Clinical trial NCT02299245: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Telomere Shortening
Telomere Length, Mean Leukocyte
22q Telomere Deletion Syndrome
Keywords: telomere
telomerase
statin
percutaneous coronary intervention
acute coronary syndrome
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
First posted: 2014-11-24
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline in telomere length after different dose statin treatment
timeFrame: baseline; 4 and 24 weeks
Secondary outcomes:
measure: Change from baseline in telomerase activity after different dose statin treatment
timeFrame: baseline; 4 and 24 weeks
measure: PCI-related myocardial infarction (MI)
timeFrame: PCI-related MI will be assesed within 24 hours after the end of the coronary artery stenting procedure
Other outcomes:
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