ThrombosisNCT07523880
Multi-Omics-Based Novel Thrombosis and Bleeding Markers and Risk Model for CHD
An observational study of Thrombosis and Bleeding, run by Xueyan Zhao at 3 sites in China.
Trial summary
Patients with coronary heart disease who take dual antiplatelet therapy face two serious risks: thrombosis and major bleeding. This study aims to develop better ways to predict these risks and guide personalized treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombosis, Bleeding, Coronary Artery Disease (CAD)
- How many people
- 12,154 participants
- Where
- 3 sitesChina
- Study dates
- 1 Aug 2025to Jul 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of patients with coronary heart disease who are receiving dual antiplatelet therapy after percutaneous coronary intervention. The study includes a retrospective cohort of approximately 10,154 patients with existing baseline and follow-up data and biospecimens, derived from a previously established patient cohort. In addition, a prospective cohort of at least 2,000 newly enrolled patients will be recruited.
Who may be able to join
- Age ≥ 18 years.
- Hospitalized due to symptoms or objective evidence of coronary heart disease and planned for long-term antithrombotic therapy.
- Diagnosis of acute coronary syndrome or stable coronary heart disease undergoing percutaneous coronary intervention (PCI), with clinical stability meeting discharge criteria after treatment.
- For patients from the existing cohort: minimum 2 years of follow-up with complete clinical data and blood specimens available; approval for use of these data and specimens has been obtained, with a waiver of re-consent.
- For newly enrolled patients: voluntary written informed consent provided by the patient or legal representative, agreement to provide blood samples, and acceptance of follow-up procedures.
Who cannot join
- For patients from the existing cohort:
- Severe missing or erroneous baseline or clinical data that cannot be corrected by source verification.
- No available blood specimen, or specimen that does not meet testing requirements.
- For newly enrolled patients:
- Presence of serious comorbid conditions with life expectancy ≤ 6 months.
- Conditions that significantly affect study compliance or the ability to complete follow-up.
- Contraindications to blood sampling.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, 100037
Xueyan Zhao, PhD, +86 13683185878, zhao_xueyan@sina.com
- Recruiting
General Hospital of Northern Theater Command of Chinese People's Liberation Army
Shenyang, Liaoning, 110016
Yang Li, PhD, +86 15309889820, liyang19830925@126.com
- Recruiting
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan
Chao Liu
About this study
Official title: Multi-Omics-Based Development of Novel Thrombosis and Bleeding Markers and Construction of a Risk Prediction Model in Coronary Heart Disease
Patients with coronary heart disease who take dual antiplatelet therapy face two serious risks: thrombosis and major bleeding. This study aims to develop better ways to predict these risks and guide personalized treatment.
The investigators will use a large, long-term follow-up study of Chinese patients with coronary heart disease. This research plans to discover new biomarkers related to clot and bleeding risk. The study will combine information from proteins, metabolites, sugars attached to proteins, genes, and medical images. Using machine learning methods, the investigators will identify the most important markers and test them in the patient group of this study.
Read more
The investigators will then build new risk prediction models that include these new markers together with traditional risk scores (such as GRACE, PARIS, and Precise-DAPT). This study will check whether these new models are better than existing ones at predicting who will develop clots or bleeding and at helping doctors decide on the best treatment for each patient.
The new aspects of this research are: (1) using advanced multi-omics technology to find novel markers specifically for Chinese patients; (2) combining clinical, biological, and imaging data to improve prediction accuracy; and (3) using machine learning to create more precise risk models.
The goal is to provide doctors with a more accurate tool to assess each patient's risk of clots and bleeding. This will help them choose the safest and most effective antiplatelet treatment, reduce serious complications, and improve patient care.
- Conditions
- Thrombosis, Bleeding, Coronary Artery Disease (CAD)
- Keywords
- Coronary Heart Disease, Dual Antiplatelet Therapy, Thrombosis, Bleeding, Multi-Omics, Biomarkers, Risk Prediction Model, Machine Learning
- Medical subject headings
- Thrombosis, Hemorrhage, Coronary Artery Disease, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective Cohort | Approximately 10,154 patients with coronary heart disease selected from an established cohort of 18,701 patients based on inclusion/exclusion criteria. | |
| Prospective Cohort | At least 2,000 newly enrolled patients with coronary heart disease. Participants will be followed prospectively for thrombotic and bleeding events. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Composite of all-cause death, non-fatal myocardial infarction, ischemic stroke, and unplanned revascularization.
Measured: Up to 24 months after enrollment
Major Bleeding Events
Bleeding Academic Research Consortium (BARC) type 3 or type 5 bleeding.
