Survey of Lipid Goal Attainment and Mortality in Patients With High Cardiovascular Risk in Thailand
Lipid-lowering Therapy in Patients With High Cardiovascular Risk and Their 3-year Mortality Rate in General Practice in Thailand
1 other identifier
observational
1,240
1 country
49
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2008
Typical duration for all trials
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 22, 2008
CompletedFirst Posted
Study publicly available on registry
May 26, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedDecember 12, 2011
December 1, 2011
May 22, 2008
December 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
LDL-cholesterol
June2008
Secondary Outcomes (1)
Survival
June 2011
Study Arms (1)
1
Patients with high cardiovascular risk who have been treated with lipid-lowering drugs at least 3 months
Eligibility Criteria
Patients with high cardiovascular risk who have been treated with lipid-lowering drugs at least 3 months
You may qualify if:
- Evidence of high cardiovascular risk
- Dyslipidemic currently being treated with the same therapy for at least 3 months
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (49)
Research Site
Kannayao, Bangkok, Thailand
Research Site
Maung, Changwat Ang Thong, Thailand
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Maung, Changwat Chachoengsao, Thailand
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Maung, Changwat Chai Nat, Thailand
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Maung, Changwat Chanthaburi, Thailand
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Maung, Changwat Chumphon, Thailand
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Muang, Changwat Khon Kaen, Thailand
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Maung, Changwat Krabi, Thailand
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Maung, Changwat Lampang, Thailand
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Maung, Changwat Lamphun, Thailand
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Maung, Changwat Lop Buri, Thailand
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Maung, Changwat Nan, Thailand
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Muang, Changwat Nong Khai, Thailand
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Maung, Changwat Nonthaburi, Thailand
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Maung, Changwat Phangnga, Thailand
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Maung, Changwat Phatthalung, Thailand
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Maung, Changwat Phayao, Thailand
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Maung, Changwat Phichit, Thailand
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Maung, Changwat Phitsanulok, Thailand
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Maung, Changwat Phrae, Thailand
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Maung, Changwat Prachuap Khiri Khan, Thailand
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Ban Pong, Changwat Ratchaburi, Thailand
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Maung, Changwat Ratchaburi, Thailand
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Maung, Changwat Rayong, Thailand
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Maung, Changwat Roi Et, Thailand
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Maung, Changwat Samut Sakhon, Thailand
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Maung, Changwat Samut Songkhram, Thailand
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Maung, Changwat Satun, Thailand
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Maung, Changwat Si Sa Ket, Thailand
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Hat Yai, Changwat Songkhla, Thailand
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Maung, Changwat Suphan Buri, Thailand
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Maung, Changwat Surat Thani, Thailand
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Maung, Changwat Surin, Thailand
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Maung, Changwat Tak, Thailand
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Maung, Changwat Trang, Thailand
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Maung, Changwat Ubon Ratchathani, Thailand
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Maung, Changwat Udon Thani, Thailand
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Maung, Chiang Mai, Thailand
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Maung, Kamphaeng Phet H, Thailand
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Maung, Kanchanaburi, Thailand
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Maung, Mahasarakarm, Thailand
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Muang, Nakhorn Phanom, Thailand
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Maung, Nakorn Nayok, Thailand
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Maung, Nokhon Si Thammarat, Thailand
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Maung, Nokorn Pathom, Thailand
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Maung, Phra Nakhon Si Ayutthaya, Thailand
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Maung, Phuket, Thailand
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Maung, Uthaithani, Thailand
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Maung, Uttaradit, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bandit Thinkhamrop, Ph.D
Khon Kaen University
- PRINCIPAL INVESTIGATOR
Songkwan Silaruks, M.D.
Khon Kaen University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2008
First Posted
May 26, 2008
Study Start
April 1, 2008
Study Completion
November 1, 2011
Last Updated
December 12, 2011
Record last verified: 2011-12