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

April 2, 2024 updated by: First Affiliated Hospital Xi'an Jiaotong University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • First Affiliated Hospital of Xian Jiantong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate of thrombolysis
Time Frame: 1，2，3 months after enrollment.
Success rate of thrombolysis within 3 months after initiating anticoagulation therapy.
1，2，3 months after enrollment.
Change of incidence of MACCE
Time Frame: 1，2，3 months after enrollment.
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
Time Frame: 1，2，3 months after enrollment.
Bleeding and thrombotic events
1，2，3 months after enrollment.
Change of incidence of all-cause mortality
Time Frame: 1，2，3 months after enrollment.
All-cause mortality diagnosed by clinical doctors.
1，2，3 months after enrollment.
Change of incidence of myocardial infarction
Time Frame: 1，2，3 months after enrollment.
Myocardial infarction diagnosed by clinical doctors.
1，2，3 months after enrollment.
Change of incidence of coronary revascularization
Time Frame: 1，2，3 months after enrollment.
Coronary revascularization assessed by clinical doctors.
1，2，3 months after enrollment.
Change of incidence of stroke
Time Frame: 1，2，3 months after enrollment.
Stroke diagnosed by clinical doctors.
1，2，3 months after enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Collaborators

Shaanxi Provincial People's Hospital
Henan Provincial People's Hospital
521 Hospital of NORINCO Group
Xiangyang Central Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 31, 2024

Primary Completion (Estimated)

July 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

November 15, 2023

First Submitted That Met QC Criteria

November 15, 2023

First Posted (Actual)

November 21, 2023

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF2023LSK-404

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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