Rosuvastatin Effect on Telomere-telomerase System in ACS

NCT ID: NCT02299245

Last Updated: 2015-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-11-30

Brief Summary

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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

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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.

Conditions

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Telomere Shortening Telomere Length, Mean Leukocyte 22q Telomere Deletion Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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randomised to rosuvastatin (20mg/d)

randomised to rosuvastatin (20mg/d)

Group Type EXPERIMENTAL

rosuvastatin

Intervention Type DRUG

different dose of rosuvastatin treatment

randomised to rosuvastatin (10mg/d)

randomised to rosuvastatin (10mg/d)

Group Type ACTIVE_COMPARATOR

rosuvastatin

Intervention Type DRUG

different dose of rosuvastatin treatment

Interventions

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rosuvastatin

different dose of rosuvastatin treatment

Intervention Type DRUG

Other Intervention Names

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Crestor

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role collaborator

Xiao-dong Zhuang

OTHER

Sponsor Role lead

Responsible Party

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Xiao-dong Zhuang

director of the department of cardiology

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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RETAIN Study

Identifier Type: -

Identifier Source: org_study_id

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