NCT04125641

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 14, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

January 2, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

2.6 years

First QC Date

October 7, 2019

Last Update Submit

January 15, 2020

Conditions

Atrial Fibrillation

Keywords

Elxaban

Outcome Measures

Primary Outcomes (16)

  • major bleeding

    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

    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

    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

    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

    Stroke included both ischemic and hemorrhagic stroke.

    1 month

  • Stroke

    Stroke included both ischemic and hemorrhagic stroke.

    6 months

  • Stroke

    Stroke included both ischemic and hemorrhagic stroke.

    12 months

  • Stroke

    Stroke included both ischemic and hemorrhagic stroke.

    24 months

  • systemic embolism

    An SEE(systemic embolism) was defined by both clinical and objective evidence of sudden loss of end-organ perfusion

    1 month

  • systemic embolism

    An SEE(systemic embolism) was defined by both clinical and objective evidence of sudden loss of end-organ perfusion

    6 months

  • systemic embolism

    An SEE(systemic embolism) was defined by both clinical and objective evidence of sudden loss of end-organ perfusion

    12 months

  • systemic embolism

    An SEE(systemic embolism) was defined by both clinical and objective evidence of sudden loss of end-organ perfusion

    24 months

  • death

    Death included overall death, cardiovascular death and non-cardiovascular death.

    1 month

  • death

    Death included overall death, cardiovascular death and non-cardiovascular death.

    6 months

  • death

    Death included overall death, cardiovascular death and non-cardiovascular death.

    12 months

  • death

    Death included overall death, cardiovascular death and non-cardiovascular death.

    24 months

Secondary Outcomes (24)

  • other clinical events: acute myocardial infarction

    1 month

  • other clinical events: acute myocardial infarction

    6 months

  • other clinical events: acute myocardial infarction

    12 months

  • other clinical events: acute myocardial infarction

    24 months

  • other clinical events: pulmonary embolism

    1 month

  • +19 more secondary outcomes

Study Arms (1)

Elxaban group

AF patients taking Elxaban

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Atrial fibrillatin patients taking Elxaban in general hospital

You may qualify if:

  • patients with atrial fibrillation taking Elxaban (patients with age more than 19)

You may not qualify if:

  • patients with age less than 19
  • Pregnancy, Breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology Severance Cardiovascular Hospital, Yonsei University College of Medicine

Seoul, 03722, South Korea

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Boyoung Jung

CONTACT

+82 02-2228-8447cby6908@yuhs.ac

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2019

First Posted

October 14, 2019

Study Start

January 2, 2020

Primary Completion

August 1, 2022

Study Completion

March 1, 2024

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)