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

Atrial Fibrillation Clinical Trial

— LYSIS  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06141538
• Other study ID #: XJTU1AF2023LSK-404
• Status: Not yet recruiting
• Start date: December 31, 2024
• Est. completion date: December 31, 2030

Study information

• Verified date: April 2024
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Guoliang Li
• Phone: +8613759982523
• Email: liguoliang_med[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 31, 2030
• Est. primary completion date: July 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Intracardiac Thrombus
• Thrombosis

Intervention

Other:
• Observational; No Interventions were given.
Observational; No Interventions were given.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xian Jiantong University	Xi'an	Shaanxi

Sponsors (5)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of thrombolysis	Success rate of thrombolysis within 3 months after initiating anticoagulation therapy.	1,2,3 months after enrollment.
Primary	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	Change of incidence of adverse anticoagulation events	Bleeding and thrombotic events	1,2,3 months after enrollment.
Secondary	Change of incidence of all-cause mortality	All-cause mortality diagnosed by clinical doctors.	1,2,3 months after enrollment.
Secondary	Change of incidence of myocardial infarction	Myocardial infarction diagnosed by clinical doctors.	1,2,3 months after enrollment.
Secondary	Change of incidence of coronary revascularization	Coronary revascularization assessed by clinical doctors.	1,2,3 months after enrollment.
Secondary	Change of incidence of stroke	Stroke diagnosed by clinical doctors.	1,2,3 months after enrollment.