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NCT Number: NCT07295665

External Validation of Ischemia and Hemorrhage Risk Models in Patients With Coronary Heart Disease

Thrombosis formation is the core mechanism for the occurrence of major adverse cardiovascular and cerebrovascular events in patients with coronary heart disease. Antithrombotic therapy is one of the most important treatment methods for secondary prevention of coronary heart disease. Antithrombotic drugs, while reducing ischemic events, often significantly increase the risk of bleeding. How to balance the risk of recurrent ischemic events and bleeding events in patients with coronary heart disease is a major challenge in the treatment of coronary heart disease. This project establishes a high-quality multicenter, prospective coronary heart disease cohort, with patients covering various clinical characteristics such as different regions, ages, and comorbidities. It verifies the ischemic risk and bleeding risk model developed in Project 1, compares the efficacy improvement of the new model with the traditional risk model, and verifies the effectiveness and stability of the model in different subgroups of the population, and assesses the generalizability of the model in real-world clinical practice, providing high-quality evidence-based basis for the formulation of individualized and precise antithrombotic strategies for coronary heart disease.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years old;
  • Patients with clinically diagnosed various types of coronary heart disease, who are scheduled to receive long-term antithrombotic treatment;
  • Patients with acute coronary syndrome or those who have undergone coronary intervention therapy, whose condition must be stable after treatment and meet the discharge criterias;

Exclusion criteria

  • Combination of severe non-cardiovascular diseases: Expected lifespan does not exceed 6 months, such as patients with advanced cancer or other terminal diseases;
  • Unable to cooperate with long-term follow-up: Such as patients with severe cognitive impairment or severe mental illness;
  • Non-cardiovascular death within 24 hours after admission.

Treatment and study plan

Ischemic risk and bleeding risk model

Diagnostic Test

This study verifies the ischemic risk and bleeding risk model developed in Project 1, compares the efficacy improvement of the new model with the traditional risk model, and verifies the effectiveness and stability of the model in different subgroups of the population, and assesses the generalizability of the model in real-world clinical practice, providing high-quality evidence-based basis for the formulation of individualized and precise antithrombotic strategies for coronary heart disease.

Primary outcomes

  1. The primary efficacy endpoint

    Time frame: One year

    The primary efficacy endpoint is the major cardiovascular and cerebrovascular ischemic event (MACCE) during the 1-year follow-up period, which includes all-cause mortality, non-fatal myocardial infarction, unplanned revascularization, and stroke.

  2. The primary safety endpoint

    Time frame: One year

    The primary safety endpoint is the major bleeding event (BARC type 3 and 5) during the 1-year follow-up period.

Sponsors and collaborators

Lead sponsor

Beijing Hospital

Other Gov

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Dec 19, 2025
Registry last updated
Dec 19, 2025

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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