Measured: Up to 24 months after enrollment
Secondary outcomes (4)
All-Cause Death
Measured: Up to 24 months after enrollment
Myocardial Infarction
Measured: Up to 24 months after enrollment
Stroke
Measured: Up to 24 months after enrollment
Stent Thrombosis
Measured: Up to 24 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 posted13 Apr 2026
- Study start1 Aug 2025
- Primary completionJan 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 12,154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xueyan Zhao
- Sponsor type
- University, hospital or other
- Collaborators
- The General Hospital of Northern Theater Command, Central China Fuwai Hospital of Zhengzhou University
- Responsible party
- Sponsor-investigator, Xueyan Zhao, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523880
- Sponsor's protocol ID
- 2025ZD0546401
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Omics-Based Development of Novel Thrombosis and Bleeding Markers and Construction of a Risk Prediction Model in Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT07523880
- Acronym / sponsor ID
- 2025ZD0546401
- Conditions
- Thrombosis, Bleeding, Coronary Artery Disease (CAD)
- Keywords
- Coronary Heart Disease, Dual Antiplatelet Therapy, Thrombosis, Bleeding, Multi-Omics, Biomarkers, Risk Prediction Model, Machine Learning
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 12,154 participants (estimated)
- Lead sponsor
- Xueyan ZhaoUniversity, hospital or other
- Collaborators
- The General Hospital of Northern Theater Command, Central China Fuwai Hospital of Zhengzhou University
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 13 Apr 2026 (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.
Patients with coronary heart disease who take dual antiplatelet therapy face two serious risks: thrombosis and major bleeding. This study aims to develop better ways to predict these risks and guide personalized treatment.
The investigators will use a large, long-term follow-up study of Chinese patients with coronary heart disease. This research plans to discover new biomarkers related to clot and bleeding risk. The study will combine information from proteins, metabolites, sugars attached to proteins, genes, and medical images. Using machine learning methods, the investigators will identify the most important markers and test them in the patient group of this study.
The investigators will then build new risk prediction models that include these new markers together with traditional risk scores (such as GRACE, PARIS, and Precise-DAPT). This study will check whether these new models are better than existing ones at predicting who will develop clots or bleeding and at helping doctors decide on the best treatment for each patient.
The new aspects of this research are: (1) using advanced multi-omics technology to find novel markers specifically for Chinese patients; (2) combining clinical, biological, and imaging data to improve prediction accuracy; and (3) using machine learning to create more precise risk models.
The goal is to provide doctors with a more accurate tool to assess each patient's risk of clots and bleeding. This will help them choose the safest and most effective antiplatelet treatment, reduce serious complications, and improve patient care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective Cohort | – | –Approximately 10,154 patients with coronary heart disease selected from an established cohort of 18,701 patients based on inclusion/exclusion criteria. |
| Prospective Cohort | – | –At least 2,000 newly enrolled patients with coronary heart disease. Participants will be followed prospectively for thrombotic and bleeding events. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients with coronary heart disease who are receiving dual antiplatelet therapy after percutaneous coronary intervention. The study includes a retrospective cohort of approximately 10,154 patients with existing baseline and follow-up data and biospecimens, derived from a previously established patient cohort. In addition, a prospective cohort of at least 2,000 newly enrolled patients will be recruited.
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- Hospitalized due to symptoms or objective evidence of coronary heart disease and planned for long-term antithrombotic therapy.
- Diagnosis of acute coronary syndrome or stable coronary heart disease undergoing percutaneous coronary intervention (PCI), with clinical stability meeting discharge criteria after treatment.
- For patients from the existing cohort: minimum 2 years of follow-up with complete clinical data and blood specimens available; approval for use of these data and specimens has been obtained, with a waiver of re-consent.
- For newly enrolled patients: voluntary written informed consent provided by the patient or legal representative, agreement to provide blood samples, and acceptance of follow-up procedures.
Key exclusion criteria (7 listed)
- Severe missing or erroneous baseline or clinical data that cannot be corrected by source verification.
- No available blood specimen, or specimen that does not meet testing requirements.
- Presence of serious comorbid conditions with life expectancy ≤ 6 months.
- Conditions that significantly affect study compliance or the ability to complete follow-up.
- Contraindications to blood sampling.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Time frame: Up to 24 months after enrollment
Composite of all-cause death, non-fatal myocardial infarction, ischemic stroke, and unplanned revascularization.
Major Bleeding Events
Time frame: Up to 24 months after enrollment
Bleeding Academic Research Consortium (BARC) type 3 or type 5 bleeding.
4 secondary outcomes
All-Cause Death
Time frame: Up to 24 months after enrollment
Myocardial Infarction
Time frame: Up to 24 months after enrollment
Stroke
Time frame: Up to 24 months after enrollment
Stent Thrombosis
Time frame: Up to 24 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 13 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombosis and Bleeding, run by Xueyan Zhao at 3 sites 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Xueyan Zhao, PhD (+86 13683185878, zhao_xueyan@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) (time frame: Up to 24 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 13 Apr 2026.