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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02299245
Other study ID # RETAIN Study
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received November 14, 2014
Last updated July 13, 2015
Start date October 2014
Est. completion date November 2016

Study information

Verified date July 2015
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority China: National Natural Science Foundation
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 400
Est. completion date November 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
rosuvastatin
different dose of rosuvastatin treatment

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Xiao-dong Zhuang Sun Yat-sen University

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary 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 No
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