NCT06431789

Brief Summary

  1. 1.To provide reference for clinical rational use of edoxaban;
  2. 2.Optimize the individualized dosing regimen of edoxaban.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

May 1, 2024

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 29, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

May 29, 2024

Status Verified

May 1, 2024

Enrollment Period

1.5 years

First QC Date

May 22, 2024

Last Update Submit

May 22, 2024

Conditions

Gene PolymorphismEdoxabanRenal Insufficiency

Keywords

Anti-factor Xa activityEdoxabanModerate to severe renal insufficiencySolute carrier organic anion transporter family member 1B1

Outcome Measures

Primary Outcomes (1)

  • Anti-factor Xa activity

    Anti-factor Xa activity

    six months

Other Outcomes (1)

  • Safety index:Thrombotic and bleeding events.

    six months

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated with edoxaban at the First Affiliated Hospital of Shandong First Medical University (Shandong Qianfo Hospital).

You may qualify if:

  • Creatinine clearance of 15-50ml/min was calculated according to the Cockcroft-Gault formula
  • Patients who received edoxaban 30mg once daily for more than 5 days for non-valvular atrial fibrillation (CHADS2VAS2 score ≥2) and deep vein thrombosis prevention or treatment
  • Patients voluntarily participate and sign informed consent

You may not qualify if:

  • Age \< 18 years old
  • Moderate/severe mitral stenosis combined with valvular heart disease, mechanical valve replacement, or rheumatic heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Shandong First Medical University ( Qianfoshan Hospital of Shandong Province )

Jinan, Shandong, 250014, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Yi Han, doctorate

    Qianfoshan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Han, doctorate

CONTACT

1555256512015552565120@163.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate professor of pharmacy

Study Record Dates

First Submitted

May 22, 2024

First Posted

May 29, 2024

Study Start

May 1, 2024

Primary Completion

October 31, 2025

Study Completion

April 30, 2026

Last Updated

May 29, 2024

Record last verified: 2024-05

Locations

CN(1)