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

Yue LI

Status: Unknown

Conditions: Atrial Fibrillation; Anticoagulant Therapy; Bleeding

Treatments: Diagnostic Test: Metabolomics; Diagnostic Test: Proteomics

Study type: Observational

Funder types: Other

Identifiers

NCT05181774

AF and stroke 2

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

100 participants in 2 patient groups

Bleeding

Description:

After one-year follow-up, AF patients with anticoagulation-related bleeding complications were enrolled in this group.

Treatment:

Diagnostic Test: Metabolomics

Diagnostic Test: Proteomics

Non-bleeding

Description:

After one-year follow-up, AF patients without anticoagulation-related bleeding complications were enrolled in this group.

Treatment:

Diagnostic Test: Metabolomics

Diagnostic Test: Proteomics