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

Sponsor

First Affiliated Hospital Xi'an Jiaotong University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06141538

Collaborator

521 Hospital of NORINCO Group (Other), Shaanxi Provincial People's Hospital (Other), Xiangyang Central Hospital (Other), Henan Provincial People's Hospital (Other)

500

Enrollment

Location

Anticipated Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Intracardiac Thrombus	Other: Observational; No Interventions were given.

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 Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Other

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

Anticipated Study Start Date :

Nov 30, 2023

Anticipated Primary Completion Date :

Jul 31, 2030

Anticipated Study Completion Date :

Dec 31, 2030

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental group

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.

Observational; No Interventions were given.

Control group

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

Other: Observational; No Interventions were given.

Observational; No Interventions were given.

Outcome Measures

Primary Outcome Measures

Success rate of thrombolysis [1，2，3 months after enrollment.]
Success rate of thrombolysis within 3 months after initiating anticoagulation therapy.
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.

Secondary Outcome Measures

Change of incidence of adverse anticoagulation events [1，2，3 months after enrollment.]
Bleeding and thrombotic events
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 coronary revascularization [1，2，3 months after enrollment.]
Coronary revascularization assessed by clinical doctors.
Change of incidence of stroke [1，2，3 months after enrollment.]
Stroke diagnosed by clinical doctors.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Affiliated Hospital of Xian Jiantong University	Xi'an	Shaanxi	China	710061

Sponsors and Collaborators

First Affiliated Hospital Xi'an Jiaotong University
521 Hospital of NORINCO Group
Shaanxi Provincial People's Hospital
Xiangyang Central Hospital
Henan Provincial People's Hospital

Investigators

Principal Investigator: Guoliang Li, First Affiliated Hospital Xi'an Jiaotong University
Principal Investigator: Chaofeng Sun, First Affiliated Hospital Xi'an Jiaotong University