Response of Intracardiac Thrombus to Anticoagulants in Patients With Non-valvular Atrial Fibrillation (LYSIS)

Xi'an Jiaotong University

Status: Not yet enrolling

Conditions: Atrial Fibrillation; Intracardiac Thrombus

Treatments: Other: Observational; No Interventions were given.

Study type: Observational

Funder types: Other

Identifiers

NCT06141538

XJTU1AF2023LSK-404

Details and patient eligibility

About

This study aims to analyze changes in the immune status, metabolic status, and host microbiome community structure in non-valvular atrial fibrillation patients with intracardiac thrombus. Additionally, the study aims to analyze factors that influence the responsiveness and occurrence of adverse events related to anticoagulant therapy.

Full description

The researcher-initiated clinical cohort study is a national multicenter, retrospective-prospective study of non-valvular atrial fibrillation patients with intracardiac thrombus, based on molecular biology and multi-omics analysis. The study aims to analyze the changes in the body's immune status, metabolic status, and host microbiome community structure, as well as to analyze the factors that influence the responsiveness of intracardiac thrombus to anticoagulant therapy. The study also evaluates the occurrence of adverse events related to anticoagulation in these patients.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years old, age ≤80 years old
• Patients with atrial fibrillation detected by routine surface 12-lead electrocardiography or Holter
• Transesophageal echocardiography confirmed the presence of cardiac thrombus, and the patient had not received any anticoagulant therapy

Exclusion criteria

• Echocardiography confirmed valvular heart disease
• Contraindications to anticoagulants
• Patients with the previous history of hemorrhagic stroke
• Low platelet count or functional platelet defects
• Congenital or acquired coagulation or bleeding disorders
• Abnormal liver function (liver enzymes >2 times the upper limit)
• Renal failure (endogenous creatinine clearance <30ml/min)
• Surgery was planned within the intended study time or had been operated within 30 days before the study
• Other comorbidities that can cause bleeding, such as tumors
• Patients with autoimmune diseases or immunodeficiency, or patients who are currently using immunosuppressants and immunomodulators
• Patients are currently participating in other clinical studies

Trial design

500 participants in 2 patient groups

Experimental group

Description:

Adequate and regular anticoagulant therapy. Anticoagulation therapy is determined based on the patient's CHADS₂ or CHA₂DS₂-VASc score. Anticoagulant medications include vitamin K antagonists, novel oral anticoagulants (NOACs), and aspirin.

Treatment:

Other: Observational; No Interventions were given.

Control group

Description:

Patients who have not received regular or continuous anticoagulation therapy due to poor compliance or other reasons.

Treatment:

Other: Observational; No Interventions were given.