MedPath

Rosuvastatin Effect on Telomere-telomerase System in ACS

Phase 4
Conditions
Telomere Length, Mean Leukocyte
Telomere Shortening
22q Telomere Deletion Syndrome
Interventions
Registration Number
NCT02299245
Lead Sponsor
Xiao-dong Zhuang
Brief Summary

Coronary heart disease (CHD) is one of the diseases characterised by biological aging as one of the important risk factors in several epidemiological studies. The mean telomere length and telomerase activity serve as markers for the biological age at the cellular level, with shorter telomeres and lower telomerase activity defining the increased biological age. Telomere length and telomerase activity, therefore, correlates with the risk of CHD and atherosclerosis. A present study states that the treatment with a statin is associated with a reduction in the number of clinical events but only in individuals with increased risk based on their telomere length. This suggests a positive relationship of telomere and telomerase system with the treatment with statins in CHD patients.

Detailed Description

Coronary heart disease (CHD) is identified as one of the diseases characterised by biological aging as one of the important risk factors in several epidemiological studies. Premature biological aging is distinct from chronological aging and may predispose the individual to myocardial infarction, atherosclerosis and CHD in particular. The mean telomere length and telomerase activity serve as markers for the biological age at the cellular level, with shorter telomeres and lower telomerase activity defining the increased biological age. Telomere length and telomerase activity, therefore, correlates with the risk of CHD and atherosclerosis. Statins serve as the drugs of obvious choice based on their well established efficacy and safety profiles for the treatment of CHD and associated atherosclerosis. A present clinical study states that the treatment with a statin is associated with a reduction in the number of clinical events but only in individuals with increased risk based on their telomere length. This suggests a positive relationship of telomere and telomerase system with the risk of CHD and, therefore, would help clinicians to categorise the patient populations based on their leucocyte telomere length for treatment with statins.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
400
Inclusion Criteria
  • Subjects with ACS, planing for PCI treatment
  • Male or females who are 18-80years of age
  • No current or previous statin therapy
  • No current indication for statin therapy (Coronary artery disease; hypercholesterolemia, renal dysfunction)
  • Subjects who have given their signed consent to participate in the study
Exclusion Criteria
  • Patient < 18 or > 80 years
  • Renal dysfunction
  • Hyperlipidemia
  • Active myositis
  • All forms of liver disease
  • Pregnancy
  • Breastfeeding
  • Patients being treated with other type statin

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
randomised to rosuvastatin (10mg/d)rosuvastatinrandomised to rosuvastatin (10mg/d)
randomised to rosuvastatin (20mg/d)rosuvastatinrandomised to rosuvastatin (20mg/d)
Primary Outcome Measures
NameTimeMethod
Change from baseline in telomere length after different dose statin treatmentbaseline; 4 and 24 weeks

telomere length of circulating leukocyte will be measured by Southern blot test before and after treatment

Secondary Outcome Measures
NameTimeMethod
PCI-related myocardial infarction (MI)PCI-related MI will be assesed within 24 hours after the end of the coronary artery stenting procedure

PCI related myocardial infarction is defined by the third Universal definition of myocardial infarction

Change from baseline in telomerase activity after different dose statin treatmentbaseline; 4 and 24 weeks

telomerase activity of circulating leukocyte will be measured by Southern blot test before and after treatment

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