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临床试验/NCT00684151
NCT00684151已完成不适用

Lipid-lowering Therapy in Patients With High Cardiovascular Risk and Their 3-year Mortality Rate in General Practice in Thailand

AstraZeneca1 个研究点 分布在 1 个国家目标入组 1,240 人开始时间: 2008年4月最近更新:
适应症

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

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)

研究者

发起方
AstraZeneca
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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