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Rosuvastatin Effect on Telomere-telomerase System in ACS

Primary Purpose

Telomere Shortening, Telomere Length, Mean Leukocyte, 22q Telomere Deletion Syndrome

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
rosuvastatin
Sponsored by
Xiao-dong Zhuang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Telomere Shortening focused on measuring telomere, telomerase, statin, percutaneous coronary intervention, acute coronary syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    randomised to rosuvastatin (20mg/d)

    randomised to rosuvastatin (10mg/d)

    Arm Description

    randomised to rosuvastatin (20mg/d)

    randomised to rosuvastatin (10mg/d)

    Outcomes

    Primary Outcome Measures

    Change from baseline in telomere length after different dose statin treatment
    telomere length of circulating leukocyte will be measured by Southern blot test before and after treatment

    Secondary Outcome Measures

    Change from baseline in telomerase activity after different dose statin treatment
    telomerase activity of circulating leukocyte will be measured by Southern blot test before and after treatment
    PCI-related myocardial infarction (MI)
    PCI related myocardial infarction is defined by the third Universal definition of myocardial infarction

    Full Information

    First Posted
    November 14, 2014
    Last Updated
    July 13, 2015
    Sponsor
    Xiao-dong Zhuang
    Collaborators
    Sun Yat-sen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02299245
    Brief Title
    Rosuvastatin Effect on Telomere-telomerase System in ACS
    Official Title
    Different Doses Rosuvastatin Effect on Telomere-telomerase System in Acute Coronary Syndrome Patients After Percutaneous Coronary INtervention: RETAIN Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2014 (undefined)
    Primary Completion Date
    July 2016 (Anticipated)
    Study Completion Date
    November 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Xiao-dong Zhuang
    Collaborators
    Sun Yat-sen University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Telomere Shortening, Telomere Length, Mean Leukocyte, 22q Telomere Deletion Syndrome
    Keywords
    telomere, telomerase, statin, percutaneous coronary intervention, acute coronary syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    400 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    randomised to rosuvastatin (20mg/d)
    Arm Type
    Experimental
    Arm Description
    randomised to rosuvastatin (20mg/d)
    Arm Title
    randomised to rosuvastatin (10mg/d)
    Arm Type
    Active Comparator
    Arm Description
    randomised to rosuvastatin (10mg/d)
    Intervention Type
    Drug
    Intervention Name(s)
    rosuvastatin
    Other Intervention Name(s)
    Crestor
    Intervention Description
    different dose of rosuvastatin treatment
    Primary Outcome Measure Information:
    Title
    Change from baseline in telomere length after different dose statin treatment
    Description
    telomere length of circulating leukocyte will be measured by Southern blot test before and after treatment
    Time Frame
    baseline; 4 and 24 weeks
    Secondary Outcome Measure Information:
    Title
    Change from baseline in telomerase activity after different dose statin treatment
    Description
    telomerase activity of circulating leukocyte will be measured by Southern blot test before and after treatment
    Time Frame
    baseline; 4 and 24 weeks
    Title
    PCI-related myocardial infarction (MI)
    Description
    PCI related myocardial infarction is defined by the third Universal definition of myocardial infarction
    Time Frame
    PCI-related MI will be assesed within 24 hours after the end of the coronary artery stenting procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

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