Statin-Intolerance Registry
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Number of treatment adjustments
研究概览
简要总结
The Statin-Intolerance Registry will characterize the patient population suffering from statin-intolerance which is a frequent but incompletely understood patient condition with important clinical implications for atherosclerotic cardiovascular disease (ASCVD) prevention.
Patients will be systematically and prospectively included and followed by the registry.
详细描述
This non-interventional registry based on routine clinical practice will collect data under real-life conditions. The treatment of patients will not be changed by this study.
Data on patient characteristics and the treatment history will be collected via questionnaires at study entree. Yearly follow up visits will re-assess the baseline parameters and document cardiovascular events.
The data will be analyzed using descriptive statistics.
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
- •Patients with dyslipidemia and statin intolerance, defined as:
- •Use of 2 or more statins and intolerance of these drugs in any dose or inability to tolerate dosage increasement beyond a maximum weekly dose of 70 mg atorvastatin, 140 mg Simvastatin, pravastatin, or lovastatin, 35 mg rosuvastatin, 280 mg of Fluvastatin and symptoms improve or disappear when statin is reduced in dosage or discontinued
- •Participants are ≧ 18 years old
- •Written declaration of consent is available
- •The patient is cognitively, linguistically and organizationally capable to meet the study requirements. The possibility of 1 year follow-up is very likely.
排除标准
- •Use of any experimental or investigational drugs within 30 days prior to screening.
- •An employee or contractor of the facility conducting the study, or a family member of the principal investigator, co-Investigator, or sponsor.
结局指标
主要结局
Number of treatment adjustments
时间窗: 3 years
Change in LDL cholesterol level
时间窗: 3 years
次要结局
- Change in quality of life(3 years)
- Development of muscle symptoms over time that initially lead to discontinuation of statin therapy(3 years)
研究者
Ulrich Laufs
Prof. Dr. med
University of Leipzig