Comparison of Short- and Long-term Efficacy and Safety Between Ticagrelor and Clopidogrel in Chinese Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9,040
- 试验地点
- 1
- 主要终点
- Composite incidence of vascular death, myocardial infarction and stroke
研究概览
简要总结
This is a prospective, single-center study to assess the long- and short-term outcomes of ticagrelor vs clopidogrel in Chinese patients with acute coronary syndrome undergoing percutaneous coronary intervention. Patients will undergo face-to-face interviews, phone calls, or/and chart reviews at 7 days, 1 month, 6 months and 12 months. When 4500 patients have completed the follow-up, an interim analysis will be performed.
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
- •18 years of age or older;
- •diagnosed as acute coronary syndrome;
- •underwent successful percutaneous coronary intervention.
排除标准
- •participate in any drug clinical trials within 3 months;
- •patients with life-threatening complications, or the researchers determined that the survival time of patients with no more than 1 years;
- •serious neurological disease (Alzheimer's disease, Parkinson syndrome, progressive lower limbs or deaf patients);
- •previous history of cancer or tumor, or pathological examination confirmed precancerous lesions (such as breast ductal carcinoma in situ, or atypical hyperplasia of the cervix);
- •patients refused to comply with the requirements of this study to complete the research work.
结局指标
主要结局
Composite incidence of vascular death, myocardial infarction and stroke
时间窗: up to 12 months
1. Vascular death was defined as death from cardiovascular causes or cerebrovascular causes and any unknown death unless there was another certain cause. 2. The definition of myocardial infarction was consistent with the Third Universal Definition of Myocardial Infarction (1). 3. Stroke was defined as a rapid onset of a new focal loss of neurologic function caused by an ischemic central nervous system event with residual symptoms lasting at least 24 hours from their onset or leading to death.
次要结局
- Composite incidence of all-cause death, myocardial infarction and stroke(up to 12 months)
- Composite incidence of vascular death, myocardial infarction, stroke, recurrent ischemia, transient ischemic attack, or other arterial thrombotic events(up to 12 months)