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

December 16, 2025 updated by: Xue Yu, Beijing Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

5000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

  • 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;

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One year
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.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

July 31, 2029

Study Completion (Estimated)

July 31, 2029

Study Registration Dates

First Submitted

December 3, 2025

First Submitted That Met QC Criteria

December 16, 2025

First Posted (Actual)

December 19, 2025

Study Record Updates

Last Update Posted (Actual)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 16, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 2025ZD0546402 (Other Grant/Funding Number: Noncommunicable Chronic Diseases-National Science and Technology Major Project)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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