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

December 9, 2011 updated by: AstraZeneca

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Ang Thong
      • Maung, Ang Thong, Thailand
        • Research Site
    • Ayutthaya
      • Maung, Ayutthaya, Thailand
        • Research Site
    • Bangkok
      • Kannayao, Bangkok, Thailand
        • Research Site
    • Chachoengsao
      • Maung, Chachoengsao, Thailand
        • Research Site
    • Chainat
      • Maung, Chainat, Thailand
        • Research Site
    • Chantaburi
      • Maung, Chantaburi, Thailand
        • Research Site
    • Chiang Mai
      • Maung, Chiang Mai, Thailand
        • Research Site
    • Chumphon
      • Maung, Chumphon, Thailand
        • Research Site
    • Kamphaeng Phet H
      • Maung, Kamphaeng Phet H, Thailand
        • Research Site
    • Kanchanaburi
      • Maung, Kanchanaburi, Thailand
        • Research Site
    • Khon Kaen
      • Muang, Khon Kaen, Thailand
        • Research Site
    • Krabi
      • Maung, Krabi, Thailand
        • Research Site
    • Lampang
      • Maung, Lampang, Thailand
        • Research Site
    • Lamphun
      • Maung, Lamphun, Thailand
        • Research Site
    • Lopburi
      • Maung, Lopburi, Thailand
        • Research Site
    • Mahasarakarm
      • Maung, Mahasarakarm, Thailand
        • Research Site
    • Nakhorn Phanom
      • Muang, Nakhorn Phanom, Thailand
        • Research Site
    • Nakorn Nayok
      • Maung, Nakorn Nayok, Thailand
        • Research Site
    • Nan
      • Maung, Nan, Thailand
        • Research Site
    • Nokhon Si Thammarat
      • Maung, Nokhon Si Thammarat, Thailand
        • Research Site
    • Nokorn Pathom
      • Maung, Nokorn Pathom, Thailand
        • Research Site
    • Nong Khai
      • Muang, Nong Khai, Thailand
        • Research Site
    • Nonthaburi
      • Maung, Nonthaburi, Thailand
        • Research Site
    • Phang Nga
      • Maung, Phang Nga, Thailand
        • Research Site
    • Phatthalung
      • Maung, Phatthalung, Thailand
        • Research Site
    • Phayao
      • Maung, Phayao, Thailand
        • Research Site
    • Phichit
      • Maung, Phichit, Thailand
        • Research Site
    • Phitsanulok
      • Maung, Phitsanulok, Thailand
        • Research Site
    • Phrae
      • Maung, Phrae, Thailand
        • Research Site
    • Phuket
      • Maung, Phuket, Thailand
        • Research Site
    • Prachuap Khiri Khan
      • Maung, Prachuap Khiri Khan, Thailand
        • Research Site
    • Ratchaburi
      • Ban Pong, Ratchaburi, Thailand
        • Research Site
      • Maung, Ratchaburi, Thailand
        • Research Site
    • Rayong
      • Maung, Rayong, Thailand
        • Research Site
    • Roi Et
      • Maung, Roi Et, Thailand
        • Research Site
    • Samut Sakhon
      • Maung, Samut Sakhon, Thailand
        • Research Site
    • Samut songkhram
      • Maung, Samut songkhram, Thailand
        • Research Site
    • Satun
      • Maung, Satun, Thailand
        • Research Site
    • Sisaket
      • Maung, Sisaket, Thailand
        • Research Site
    • Songkhla
      • Hatyai, Songkhla, Thailand
        • Research Site
    • Suphanburi
      • Maung, Suphanburi, Thailand
        • Research Site
    • Surat Thani
      • Maung, Surat Thani, Thailand
        • Research Site
    • Surin
      • Maung, Surin, Thailand
        • Research Site
    • Tak
      • Maung, Tak, Thailand
        • Research Site
    • Trang
      • Maung, Trang, Thailand
        • Research Site
    • Ubon Ratchathani
      • Maung, Ubon Ratchathani, Thailand
        • Research Site
    • Udon Thani
      • Maung, Udon Thani, Thailand
        • Research Site
    • Uthaithani
      • Maung, Uthaithani, Thailand
        • Research Site
    • Uttaradit
      • Maung, Uttaradit, Thailand
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with high cardiovascular risk who have been treated with lipid-lowering drugs at least 3 months

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Patients with high cardiovascular risk who have been treated with lipid-lowering drugs at least 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
LDL-cholesterol
Time Frame: June2008
June2008

Secondary Outcome Measures

Outcome Measure
Time Frame
Survival
Time Frame: June 2011
June 2011

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Bandit Thinkhamrop, Ph.D, Khon Kaen University
  • Principal Investigator: Songkwan Silaruks, M.D., Khon Kaen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

May 22, 2008

First Submitted That Met QC Criteria

May 23, 2008

First Posted (Estimate)

May 26, 2008

Study Record Updates

Last Update Posted (Estimate)

December 12, 2011

Last Update Submitted That Met QC Criteria

December 9, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-CTH-DUM-2007/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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