Rosuvastatin Effect on Telomere-telomerase System in ACS

Overview

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.

Full Title of Study: “Different Doses Rosuvastatin Effect on Telomere-telomerase System in Acute Coronary Syndrome Patients After Percutaneous Coronary INtervention: RETAIN Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2016

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.

Interventions

  • Drug: rosuvastatin
    • different dose of rosuvastatin treatment

Arms, Groups and Cohorts

  • Experimental: randomised to rosuvastatin (20mg/d)
    • randomised to rosuvastatin (20mg/d)
  • Active Comparator: randomised to rosuvastatin (10mg/d)
    • randomised to rosuvastatin (10mg/d)

Clinical Trial Outcome Measures

Primary Measures

  • Change from baseline in telomere length after different dose statin treatment
    • Time Frame: baseline; 4 and 24 weeks
    • telomere length of circulating leukocyte will be measured by Southern blot test before and after treatment

Secondary Measures

  • Change from baseline in telomerase activity after different dose statin treatment
    • Time Frame: baseline; 4 and 24 weeks
    • telomerase activity of circulating leukocyte will be measured by Southern blot test before and after treatment
  • PCI-related myocardial infarction (MI)
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Xiao-dong Zhuang
  • Collaborator
    • Sun Yat-sen University
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Xiao-dong Zhuang, director of the department of cardiology – Sun Yat-sen University

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