Overview

This trial is active, not recruiting.

Conditions telomere shortening, telomere length, mean leukocyte, 22q telomere deletion syndrome
Treatment rosuvastatin
Phase phase 4
Sponsor Xiao-dong Zhuang
Collaborator Sun Yat-sen University
Start date October 2014
End date July 2016
Trial size 400 participants
Trial identifier NCT02299245, RETAIN Study

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
randomised to rosuvastatin (20mg/d)
rosuvastatin Crestor
different dose of rosuvastatin treatment
(Active Comparator)
randomised to rosuvastatin (10mg/d)
rosuvastatin Crestor
different dose of rosuvastatin treatment

Primary Outcomes

Measure
Change from baseline in telomere length after different dose statin treatment
time frame: baseline; 4 and 24 weeks

Secondary Outcomes

Measure
Change from baseline in telomerase activity after different dose statin treatment
time frame: 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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Different Doses Rosuvastatin Effect on Telomere-telomerase System in Acute Coronary Syndrome Patients After Percutaneous Coronary INtervention: RETAIN Study
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Sun Yat-sen University.