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

NCT07295665 | Not Yet Recruiting

• 1 other identifier: 2025ZD0546402
• Study Type: observational
• Target: 5,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Coronary Arterial Disease (CAD)

Outcome Measures

Primary Outcomes (2)

• The primary efficacy endpoint

  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

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

  One year

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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;

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Hospital: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Cardiology

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 19, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: December 19, 2025

Record last verified: 2025-12