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NCT Number: NCT07523880

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

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.

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Key information

Conditions

Thrombosis Arterial Occlusive Diseases Arteriosclerosis Bleeding Cardiovascular Diseases Coronary Artery Disease Coronary Artery Disease (CAD) Coronary Disease Embolism and Thrombosis Heart Diseases Hemorrhage Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuwai Central China Cardiovascular Hospital, Zhengzhou, Henan, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. Major Bleeding Events

    Time frame: Up to 24 months after enrollment

    Bleeding Academic Research Consortium (BARC) type 3 or type 5 bleeding.

Secondary outcomes

  1. All-Cause Death

    Time frame: Up to 24 months after enrollment

  2. Myocardial Infarction

    Time frame: Up to 24 months after enrollment

  3. Stroke

    Time frame: Up to 24 months after enrollment

  4. Stent Thrombosis

    Time frame: Up to 24 months after enrollment

Study contacts

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

Xueyan Zhao, PhD

CONTACT

[email protected]

+86 13683185878

Sponsors and collaborators

Lead sponsor

Xueyan Zhao

Other

Collaborators

  • Central China Fuwai Hospital of Zhengzhou University
  • The General Hospital of Northern Theater Command

Registry information

Official study title

Multi-Omics-Based Development of Novel Thrombosis and Bleeding Markers and Construction of a Risk Prediction Model in Coronary Heart Disease

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

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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