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NCT Number: NCT06141538

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

First Affiliated Hospital of Xian Jiantong University

Xi'an, Shaanxi, 710061, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational; No Interventions were given.

Other

Observational; No Interventions were given.

Primary outcomes

  1. Success rate of thrombolysis

    Time frame: 1,2,3 months after enrollment.

    Success rate of thrombolysis within 3 months after initiating anticoagulation therapy.

  2. 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.

Secondary outcomes

  1. Change of incidence of adverse anticoagulation events

    Time frame: 1,2,3 months after enrollment.

    Bleeding and thrombotic events

  2. Change of incidence of all-cause mortality

    Time frame: 1,2,3 months after enrollment.

    All-cause mortality diagnosed by clinical doctors.

  3. Change of incidence of myocardial infarction

    Time frame: 1,2,3 months after enrollment.

    Myocardial infarction diagnosed by clinical doctors.

  4. Change of incidence of coronary revascularization

    Time frame: 1,2,3 months after enrollment.

    Coronary revascularization assessed by clinical doctors.

  5. Change of incidence of stroke

    Time frame: 1,2,3 months after enrollment.

    Stroke diagnosed by clinical doctors.

Study contacts

Contact information is provided by the study sponsor or research team.

Chaofeng Sun

CONTACT

[email protected]

Guoliang Li

CONTACT

[email protected]

+8613759982523

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Collaborators

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

Registry information

Official study 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

Acronym: LYSIS

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Nov 21, 2023
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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