Prediction of Bleeding Risk After Anticoagulant Therapy for Atrial Fibrillation Based on Proteomics and Metabolomics

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05181774

Enrollment

100

Registered

2022-01-06

Start date

2021-12-20

Completion date

2023-12-31

Last updated

2022-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anticoagulant Therapy, Atrial Fibrillation, Bleeding

Keywords

Atrial Fibrillation, Bleeding, Anticoagulant therapy

Brief summary

Objectives: Atrial fibrillation (AF) is the most common arrhythmia. Anticoagulation with warfarin or new oral anticoagulants in patients with AF can significantly reduce thromboembolic events. However, due to the lack of bleeding risk predictors of oral anticoagulants, the bleeding risk of patients with AF cannot be accurately evaluated. The purpose of this study is to screen biomarkers that can predict bleeding in patients with AF through proteomics and metabolomics, and construct the protein metabolic network pathway of anticoagulant bleeding in patients with AF. Design: AF patients treated with oral anticoagulants were enrolled in this study. Blood samples were centrifuged and the supernatant was stored in the refrigerator at - 80 ℃. All patients were followed up for one year to determine whether bleeding occurred after oral anticoagulants. Proteomic data were obtained by LC-MS/MS Analysis-DIA platform. Metabolomic data were obtained by UPLC-QTOF/MS platform. All of the omics data were used to compare proteins/enzymes with metabolic pathways. Quantitative changes of individual metabolites and proteins were calculated and graphed using the KEGG mapping tools.

Interventions

DIAGNOSTIC_TESTProteomics

Proteomic data were obtained by LC-MS/MS Analysis-DIA platform.

DIAGNOSTIC_TESTMetabolomics

Metabolomic data were obtained by UPLC-QTOF/MS platform.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age 18 years or above 2. Admission with atrial fibrillation or clinic visit for atrial fibrillation 3. Receive routine anticoagulant therapy; 4. Signing the consent form

Exclusion criteria

1. Pregnant women; 2. Lactating women; 3. Severe mitral stenosis; 4. Severe impairment of liver function; 5. Severe renal insufficiency; 6. Thyroid dysfunction requiring treatment; 7. Have a history of severe bleeding within five years, such as intracerebral hemorrhage and gastrointestinal bleeding.

Design outcomes

Primary

Measure	Time frame	Description
Biomarkers predicting bleeding in AF patients through proteomics and metabolomics.	1 year	Proteomic data were obtained by LC-MS/MS Analysis-DIA platform. Metabolomic data were obtained by UPLC-QTOF/MS platform.

Secondary

Measure	Time frame	Description
Protein metabolic network pathway of anticoagulant bleeding in patients with AF.	1 year	All of the omics data were used to compare proteins/enzymes with metabolic pathways.

Countries

China

Contacts

Primary ContactHaiyu Zhang, MD

zhanghaiyu819@163.com+8645185555009

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026