Atrial FibrillationLYSISNCT06141538
Response of Intracardiac Thrombus to Anticoagulants in Patients With Non-valvular Atrial Fibrillation (LYSIS)
An observational study of Atrial Fibrillation and Intracardiac Thrombus, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Intracardiac Thrombus
- Type of treatment
- Pill or oral medicine
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2024to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chaofeng Sun contact
China1 site
First Affiliated Hospital of Xian Jiantong University
Xi'an, Shaanxi, 710061
About this study
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
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.
Read the 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.
- Conditions
- Atrial Fibrillation, Intracardiac Thrombus
- Being tested
- Observational; No Interventions were given.
- Keywords
- Atrial Fibrillation, Intracardiac Thrombus, Anticoagulation Therapy, Major adverse cardiovascular and cerebrovascular events
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational; No Interventions were given.Other
Observational; No Interventions were given.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Observational; No Interventions were given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of thrombolysis
Success rate of thrombolysis within 3 months after initiating anticoagulation therapy.
Measured: 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.
Measured: 1，2，3 months after enrollment.
Secondary outcomes (5)
Change of incidence of adverse anticoagulation events
Bleeding and thrombotic events
Measured: 1，2，3 months after enrollment.
Change of incidence of all-cause mortality
All-cause mortality diagnosed by clinical doctors.
Measured: 1，2，3 months after enrollment.
Change of incidence of myocardial infarction
Myocardial infarction diagnosed by clinical doctors.
Measured: 1，2，3 months after enrollment.
Change of incidence of coronary revascularization
Coronary revascularization assessed by clinical doctors.
Measured: 1，2，3 months after enrollment.
Change of incidence of stroke
Stroke diagnosed by clinical doctors.
Measured: 1，2，3 months after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start31 Dec 2024 (estimated)
- Primary completion31 Jul 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- 521 Hospital of NORINCO Group, Shaanxi Provincial People's Hospital, Xiangyang Central Hospital, Henan Provincial People's Hospital
- Responsible party
- Sponsor
- Investigators
- Guoliang Li, Principal investigator, First Affiliated Hospital Xi'an Jiaotong UniversityChaofeng Sun, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141538
- Sponsor's protocol ID
- XJTU1AF2023LSK-404
- Acronym
- LYSIS
- Status last verified
- Apr 2024
- First submitted
- 15 Nov 2023
- Last updated
- 4 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06141538
- Acronym / sponsor ID
- LYSIS / XJTU1AF2023LSK-404
- Conditions
- Atrial Fibrillation, Intracardiac Thrombus
- Keywords
- Atrial Fibrillation, Intracardiac Thrombus, Anticoagulation Therapy, Major adverse cardiovascular and cerebrovascular events
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- 521 Hospital of NORINCO Group, Shaanxi Provincial People's Hospital, Xiangyang Central Hospital, Henan Provincial People's Hospital
- Study start
- 31 Dec 2024 (estimated)
- Primary completion
- 31 Jul 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Other: Observational; No Interventions were given.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. |
| Control group | – | Other: Observational; No Interventions were given.Patients who have not received regular or continuous anticoagulation therapy due to poor compliance or other reasons. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational; No Interventions were given.Observational; No Interventions were given. | Other | Control group, Experimental group |
Primary outcome
Success rate of thrombolysis
Time frame: 1，2，3 months after enrollment.
Success rate of thrombolysis within 3 months after initiating anticoagulation therapy.
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.
5 secondary outcomes
Change of incidence of adverse anticoagulation events
Time frame: 1，2，3 months after enrollment.
Change of incidence of all-cause mortality
Time frame: 1，2，3 months after enrollment.
Change of incidence of myocardial infarction
Time frame: 1，2，3 months after enrollment.
Change of incidence of coronary revascularization
Time frame: 1，2，3 months after enrollment.
Change of incidence of stroke
Time frame: 1，2，3 months after enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chaofeng Sun contact
Guoliang Li principal investigator
First Affiliated Hospital Xi'an Jiaotong University
Chaofeng Sun principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Intracardiac Thrombus, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guoliang Li (+8613759982523, liguoliang_med@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of thrombolysis (time frame: 1，2，3 months after enrollment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.