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

Study Overview
=================
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.

Official Title
-----------------
Response of Intracardiac Thrombus to Anticoagulants in Patients With Non-valvular Atrial Fibrillation (LYSIS): an Investigator-initiated, National, Multicenter, Retrospective-prospective, Observational Cohort Study

Conditions
-----------------
Atrial Fibrillation, Intracardiac Thrombus

Intervention / Treatment
-----------------
* Other: Observational; No Interventions were given.


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental group<br>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. | Other: Observational; No Interventions were given.<br>* Observational; No Interventions were given.<br>|
| Control group<br>Patients who have not received regular or continuous anticoagulation therapy due to poor compliance or other reasons. | Other: Observational; No Interventions were given.<br>* Observational; No Interventions were given.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial Fibrillation, Intracardiac Thrombus, Anticoagulation Therapy, Major adverse cardiovascular and cerebrovascular events