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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00684151
First Posted: May 26, 2008
Last Update Posted: December 12, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  Purpose

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.


Condition
Dyslipidemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Lipid-lowering Therapy in Patients With High Cardiovascular Risk and Their 3-year Mortality Rate in General Practice in Thailand

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • LDL-cholesterol [ Time Frame: June2008 ]

Secondary Outcome Measures:
  • Survival [ Time Frame: June 2011 ]

Enrollment: 1240
Study Start Date: April 2008
Study Completion Date: November 2011
Groups/Cohorts
1
Patients with high cardiovascular risk who have been treated with lipid-lowering drugs at least 3 months

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with high cardiovascular risk who have been treated with lipid-lowering drugs at least 3 months
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00684151


  Show 49 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Bandit Thinkhamrop, Ph.D Khon Kaen University
Principal Investigator: Songkwan Silaruks, M.D. Khon Kaen University
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00684151     History of Changes
Other Study ID Numbers: NIS-CTH-DUM-2007/1
First Submitted: May 22, 2008
First Posted: May 26, 2008
Last Update Posted: December 12, 2011
Last Verified: December 2011

Keywords provided by AstraZeneca:
Lipid-lowering

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases