Lipid-lowering Therapy in Patients With High Cardiovascular Risk and Their 3-year Mortality Rate in General Practice in Thailand
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,240
- 试验地点
- 1
- 主要终点
- LDL-cholesterol
研究概览
简要总结
The first phase of the study is a hospital-based cross-sectional, epidemiological survey. The required sample size is 1,260 patients from 50 hospitals across Thailand. Each of the hospital will enroll 10 to 40 consecutive patients, depending on case availability on the date conducting the survey, with dyslipidemia and classified as high risk as defined by the protocol. Lipid levels will be based on serological analysis conducted by a local laboratory.
For the second phase, each subject will be followed for survival status at 36 months after enrollment. Such follow-up will be done by searching the Thai National Vital Event Registration Database using subjects' Population Identification Number. All activities regarding case selection and data collection will be done by well trained clinical research associates (CRAs). The CRAs are from Khon Kaen University where the Statistical Coordinating Center (SCC) for this project is based and are independent of the investigator. Random auditing visits will also be performed by auditors independent of the SCC. These are to ensure not only high quality data but also protecting right and well being of subjects.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Evidence of high cardiovascular risk
- •Dyslipidemic currently being treated with the same therapy for at least 3 months
排除标准
- •Recent major trauma(within 12 weeks)
- •Recent surgery requiring anesthesia including coronary bypass graft(within 12 weeks)
- •Acute or abrupt change(within 1 month) in usual diet
- •Pregnancy, breast-feeding currently, or postpartum within the last 6 months
结局指标
主要结局
LDL-cholesterol
时间窗: June2008
次要结局
- Survival(June 2011)
