A Study of Clinical Outcomes in Patients With Myocardial Infarction Who Maintained Novel Antiplatelet Agents for 1 Year and Patients Who Switched to Clopidogrel Early
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Composite of all-cause death, recurrent myocardial infarction, stroke, (ischemic and hemorrhagic ) and bleeding within one year.
研究概览
简要总结
Myocardial infarction is defined according to icd-10 using the data base of South korea National Health Insurance Corporation, where personal identification information has already been removed, and detailed results are derived for each drug category.
详细描述
The purpose of this study is to compare the prognosis of patients with clopidogrel after early discontinuation of ticagrelor/prasugrel with patients who maintained aspirin and ticagrelor/prasugrel as standard therapy in patients with acute myocardial infarction who underwent percutaneous coronary intervention.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Patients who have a diagnosis code for acute myocardial infarction indicated in the National Health Insurance data and data for drugs that have used ticagrelor/prasugrel for 30-90 days when hospitalized for the relevant disease.
- •Patients who switched to clopidogrel after 30-90 days.
- •Patients with a diagnosis code for Venus myocardial infarction and a prescription code for percutaneous cardiovascular intervention in the National Health Insurance data.
- •Adults 18 years of age or older
排除标准
- •A person who has data for requesting blood transfusion during the period of hospitalization in the National Health Insurance data
- •Those who have data for oral anticoagulants (warfarin, Coumadin, apixaban, edoxaban, dabigatran, rivaroxaban) in the National Health Insurance data
- •Those who have a diagnosis code for malignant tumor in the National Health Insurance data
- •Those who have end-stage renal failure code in the National Health Insurance data or those who have data for hemo/peritoneal dialysis
- •A person who has a request for blood transfusion during the period of using Ticagrelor/prasugrel
结局指标
主要结局
Composite of all-cause death, recurrent myocardial infarction, stroke, (ischemic and hemorrhagic ) and bleeding within one year.
时间窗: Percutaneous coronary intervention after 1 Year
compared patients who maintained ticagrelor/Prasugrel with those who switched from ticagrelor/prasugrel to clopidogrel. * All cause death * Myocardial infarction * Stroke * Bleeding Categorical data is indicated by number (%) and analyzed by X2 statistics. Continuous variables are expressed as mean standard deviation (±SD) , and in the case of skewed distribution, comparison is made by Mann-Whitney test or Student t test. To balance differences in baseline characteristics, stabilized inverse probability of treatment weighting (sIPTW) is used. For further analysis, consider propensity score matching (PSM) with nearest neighbor method and standardized mortality ratio weighting (SMRW) estimation. Propensity score uses a generalized additive logistic model and considers demographic data (age, gender, hypertension, diabetes mellitus, heart failure hemodialysis).
次要结局
未报告次要终点
研究者
Chan Joon Kim
professor
Uijeongbu St. Mary Hospital