Rosuvastatin Effect on Telomere-telomerase System in ACS

NCT02299245 | Unknown Phase 4

• 1 other identifier: RETAIN Study
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Keywords

telomere; telomerase; statin; percutaneous coronary intervention; acute coronary syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Change from baseline in telomerase activity after different dose statin treatment

  baseline; 4 and 24 weeks

• PCI-related myocardial infarction (MI)

  PCI-related MI will be assesed within 24 hours after the end of the coronary artery stenting procedure

Study Arms (2)

randomised to rosuvastatin (20mg/d)

EXPERIMENTAL

randomised to rosuvastatin (20mg/d)

Drug: rosuvastatin

randomised to rosuvastatin (10mg/d)

ACTIVE COMPARATOR

randomised to rosuvastatin (10mg/d)

Drug: rosuvastatin

Interventions

rosuvastatin DRUG

different dose of rosuvastatin treatment

Also known as: Crestor

randomised to rosuvastatin (10mg/d); randomised to rosuvastatin (20mg/d)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient \< 18 or \> 80 years
• Renal dysfunction
• Hyperlipidemia
• Active myositis
• All forms of liver disease
• Pregnancy
• Breastfeeding
• Patients being treated with other type statin

Sponsors & Collaborators

• Xiao-dong Zhuang: lead
• Sun Yat-sen University: collaborator

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: director of the department of cardiology

Study Record Dates

• First Submitted: November 14, 2014
• First Posted: November 24, 2014
• Study Start: October 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: November 1, 2016
• Last Updated: July 14, 2015

Record last verified: 2015-07