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NCT07523880Recruiting

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

Source: ClinicalTrials.gov · Last updated 13 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
12154 (estimated)
First submitted
6 Apr 2026
Start date
1 Aug 2025
Primary completion date
31 Jan 2029
Lead sponsor
Xueyan Zhao
NCT number
NCT07523880

What you commit to

  • Study type: Observational
  • Planned participants: 12154
  • From 1 Aug 2025 to the primary completion date, 31 Jan 2029
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Presence of serious comorbid conditions with life expectancy ≤ 6 months.
  • Conditions that significantly affect study compliance or the ability to complete follow-up.

Other

  • 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:
  • Contraindications to blood sampling.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Coordinator of this site? Confirm its status
BeijingChinaRecruiting
General Hospital of Northern Theater Command of Chinese People's Liberation Army
Coordinator of this site? Confirm its status
ShenyangChinaRecruiting
Fuwai Central China Cardiovascular Hospital
Coordinator of this site? Confirm its status
ZhengzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.