NCT05645913

Brief Summary

In this study, the investigators evaluated the association between various measures of adiposity \[BMI and waist circumference (WC)\] and clinical outcomes in Asian patients with AF who were prescribed OAC, using a nationwide population based cohort.

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
56,272

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Typical duration 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

Study Start

First participant enrolled

January 1, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 12, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

2.8 years

First QC Date

December 2, 2022

Last Update Submit

July 26, 2023

Conditions

Atrial FibrillationObesityPrognosisAnticoagulants

Outcome Measures

Primary Outcomes (1)

  • Composite of Outcomes

    Thromboembolism+Bleeding+Death

    5 years

Secondary Outcomes (3)

  • Thromboembolism

    5 years

  • Bleeding

    5 years

  • Death

    5 years

Study Arms (1)

Atrial fibrillation with oral anticoagulant

patients who were newly receiving an oral anticoagulant for atrial fibrillation during study period

Drug: Oral anticoagulant

Interventions

Oral anticoagulantDRUG

Oral anticoagulant that was continued at least 25days, inculding warfarin and new oral anticoagulant (NOAC)

Also known as: Oral anticoagulant medication
Atrial fibrillation with oral anticoagulant

Eligibility Criteria

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

This retrospective nationwide cohort study used administrative claims data from the Korean National Health Insurance Service (NHIS) and the combined health check-up database of the National Health Insurance Corporation between 2013 and 2020. We included oral anticoagulant (OAC) new users diagnosed with atrial fibrillation (AF) between January 2015 and December 2020. Patients aged \<20 years, those who were regarded as valvular AF patients (patients with mitral stenosis or prosthetic heart valve), those with possible alternative indications for OAC (pulmonary embolism, deep vein thrombosis, or recent joint replacement surgery), and those with cancer were excluded from the analysis.

You may qualify if:

  • Oral anticoagulant (OAC) new users diagnosed with atrial fibrillation (AF) between January 2015 and December 2020

You may not qualify if:

  • Patients aged \<20 years
  • Valvular AF patients
  • Possible alternative indications for OAC (pulmonary embolism, deep vein thrombosis, or recent joint replacement surgery)
  • Cancer patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou University School of Medicine

Suwon, Gyeonggi-do, 16499, South Korea

Location

Related Publications (3)

  • Kim MS, Kim WJ, Khera AV, Kim JY, Yon DK, Lee SW, Shin JI, Won HH. Association between adiposity and cardiovascular outcomes: an umbrella review and meta-analysis of observational and Mendelian randomization studies. Eur Heart J. 2021 Sep 7;42(34):3388-3403. doi: 10.1093/eurheartj/ehab454.

    PMID: 34333589RESULT

  • Lee SR, Choi EK, Jung JH, Park SH, Han KD, Oh S, Lip GYH. Body Mass Index and Clinical Outcomes in Asian Patients With Atrial Fibrillation Receiving Oral Anticoagulation. Stroke. 2021 Jan;52(2):521-530. doi: 10.1161/STROKEAHA.120.030356. Epub 2021 Jan 11.

    PMID: 33423512RESULT

  • Park SJ, Ha KH, Kim DJ. Body mass index and cardiovascular outcomes in patients with acute coronary syndrome by diabetes status: the obesity paradox in a Korean national cohort study. Cardiovasc Diabetol. 2020 Nov 10;19(1):191. doi: 10.1186/s12933-020-01170-w.

    PMID: 33172464RESULT

MeSH Terms

Conditions

Atrial FibrillationObesity

Interventions

Anticoagulants

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and Symptoms

Intervention Hierarchy (Ancestors)

Hematologic AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Kwang-No LEE

    Ajou University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 2, 2022

First Posted

December 12, 2022

Study Start

January 1, 2022

Primary Completion

October 31, 2024

Study Completion

December 31, 2024

Last Updated

July 27, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)