Rosuvastatin Effect on Telomere-telomerase System in ACS

July 13, 2015 updated by: Xiao-dong Zhuang

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: randomised to rosuvastatin (20mg/d)
Drug: rosuvastatin
different dose of rosuvastatin treatment
Other Names:
  • Crestor
Active Comparator: randomised to rosuvastatin (10mg/d)
Drug: rosuvastatin
different dose of rosuvastatin treatment
Other Names:
  • Crestor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline; 4 and 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline; 4 and 24 weeks
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
PCI-related MI will be assesed within 24 hours after the end of the coronary artery stenting procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiao-dong Zhuang

Collaborators

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

November 14, 2014

First Submitted That Met QC Criteria

November 21, 2014

First Posted (Estimate)

November 24, 2014

Study Record Updates

Last Update Posted (Estimate)

July 14, 2015

Last Update Submitted That Met QC Criteria

July 13, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RETAIN Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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