Association of Genetic Polymorphisms With Lipid Lowering Effects of Statin Therapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00509574
First received: July 29, 2007
Last updated: December 10, 2010
Last verified: November 2010

July 29, 2007
December 10, 2010
March 2007
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00509574 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Association of Genetic Polymorphisms With Lipid Lowering Effects of Statin Therapy
Association of Genetic Polymorphisms With Lipid Lowering Effects of Statin Therapy

The 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors, also known as statins, played an important role in lipid-lowering therapy and reduction of cardiovascular risks. However, it has been observed that the response to statin therapy varies from patient to patient, and gene polymorphism could have contributed to the variation.

Hyperlipidemic patients are retrospectively screened from 2006/1/1 to 2006/12/31. The patient is included if he or she had been receiving atorvastatin or rosuvastatin for at least 3 months and did not receive other lipid-lowering medications 4 weeks before starting atorvastatin or rosuvastatin. Genomic DNA was collected from the blood sample of each patient using genomic DNA purification kit. The single nucleotide polymorphisms (SNPs) were determined afterward.

The correlation between response of statin therapy, defined as changes in lipid profiles including triglyceride, total cholesterol, high density lipoprotein cholesterol and low density lipoprotein cholesterol, and SNPs examined.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

blood samples are obtained for genomic DNA extraction.

Probability Sample

Hyperlipidemic patients meeting the criteria of NCEP ATPIII for drug treatment at internal medicine clinic of National Taiwan University Hospital.

  • Statins, HMG-CoA
  • Single Nucleotide Polymorphism
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
February 2010
Not Provided

Inclusion Criteria:

  • aged 21-80.
  • conforms with the criteria of National Cholesterol Education Program Adult Treatment Panel III for medication therapy.
  • have received atorvastatin or rosuvastatin regularly for 12 weeks or longer.
  • available lipid profiles such triglyceride, total cholesterol, high density lipoprotein cholesterol and low density lipoprotein cholesterol 12-24 weeks after staring statin therapy.

Exclusion Criteria:

  • had been using lipid-lowering medications including statins 4 weeks before starting atorvastatin or rosuvastatin.
  • received other lipid-lowering medications, erythromycin, immunosuppressant or azole antifungals concomitantly.
  • pregnant, breast-feeding, or able to become pregnant.
  • have a history of alcohol or substance abuse.
  • liver cirrhosis or ALT exceeds the upper limit of normal range.
  • untreated hypothyroidism.
  • patients with malignant tumor who have received chemotherapy or radiotherapy.
  • known allergy to atorvastatin, rosuvastatin or other statins.
  • unwilling to provide written informed consent.
Both
21 Years to 80 Years
No
Contact: Tzung-Dau Wang, MD, PhD 886-2-2312-3456 ext 5632 tdwang@ntu.edu.tw
Taiwan
 
NCT00509574
200702006M
No
Tzung-Dau Wang, MD, PhD, National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Principal Investigator: Tzung-Dau Wang, MD, PhD Division of Cardiology, Department of Internal Medicine, National Taiwan University Hospital
National Taiwan University Hospital
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP