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

NCT06141538 | Not Yet Recruiting

• 1 other identifier: XJTU1AF2023LSK-404
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Intracardiac Thrombus

Keywords

Atrial Fibrillation; Intracardiac Thrombus; Anticoagulation Therapy; Major adverse cardiovascular and cerebrovascular events

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Change of incidence of adverse anticoagulation events

  1，2，3 months after enrollment.

• Change of incidence of all-cause mortality

  1，2，3 months after enrollment.

• Change of incidence of myocardial infarction

  1，2，3 months after enrollment.

• Change of incidence of coronary revascularization

  1，2，3 months after enrollment.

• Change of incidence of stroke

  1，2，3 months after enrollment.

Study Arms (2)

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.

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.

Interventions

Observational; No Interventions were given. OTHER

Observational; No Interventions were given.

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

First Affiliated Hospital of Xian Jiantong University

Xi'an, Shaanxi, 710061, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guoliang Li

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

• Chaofeng Sun

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guoliang Li

CONTACT

+8613759982523; liguoliang_med@163.com

Chaofeng Sun

CONTACT

cfsun1@mail.xjtu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 21, 2023
• Study Start: December 31, 2024
• Primary Completion (Estimated): July 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 4, 2024

Record last verified: 2024-04

Locations

CN (1)