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OpenTrials
Completed

NCT Number: NCT00684151

Survey of Lipid Goal Attainment and Mortality in Patients With High Cardiovascular Risk in Thailand

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Kannayao, Bangkok, Thailand

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Evidence of high cardiovascular risk
  • Dyslipidemic currently being treated with the same therapy for at least 3 months

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. LDL-cholesterol

    Time frame: June2008

Secondary outcomes

  1. Survival

    Time frame: June 2011

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Study completion
2011
First posted
May 26, 2008
Registry last updated
Dec 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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