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

NCT ID: NCT00684151

Last Updated: 2011-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2011-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Dyslipidemia

Keywords

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Lipid-lowering

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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1

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bandit Thinkhamrop, Ph.D

Role: STUDY_DIRECTOR

Khon Kaen University

Songkwan Silaruks, M.D.

Role: PRINCIPAL_INVESTIGATOR

Khon Kaen University

Locations

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Research Site

Kannayao, Bangkok, Thailand

Site Status

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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

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Countries

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Thailand

Other Identifiers

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NIS-CTH-DUM-2007/1

Identifier Type: -

Identifier Source: org_study_id