Austrian Cholesterol Screening And Treatment II (ACT II)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,682
- 主要终点
- Number of Participants Achieving Individual LDL Cholesterol (LDL-C) Target Level
研究概览
简要总结
This non-interventional longitudinal study is a follow-up of the Austrian Cholesterol Screening and Treatment project (ACT I), which assessed the cholesterol status, including achievement of the target levels applicable at that time (LDL levels <100 mg/dL), in participants with coronary heart disease (CHD) already being treated with a statin. In this study, participants without adequate LDL-cholesterol reduction with a statin underwent extension of therapy with ezetimibe with the goal of achieving target levels.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
All participants
Participants in whom LDL-C target levels have not been achieved and for whom ezetimibe therapy has been chosen.
干预措施: Ezetimibe (Drug)
结局指标
主要结局
Number of Participants Achieving Individual LDL Cholesterol (LDL-C) Target Level
时间窗: Up to 12 months
Individual LDL-C target values were set according to the Austrian Cholesterol Consensus (ACC) 2007 for patients for patients suffering from coronary heart disease (CHD) or CHD equivalent in an office-based, routine medical care setting. Participants were categorized as either high-risk or very high-risk based on ACC criteria. The LDL-C target levels for each category were 100 mg/dL and 70 mg/dL, respectively
次要结局
- Change From Baseline in Total Cholesterol (TC) at Month 3(Baseline and Month 3)
- Change From Baseline in LDL-C at Month 3(Baseline and Month 3)
- Change From Baseline in TC at Month 12(Baseline and Month 12)
- Change From Baseline in LDL-C at Month 12(Baseline and Month 12)
- Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Month 3(Baseline and Month 3)
- Change From Baseline in HDL-C at Month 12(Baseline and Month 12)
- Change From Baseline in Triglycerides (TG) at Month 3(Baseline and Month 3)
- Change From Baseline in TG at Month 12(Baseline and Month 12)