NCT02565615已完成不适用
ATORVASTATIN EFFECTIVENESS AND SAFETY IN CARDIOLOGY PATIENTS IN REAL WORLD SETTING: A REGISTRY STUDY IN CHINA
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.53 个研究点 分布在 1 个国家目标入组 5,115 人开始时间: 2016年6月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5,115
- 试验地点
- 53
- 主要终点
- Achievement Rate for Low Density Lipoprotein-Cholesterol (LDL-C) for Overall
研究概览
简要总结
The study is to verify atorvastatin effectiveness and safety in Chinese population, and explore the optimal atorvastatin regimens in high-to-moderate risk for ASCVD。
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
- •Men and women aged ≥18 years;
- •Cardiology patients who has been prescribed atorvastatin by physician's clinical judgment under normal clinical care. These patients will include those with established coronary heart disease, or having multiple risk factors and at risk for cardiovascular disease, or primary hypercholesterolemia.
- •Baseline laboratory reports prior to starting atorvastatin therapy can be tracked , including lipid measurement, liver function, and Creatine Kinase (CK) value. The date of baseline reports should be within 1 month before taking atorvastatin or within 24h after starting atorvastatin therapy.
- •Evidence of a personally or his/her legally acceptable representative signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study and accept follow-up visit.
排除标准
- •Patients who have regularly taken atorvastatin therapy more than 4 weeks before enrollment
- •Concomitant any other lipid-lower medication at baseline, or during the study conduction on physician clinical judgement
结局指标
主要结局
Achievement Rate for Low Density Lipoprotein-Cholesterol (LDL-C) for Overall
时间窗: 12 weeks
Achievement Rate was defined as ratio of number of participants who achieved LDL-C target value to number of participants who completed 12-week follow up.
Achievement Rate for LDL-C by Dose Group Within Each Cardiovascular Disease (CVD) Risk Level
时间窗: 12 weeks
Achievement Rate was defined as ratio of number of participants who achieved LDL-C target value to number of participants who completed 12-week follow up according to the CVD risk stratification. Low-risk: 10 years CVD risk \<5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.
次要结局
- Change From Baseline for Lipid Parameters at Week 12 for Overall(Baseline to Week 12)
- Percent Change From Baseline for Lipid Parameters at Week 12 for Overall(Baseline to Week 12)
- Number of Participants With Adverse Events of Special Interest (AESI) for Overall(Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred:any date during Week 4 to Week 16))
- Number of Participants With Adverse Events of Special Interest (AESI) by Dose Group Within Each CVD Risk Level(Baseline (Day 1) to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16))
- Study Drug Exposure for Overall - Total Dose and Week 12 Dose(Day 1 to Week 12)
- Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level(Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16 ))
- Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST(Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred:any date during Week 4 to Week 16))
- Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level(12 weeks of follow-up)
- Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group(Baseline to Week 12)
- Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk(Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16))
- Change From Baseline for Clinical Laboratory Overall- Creatine Kinase(Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16))
- Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase(Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16))
- Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level(Baseline to Week 12)
- Study Drug Exposure for Overall - Daily Dose(Day 1 to Week 12)
- Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose(Day 1 to Week 12)
- Study Drug Exposure Within Each CVD Risk Group -Daily Dose(Day 1 to Week 12)
- Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) for Overall(Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16 ))
- Number of Participants With Elevated Abnormal Laboratory in Creatine Kinanse (CK), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) for Overall(Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16))
- Change From Baseline for Clinical Laboratory Overall- ALT and AST(Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16))
- Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid(Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16))
- Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid(Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16))
- Precentage of Participants With Discontinuation From the Study for Overall(12 weeks of follow-up)
研究者
研究点 (53)
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