DyslipidemiaNCT00684151
Survey of Lipid Goal Attainment and Mortality in Patients With High Cardiovascular Risk in Thailand
An observational study of Dyslipidemia, run by AstraZeneca at 49 sites in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Dyslipidemia
- How many people
- 1,240 participants
- Where
- 49 sitesThailand
- Study dates
- Apr 2008to Nov 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with high cardiovascular risk who have been treated with lipid-lowering drugs at least 3 months
Who may be able to join
- Evidence of high cardiovascular risk
- Dyslipidemic currently being treated with the same therapy for at least 3 months
Who cannot join
- 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
Trial locations and contacts
49 sites in 1 country.
49 sites in 1 country
Thailand49 sites
Research Site
Ban Pong, Changwat Ratchaburi
Research Site
Hat Yai, Changwat Songkhla
Research Site
Kannayao, Bangkok
Research Site
Maung, Changwat Ang Thong
Research Site
Maung, Changwat Chachoengsao
Research Site
Maung, Changwat Chai Nat
Research Site
Maung, Changwat Chanthaburi
Research Site
Maung, Changwat Chumphon
Research Site
Maung, Changwat Krabi
Research Site
Maung, Changwat Lampang
Research Site
Maung, Changwat Lamphun
Research Site
Maung, Changwat Lop Buri
Research Site
Maung, Changwat Nan
Research Site
Maung, Changwat Nonthaburi
Research Site
Maung, Changwat Phangnga
Research Site
Maung, Changwat Phatthalung
Research Site
Maung, Changwat Phayao
Research Site
Maung, Changwat Phichit
Research Site
Maung, Changwat Phitsanulok
Research Site
Maung, Changwat Phrae
Research Site
Maung, Changwat Prachuap Khiri Khan
Research Site
Maung, Changwat Ratchaburi
Research Site
Maung, Changwat Rayong
Research Site
Maung, Changwat Roi Et
Research Site
Maung, Changwat Samut Sakhon
Research Site
Maung, Changwat Samut Songkhram
Research Site
Maung, Changwat Satun
Research Site
Maung, Changwat Si Sa Ket
Research Site
Maung, Changwat Suphan Buri
Research Site
Maung, Changwat Surat Thani
Research Site
Maung, Changwat Surin
Research Site
Maung, Changwat Tak
Research Site
Maung, Changwat Trang
Research Site
Maung, Changwat Ubon Ratchathani
Research Site
Maung, Changwat Udon Thani
Research Site
Maung, Chiang Mai
Research Site
Maung, Kamphaeng Phet H
Research Site
Maung, Kanchanaburi
Research Site
Maung, Mahasarakarm
Research Site
Maung, Nakorn Nayok
Research Site
Maung, Nokhon Si Thammarat
Research Site
Maung, Nokorn Pathom
Research Site
Maung, Phra Nakhon Si Ayutthaya
Research Site
Maung, Phuket
Research Site
Maung, Uthaithani
Research Site
Maung, Uttaradit
Research Site
Muang, Changwat Khon Kaen
Research Site
Muang, Changwat Nong Khai
Research Site
Muang, Nakhorn Phanom
About this study
Official title: 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.
- Conditions
- Dyslipidemia
- Keywords
- Lipid-lowering
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with high cardiovascular risk who have been treated with lipid-lowering drugs at least 3 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-cholesterol
Measured: June2008
Secondary outcomes (1)
Survival
Measured: June 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2008 (estimated)
- Study startApr 2008
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,240 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bandit Thinkhamrop, Ph.D, Study director, Khon Kaen UniversitySongkwan Silaruks, M.D., Principal investigator, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00684151
- Sponsor's protocol ID
- NIS-CTH-DUM-2007/1
- Status last verified
- Dec 2011
- First submitted
- 22 May 2008
- Last updated
- 12 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipid-lowering Therapy in Patients With High Cardiovascular Risk and Their 3-year Mortality Rate in General Practice in Thailand
- ClinicalTrials.gov ID
- NCT00684151
- Acronym / sponsor ID
- NIS-CTH-DUM-2007/1
- Conditions
- Dyslipidemia
- Keywords
- Lipid-lowering
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,240 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Study completion
- Nov 2011 (actual)
- First posted
- 26 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with high cardiovascular risk who have been treated with lipid-lowering drugs at least 3 months |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with high cardiovascular risk who have been treated with lipid-lowering drugs at least 3 months
Key inclusion criteria (2 listed)
- Evidence of high cardiovascular risk
- Dyslipidemic currently being treated with the same therapy for at least 3 months
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
LDL-cholesterol
Time frame: June2008
1 secondary outcome
Survival
Time frame: June 2011
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2011.
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A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bandit Thinkhamrop, Ph.D study director
Khon Kaen University
Songkwan Silaruks, M.D. principal investigator
Khon Kaen University
49 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyslipidemia, run by AstraZeneca at 49 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL-cholesterol (time frame: June2008). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2011.