Clinical trial NCT00684151: Survey of Lipid Goal Attainment and Mortality in Patients With High Cardiovascular Risk in Thailand
Official title: Lipid-lowering Therapy in Patients With High Cardiovascular Risk and Their 3-year Mortality Rate in General Practice in Thailand
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyslipidemia
Keywords: Lipid-lowering
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-05-26
Enrollment: 1240
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with high cardiovascular risk who have been treated with lipid-lowering drugs at least 3 months

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.


Eligibility 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

Primary outcomes:
measure: LDL-cholesterol
timeFrame: June2008
Secondary outcomes:
measure: Survival
timeFrame: June 2011
Other outcomes:
Locations:
city: Maung
country: Thailand
facility: Research Site
state: Ang Thong
city: Maung
country: Thailand
facility: Research Site
state: Ayutthaya
city: Kannayao
country: Thailand
facility: Research Site
state: Bangkok
city: Maung
country: Thailand
facility: Research Site
state: Chachoengsao
city: Maung
country: Thailand
facility: Research Site
state: Chainat
city: Maung
country: Thailand
facility: Research Site
state: Chantaburi
city: Maung
country: Thailand
facility: Research Site
state: Chiang Mai
city: Maung
country: Thailand
facility: Research Site
state: Chumphon
city: Maung
country: Thailand
facility: Research Site
state: Kamphaeng Phet H
city: Maung
country: Thailand
facility: Research Site
state: Kanchanaburi
city: Muang
country: Thailand
facility: Research Site
state: Khon Kaen
city: Maung
country: Thailand
facility: Research Site
state: Krabi
city: Maung
country: Thailand
facility: Research Site
state: Lampang
city: Maung
country: Thailand
facility: Research Site
state: Lamphun
city: Maung
country: Thailand
facility: Research Site
state: Lopburi
city: Maung
country: Thailand
facility: Research Site
state: Mahasarakarm
city: Muang
country: Thailand
facility: Research Site
state: Nakhorn Phanom
city: Maung
country: Thailand
facility: Research Site
state: Nakorn Nayok
city: Maung
country: Thailand
facility: Research Site
state: Nan
city: Maung
country: Thailand
facility: Research Site
state: Nokhon Si Thammarat
city: Maung
country: Thailand
facility: Research Site
state: Nokorn Pathom
city: Muang
country: Thailand
facility: Research Site
state: Nong Khai
city: Maung
country: Thailand
facility: Research Site
state: Nonthaburi
city: Maung
country: Thailand
facility: Research Site
state: Phang Nga
city: Maung
country: Thailand
facility: Research Site
state: Phatthalung
city: Maung
country: Thailand
facility: Research Site
state: Phayao
city: Maung
country: Thailand
facility: Research Site
state: Phichit
city: Maung
country: Thailand
facility: Research Site
state: Phitsanulok
city: Maung
country: Thailand
facility: Research Site
state: Phrae
city: Maung
country: Thailand
facility: Research Site
state: Phuket
city: Maung
country: Thailand
facility: Research Site
state: Prachuap Khiri Khan
city: Ban Pong
country: Thailand
facility: Research Site
state: Ratchaburi
city: Maung
country: Thailand
facility: Research Site
state: Ratchaburi
city: Maung
country: Thailand
facility: Research Site
state: Rayong
city: Maung
country: Thailand
facility: Research Site
state: Roi Et
city: Maung
country: Thailand
facility: Research Site
state: Samut Sakhon
city: Maung
country: Thailand
facility: Research Site
state: Samut songkhram
city: Maung
country: Thailand
facility: Research Site
state: Satun
city: Maung
country: Thailand
facility: Research Site
state: Sisaket
city: Hatyai
country: Thailand
facility: Research Site
state: Songkhla
city: Maung
country: Thailand
facility: Research Site
state: Suphanburi
city: Maung
country: Thailand
facility: Research Site
state: Surat Thani
city: Maung
country: Thailand
facility: Research Site
state: Surin
city: Maung
country: Thailand
facility: Research Site
state: Tak
city: Maung
country: Thailand
facility: Research Site
state: Trang
city: Maung
country: Thailand
facility: Research Site
state: Ubon Ratchathani
city: Maung
country: Thailand
facility: Research Site
state: Udon Thani
city: Maung
country: Thailand
facility: Research Site
state: Uthaithani
city: Maung
country: Thailand
facility: Research Site
state: Uttaradit
Study officials:
affiliation: Khon Kaen University
name: Bandit Thinkhamrop, Ph.D
role: STUDY_DIRECTOR
affiliation: Khon Kaen University
name: Songkwan Silaruks, M.D.
role: PRINCIPAL_INVESTIGATOR
References: