Clinical trial NCT06141538: Response of Intracardiac Thrombus to Anticoagulants in Patients With Non-valvular Atrial Fibrillation (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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Atrial Fibrillation
Intracardiac Thrombus
Keywords: Atrial Fibrillation
Intracardiac Thrombus
Anticoagulation Therapy
Major adverse cardiovascular and cerebrovascular events
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: 521 Hospital of NORINCO Group
name: Shaanxi Provincial People's Hospital
name: Xiangyang Central Hospital
name: Henan Provincial People's Hospital
First posted: 2023-11-21
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with non-valvular atrial fibrillation who have been diagnosed with intracardiac thrombosis by First Affiliated Hospital of Xi'an Jiaotong University and multiple medical centers, meet the indications for anticoagulation therapy, and are willing to receive anticoagulation therapy.

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.

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

Primary outcomes:
measure: Success rate of thrombolysis
timeFrame: 1，2，3 months after enrollment.
measure: Change of incidence of MACCE
timeFrame: 1，2，3 months after enrollment.
Secondary outcomes:
measure: Change of incidence of adverse anticoagulation events
timeFrame: 1，2，3 months after enrollment.
measure: Change of incidence of all-cause mortality
timeFrame: 1，2，3 months after enrollment.
measure: Change of incidence of myocardial infarction
timeFrame: 1，2，3 months after enrollment.
measure: Change of incidence of coronary revascularization
timeFrame: 1，2，3 months after enrollment.
measure: Change of incidence of stroke
timeFrame: 1，2，3 months after enrollment.
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xian Jiantong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Guoliang Li
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Chaofeng Sun
role: PRINCIPAL_INVESTIGATOR
References: