The Association of Genetic Polymorphisms With Statin-Induced Myopathy.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00549029
First received: October 24, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted

October 24, 2007
October 24, 2007
August 2007
Not Provided
genotype of specific genes [ Time Frame: one day ]
Same as current
No Changes Posted
single nucleotide polymorphism [ Time Frame: one day ]
Same as current
Not Provided
Not Provided
 
The Association of Genetic Polymorphisms With Statin-Induced Myopathy.
Association Analysis Between Single Nucleotide Polymorphisms in Statin-Related Genes and The Incidence of Myopathy Among Statin-Treated Patients

To observe not only the distribution of single nucleotide polymorphism in genes related with pharmacodynamic and pharmacokinetics alteration of statins but also to analyze the correlation between these SNPs and the incidence of statins-induced myopathy.

Statins are widely prescribed for the patients with hypercholesterolemia.

Though their efficacy in preventing cardiovascular events has been shown by a large number of clinical trials, myotoxic side effects including myopathy or even more severe,rhabdomyolysis are associated with the use of statins.

Because the incidence of myopathy is various among individuals,polymorphism in genes is supposed to be the main factor.

Due to single nucleotide polymorphism in related genes,level of uptake, clearance and metabolism of statins can be seriously different among individuals resulting in various occurrence of myopathy.

Therefore, analytical study in association between SNP of statins-related genes and the incidence of myopathy is such a critical research which can be applied into clinical fields.

Observational
Observational Model: Case Control
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

whole blood

Probability Sample

National Taiwan University Hospital

  • Rhabdomyolysis
  • Myopathy
Genetic: DNA
withdraw 5~10mL blood from vein only once during the whole design
1,2
Group 1 for the patients with rhabdomyolysis Group 2 for the control without any myopathy
Intervention: Genetic: DNA
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
January 2008
Not Provided

Inclusion Criteria:

  • Clinical diagnosis of Rhabdomyolysis because of prescription with statins

Exclusion Criteria:

  • Carnitine palmityl transferase ll deficiency
  • McArdle disease
  • Myoadenylate deaminase deficiency
Both
21 Years to 80 Years
Yes
Contact: Yen-Hui Chen, PhD 886-2-2312-3456 ext 8397 tcyhchen@ntu.edu.tw
Contact: Tzung-Dau Wang, PhD 886-2-2312-3456 ext 5632 tdwang@ntu.edu.tw
Taiwan
 
NCT00549029
200708077R
No
Not Provided
National Taiwan University Hospital
Not Provided
Study Director: Yen-Hui Chen, PhD National Taiwan Univesity College of Medicine
National Taiwan University Hospital
October 2007

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