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Rosuvastatin Effect on Telomere-telomerase System in ACS

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ClinicalTrials.gov Identifier: NCT02299245
Recruitment Status : Unknown
Verified July 2015 by Xiao-dong Zhuang, Sun Yat-sen University.
Recruitment status was:  Active, not recruiting
First Posted : November 24, 2014
Last Update Posted : July 14, 2015
Sponsor:
Collaborator:
Sun Yat-sen University
Information provided by (Responsible Party):
Xiao-dong Zhuang, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Telomere Shortening Telomere Length, Mean Leukocyte 22q Telomere Deletion Syndrome Drug: rosuvastatin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Different Doses Rosuvastatin Effect on Telomere-telomerase System in Acute Coronary Syndrome Patients After Percutaneous Coronary INtervention: RETAIN Study
Study Start Date : October 2014
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: randomised to rosuvastatin (20mg/d)
randomised to rosuvastatin (20mg/d)
Drug: rosuvastatin
different dose of rosuvastatin treatment
Other Name: Crestor

Active Comparator: randomised to rosuvastatin (10mg/d)
randomised to rosuvastatin (10mg/d)
Drug: rosuvastatin
different dose of rosuvastatin treatment
Other Name: Crestor




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Xiao-dong Zhuang, director of the department of cardiology, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02299245     History of Changes
Other Study ID Numbers: RETAIN Study
First Posted: November 24, 2014    Key Record Dates
Last Update Posted: July 14, 2015
Last Verified: July 2015

Keywords provided by Xiao-dong Zhuang, Sun Yat-sen University:
telomere
telomerase
statin
percutaneous coronary intervention
acute coronary syndrome

Additional relevant MeSH terms:
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Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors