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Clinical Trials in China / NCT07523880
Recruiting Observational

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

NCT07523880 · tracked via the Priya Life Science China tracker
Sponsor
Xueyan Zhao
Phase
Observational
Started
2025-08-01
Last updated
2026-04-13

Condition(s) studied

ThrombosisBleedingCoronary Artery Disease (CAD)

Study 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.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

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

Trial sites (3)

FacilityCityRegionStatus
Fuwai Central China Cardiovascular Hospital Zhengzhou Henan Recruiting
General Hospital of Northern Theater Command of Chinese People's Liberation Army Shenyang Liaoning Recruiting
Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Beijing China Recruiting

Other trials for the same condition

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Micro-axial Flow Pump-Supported PCI in Complex Coronary Artery Disease With Ischemic LV Dysfunction Starting soon
Intravenous Thrombolytic Therapy for Acute Ischemic Stroke Patients with Low NIHSS and Non-disabling Deficits Starting soon
Desflurane Potentially Induces Postoperative Cognitive Dysfunction in Elderly Patients Undergoing Perioperative Procedures by Modulating Cdc42 and Clock Proteins Starting soon
Clinical Study on Emergency Treatment of Cerebral Arteriovenous Malformation Bleeding Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07523880 on ClinicalTrials.gov ↗ ← All trials in China