Dyslipidemia Clinical Trial
Official title:
Lipid-lowering Therapy in Patients With High Cardiovascular Risk and Their 3-year Mortality Rate in General Practice in Thailand
| Verified date | December 2011 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Thailand: Ministry of Public Health |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 1240 |
| Est. completion date | November 2011 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 80 Years |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| Thailand | Research Site | Ban Pong | Ratchaburi |
| Thailand | Research Site | Hatyai | Songkhla |
| Thailand | Research Site | Kannayao | Bangkok |
| Thailand | Research Site | Maung | Chachoengsao |
| Thailand | Research Site | Maung | Chainat |
| Thailand | Research Site | Maung | Chantaburi |
| Thailand | Research Site | Maung | Chiang Mai |
| Thailand | Research Site | Maung | Chumphon |
| Thailand | Research Site | Maung | Kamphaeng Phet H |
| Thailand | Research Site | Maung | Kanchanaburi |
| Thailand | Research Site | Maung | Krabi |
| Thailand | Research Site | Maung | Lampang |
| Thailand | Research Site | Maung | Lamphun |
| Thailand | Research Site | Maung | Lopburi |
| Thailand | Research Site | Maung | Mahasarakarm |
| Thailand | Research Site | Maung | Nakorn Nayok |
| Thailand | Research Site | Maung | Nan |
| Thailand | Research Site | Maung | Nokhon Si Thammarat |
| Thailand | Research Site | Maung | Nokorn Pathom |
| Thailand | Research Site | Maung | Ratchaburi |
| Thailand | Research Site | Maung | Rayong |
| Thailand | Research Site | Maung | Roi Et |
| Thailand | Research Site | Maung | Samut Sakhon |
| Thailand | Research Site | Maung | Samut songkhram |
| Thailand | Research Site | Maung | Satun |
| Thailand | Research Site | Maung | Sisaket |
| Thailand | Research Site | Maung | Nonthaburi |
| Thailand | Research Site | Maung | Phang Nga |
| Thailand | Research Site | Maung | Phatthalung |
| Thailand | Research Site | Maung | Phayao |
| Thailand | Research Site | Maung | Phichit |
| Thailand | Research Site | Maung | Phitsanulok |
| Thailand | Research Site | Maung | Phrae |
| Thailand | Research Site | Maung | Phuket |
| Thailand | Research Site | Maung | Prachuap Khiri Khan |
| Thailand | Research Site | Maung | Suphanburi |
| Thailand | Research Site | Maung | Surat Thani |
| Thailand | Research Site | Maung | Surin |
| Thailand | Research Site | Maung | Tak |
| Thailand | Research Site | Maung | Trang |
| Thailand | Research Site | Maung | Ubon Ratchathani |
| Thailand | Research Site | Maung | Udon Thani |
| Thailand | Research Site | Maung | Uthaithani |
| Thailand | Research Site | Maung | Uttaradit |
| Thailand | Research Site | Maung | Ang Thong |
| Thailand | Research Site | Maung | Ayutthaya |
| Thailand | Research Site | Muang | Nong Khai |
| Thailand | Research Site | Muang | Nakhorn Phanom |
| Thailand | Research Site | Muang | Khon Kaen |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | LDL-cholesterol | June2008 | No | |
| Secondary | Survival | June 2011 | No |
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