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

Not yet recruiting

• Conditions: Intracardiac Thrombus; Atrial Fibrillation
• Interventions: Other: Observational; No Interventions were given.

• Registration Number: NCT06141538
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-11-15
• Study First Submitted QC: 2023-11-15
• Study First Posted: 2023-11-21
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-04
• Study Start: 2024-12-31
• Primary Completion: 2030-07-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	Observational; No Interventions were given.	Patients who have not received regular or continuous anticoagulation therapy due to poor compliance or other reasons.
Experimental group	Observational; No Interventions were given.	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.

Primary Outcome Measures

Name	Time	Method
Change of incidence of MACCE	1，2，3 months after enrollment.	Major adverse cardiovascular and cerebrovascular events, a composite of all-cause mortality, myocardial infarction, coronary revascularization, and stroke.
Success rate of thrombolysis	1，2，3 months after enrollment.	Success rate of thrombolysis within 3 months after initiating anticoagulation therapy.

Secondary Outcome Measures

Name	Time	Method
Change of incidence of all-cause mortality	1，2，3 months after enrollment.	All-cause mortality diagnosed by clinical doctors.
Change of incidence of myocardial infarction	1，2，3 months after enrollment.	Myocardial infarction diagnosed by clinical doctors.
Change of incidence of stroke	1，2，3 months after enrollment.	Stroke diagnosed by clinical doctors.
Change of incidence of adverse anticoagulation events	1，2，3 months after enrollment.	Bleeding and thrombotic events
Change of incidence of coronary revascularization	1，2，3 months after enrollment.	Coronary revascularization assessed by clinical doctors.

Trial Locations

Locations (1)

First Affiliated Hospital of Xian Jiantong University; 🇨🇳 Xi'an, Shaanxi, China