External Validation of Ischemia and Hemorrhage Risk Models in Patients With Coronary Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 5,000
- 主要终点
- The primary efficacy endpoint
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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.
结局指标
主要结局
The primary efficacy endpoint
时间窗: 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.
The primary safety endpoint
时间窗: One year
The primary safety endpoint is the major bleeding event (BARC type 3 and 5) during the 1-year follow-up period.
次要结局
未报告次要终点
研究者
Xue Yu
Director of the Department of Cardiology
Beijing Hospital