuhs.ac

Tanulmányi helyek

  • Koreai Köztársaság
      • Seoul, Koreai Köztársaság, 03722
        • Toborzás
        • Division of Cardiology Severance Cardiovascular Hospital, Yonsei University College of Medicine
        • Kapcsolatba lépni:
          • Boyoung Joung, M.D., Ph.D.
          • Telefonszám: +82-2228-8447
          • E-mail: CBY690@yuhs.ac

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

20 év és régebbi (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Mintavételi módszer

Nem valószínűségi minta

Tanulmányi populáció

Atrial fibrillatin patients taking Elxaban in general hospital

Leírás

Inclusion Criteria:

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

Exclusion Criteria:

  1. patients who do not agree with study inclusion
  2. patients with age less than 19
  3. Pregnancy, Breastfeeding

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

Kohorszok és beavatkozások

Csoport / Kohorsz
Elxaban group
AF patients taking Elxaban

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
major bleeding
Időkeret: 1 month

Major bleeding is defined according to the criteria of the International Society on Thrombosis and Haemostasis (ISTH).

  1. Fatal bleeding, and/or
  2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or
  3. 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
Időkeret: 6 months

Major bleeding is defined according to the criteria of the International Society on Thrombosis and Haemostasis (ISTH).

  1. Fatal bleeding, and/or
  2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or
  3. 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
Időkeret: 12 months

Major bleeding is defined according to the criteria of the International Society on Thrombosis and Haemostasis (ISTH).

  1. Fatal bleeding, and/or
  2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or
  3. 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
Időkeret: 24 months

Major bleeding is defined according to the criteria of the International Society on Thrombosis and Haemostasis (ISTH).

  1. Fatal bleeding, and/or
  2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or
  3. 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
Időkeret: 1 month
Stroke included both ischemic and hemorrhagic stroke.
1 month
Stroke
Időkeret: 6 months
Stroke included both ischemic and hemorrhagic stroke.
6 months
Stroke
Időkeret: 12 months
Stroke included both ischemic and hemorrhagic stroke.
12 months
Stroke
Időkeret: 24 months
Stroke included both ischemic and hemorrhagic stroke.
24 months
systemic embolism
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 24 months
An SEE(systemic embolism) was defined by both clinical and objective evidence of sudden loss of end-organ perfusion
24 months
death
Időkeret: 1 month
Death included overall death, cardiovascular death and non-cardiovascular death.
1 month
death
Időkeret: 6 months
Death included overall death, cardiovascular death and non-cardiovascular death.
6 months
death
Időkeret: 12 months
Death included overall death, cardiovascular death and non-cardiovascular death.
12 months
death
Időkeret: 24 months
Death included overall death, cardiovascular death and non-cardiovascular death.
24 months

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
other clinical events: acute myocardial infarction
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 1 month
Drug adherence is defined as the extent to which a patient takes his or her medication as prescribed
1 month
drug adherence
Időkeret: 6 months
Drug adherence is defined as the extent to which a patient takes his or her medication as prescribed
6 months
drug adherence
Időkeret: 12 months
Drug adherence is defined as the extent to which a patient takes his or her medication as prescribed
12 months
drug adherence
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Yonsei University

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2020. január 2.

Elsődleges befejezés (Várható)

2022. augusztus 1.

A tanulmány befejezése (Várható)

2024. március 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2019. október 7.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2019. október 11.

Első közzététel (Tényleges)

2019. október 14.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2020. január 18.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2020. január 15.

Utolsó ellenőrzés

2020. január 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • 4-2019-0536

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

NEM

Gyógyszer- és eszközinformációk, tanulmányi dokumentumok

Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

Nem

Egy amerikai FDA által szabályozott eszközterméket tanulmányoz

Nem

Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .

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