Multi-Omics-Based Novel Thrombosis and Bleeding Markers and Risk Model for CHD

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.

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 Overview

• Status: Recruiting
• Conditions: Thrombosis; Bleeding; Coronary Artery Disease (CAD)

• Study Type: Observational
• Enrollment (Estimated): 12154

Contacts and Locations

• Study Contact: Name: Xueyan Zhao, PhD; Phone Number: +86 13683185878; Email: zhao_xueyan@sina.com

Study Locations

• China
  • Beijing, China, 100037
    • Recruiting
    • Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
    • Contact: Xueyan Zhao, PhD; Phone Number: +86 13683185878; Email: zhao_xueyan@sina.com
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • Fuwai Central China Cardiovascular Hospital
      • Contact: Chao Liu
  • Liaoning
    • Shenyang, Liaoning, China, 110016
      • Recruiting
      • General Hospital of Northern Theater Command of Chinese People's Liberation Army
      • Contact: Yang Li, PhD; Phone Number: +86 15309889820; Email: liyang19830925@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

1. Age ≥ 18 years.
2. Hospitalized due to symptoms or objective evidence of coronary heart disease and planned for long-term antithrombotic therapy.
3. Diagnosis of acute coronary syndrome or stable coronary heart disease undergoing percutaneous coronary intervention (PCI), with clinical stability meeting discharge criteria after treatment.
4. 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.

Exclusion Criteria:

For patients from the existing cohort:

1. Severe missing or erroneous baseline or clinical data that cannot be corrected by source verification.
2. No available blood specimen, or specimen that does not meet testing requirements.

For newly enrolled patients:

1. Presence of serious comorbid conditions with life expectancy ≤ 6 months.
2. Conditions that significantly affect study compliance or the ability to complete follow-up.
3. Contraindications to blood sampling.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)	Composite of all-cause death, non-fatal myocardial infarction, ischemic stroke, and unplanned revascularization.	Up to 24 months after enrollment
Major Bleeding Events	Bleeding Academic Research Consortium (BARC) type 3 or type 5 bleeding.	Up to 24 months after enrollment

Secondary Outcome Measures

Outcome Measure	Time Frame
All-Cause Death	Up to 24 months after enrollment
Myocardial Infarction	Up to 24 months after enrollment
Stroke	Up to 24 months after enrollment
Stent Thrombosis	Up to 24 months after enrollment

Collaborators and Investigators

• Sponsor: Xueyan Zhao
• Collaborators: The General Hospital of Northern Theater Command; Central China Fuwai Hospital of Zhengzhou University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: April 6, 2026
• First Submitted That Met QC Criteria: April 6, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Thrombosis; Biomarkers; Bleeding; Coronary Heart Disease; Machine Learning; Dual Antiplatelet Therapy; Risk Prediction Model; Multi-Omics
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Embolism and Thrombosis; Arteriosclerosis; Arterial Occlusive Diseases; Myocardial Ischemia; Pathological Conditions, Signs and Symptoms; Thrombosis; Coronary Artery Disease; Coronary Disease; Hemorrhage
• Other Study ID Numbers: 2025ZD0546401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No