Rosuvastatin Effect on Telomere-telomerase System in ACS

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Drug: rosuvastatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: randomised to rosuvastatin (20mg/d)<br>randomised to rosuvastatin (20mg/d) | Drug: rosuvastatin<br>* different dose of rosuvastatin treatment<br>* Other names: Crestor;|
| Active Comparator: randomised to rosuvastatin (10mg/d)<br>randomised to rosuvastatin (10mg/d) | Drug: rosuvastatin<br>* different dose of rosuvastatin treatment<br>* Other names: Crestor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telomere, telomerase, statin, percutaneous coronary intervention, acute coronary syndrome