NCT05174143已完成不适用
Personalized Antiplatelet Therapy According to CYP2C19 Genotype in Coronary Artery Disease: A Real World Study
Xinjiang Medical University0 个研究点目标入组 15,000 人开始时间: 2016年12月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15,000
- 主要终点
- bleeding events
研究概览
简要总结
This study is a prospective, no-randomized, single-center study performed on 15000 consecutive coronary artery patients from Dec. 2016 to Oct. 2021. All these patients were detected CYP2C19 genotype. The antiplatelet treatment was recorded according to the therapy actually adopted by the patients.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Aged >18 years old;
- •Coronary angiography confirmed that there was at least one coronary artery stenosis >70%; or the degree of stenosis of the left main artery stenosis >50%;
- •At least one clinical phenotype of coronary heart disease is present: stable angina or acute coronary syndrome 4.To be able to sign informed consent.
排除标准
- •Combined with severe valvular heart disease;
- •Combined with severe congenital heart disease;
- •Combined hyperthyroidism, anemia and other high-powered heart disease;
- •With pulmonary heart disease;
- •With hypertrophic obstructive cardiomyopathy;
- •Severe hypotension (SBP <90mmHg or DBP <60mmHg at enrollment);
- •Liver dysfunction (defined as ALT or total bilirubin is greater than the normal upper limit of 3 times);
- •Renal insufficiency (defined as serum creatinine greater than 1.5 times the normal upper limit);
- •High-risk bleeding patients, such as thrombocytopenia, blood diseases and other diseases;
- •active peptic ulcer and skin ulcers;
- •A patient who is allergic to clopidogrel, Ticagrelor, or aspirin;
- •Patients with a history of cardiogenic shock within two weeks;
- •pregnant and lactating women, during treatment can not be strict contraception of women of childbearing age;
- •In the past 3 months participated in other clinical researchers;
- •Persons who do not have legal or legal competence;
- •Any condition that the investigator considers unsuitable for participation in the clinical study.
结局指标
主要结局
bleeding events
时间窗: 5 years
BARC class 2 or higher bleeding events
Mortality
时间窗: 5 years
All-cause death and cardiac death
Net clinical adverse events
时间窗: 5 years
a composite of cardiac death, myocardial infarction (MI), revascularization, and bleeding (Bleeding Academic Research Consortium (BARC) definitions, type 2, 3, or 5),
次要结局
- cardiac death(5 years)
- all-cause death(5 years)
- stent thrombosis(5 years)
- myocardial infarction(5 years)
- major adverse cardiovascular events (MACE)(5 years)
- stroke(5 years)
- major adverse cardiovascular and cerebrovascular events (MACCE)(5 years)
- urgent revascularization(5 years)
研究者
Xiang Xie
Professor
Xinjiang Medical University
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