Rosuvastatin Effect on Telomere-telomerase System in ACS

Xiao-dong Zhuang

Status and phase: Unknown; Phase 4

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

Treatments: Drug: rosuvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02299245

RETAIN Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

randomised to rosuvastatin (20mg/d)

Experimental group

Description:

randomised to rosuvastatin (20mg/d)

Treatment:

Drug: rosuvastatin

randomised to rosuvastatin (10mg/d)

Active Comparator group

Description:

randomised to rosuvastatin (10mg/d)

Treatment:

Drug: rosuvastatin