Rosuvastatin Effect on Telomere-telomerase System in ACS

Telomere Shortening Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02299245
• Other study ID #: RETAIN Study
• 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

Related Conditions & MeSH terms

• 22q Telomere Deletion Syndrome
• Acute Coronary Syndrome
• Telomere Length, Mean Leukocyte
• Telomere Shortening

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