AssessmeNt of Efficacy of Low-dose rosuvaStatin in KoRean 4 Statin Benefit Groups Per 2013 ACC/AHA Guideline
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 242
- 主要终点
- Percentage reduction in low-density lipoprotein (LDL) cholesterol
研究概览
简要总结
This study aimed to evaluate the efficacy of low-dose rosuvastatin (10 mg) in the 4 statin benefit groups requiring high- or moderate-intensity statin therapy according to the 2013 American College of Cardiology/American Heart Association guideline in Korean population.
详细描述
The primary endpoint was percentage reduction in low-density lipoprotein (LDL) cholesterol. Secondary endpoints were percentage reduction in other lipids and achievement of ≥50% reduction in LDL cholesterol. Intention-to-treat analyses were performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects with prior history of clinical ASCVD
- •subjects with primary elevation of LDL cholesterol ≥190 mg/dL
- •subjects with diabetes, age 40 to 75 years, and LDL cholesterol 70 to 189 mg/dL
- •subjects without diabetes, age 40 to 75 years, LDL cholesterol 70 to 189 mg/dL, and with estimated 10-year ASCVD risk ≥7.5%.
排除标准
- •history of significant statin-induced rhabdomyolysis or myopathy
- •history of a significant hypersensitivity reaction to rosuvastatin
- •uncontrolled diabetes mellitus (HbA1c >9%)
- •uncontrolled hypertension (systolic blood pressure >190 mmHg or diastolic blood pressure >100 mmHg)
- •current active liver disease (alanine aminotransferase and/or aspartate aminotransferase >2 times the upper limit of normal)
- •chronic kidney disease (serum creatinine clearance <30 ml/min)
- •creatine kinase levels >3 times the upper limit of normal
- •use of prohibited concomitant therapies
- •history of malignancy within the last 5 years
- •women who were pregnant, breast-feeding or of childbearing potential without contraception
- •subjects who would take any medication for purposes other than this trial within 30 days after taking this study's medication.
研究组 & 干预措施
Low-dose (10mg) rosuvastatin
Four statin benefit groups per 2013 ACC/AHA guideline in Korea
干预措施: Low-dose (10mg) rosuvastatin (Drug)
结局指标
主要结局
Percentage reduction in low-density lipoprotein (LDL) cholesterol
时间窗: 8 weeks
Percentage reduction in low-density lipoprotein (LDL) cholesterol from baseline to 8 weeks of treatment
次要结局
- Achievement of ≥50% reduction in LDL cholesterol(8 weeks)
- Percentage reduction in other lipids(8 weeks)
研究者
Hyo-Soo Kim
Professor, Department of Internal Medicine
Seoul National University Hospital