Telomere ShorteningPhase 4NCT02299245
Rosuvastatin Effect on Telomere-telomerase System in ACS
A Phase 4 study testing rosuvastatin in people with Telomere Shortening and Telomere Length, Mean Leukocyte, run by Xiao-dong Zhuang.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Telomere Shortening, Telomere Length, Mean Leukocyte, 22q Telomere Deletion Syndrome
- What is being tested?
- rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Nov 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient < 18 or > 80 years
- Renal dysfunction
- Hyperlipidemia
- Active myositis
- All forms of liver disease
- Pregnancy
- Breastfeeding
- Patients being treated with other type statin
About this study
Official title: Different Doses Rosuvastatin Effect on Telomere-telomerase System in Acute Coronary Syndrome Patients After Percutaneous Coronary INtervention: RETAIN Study
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.
Read the detailed 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.
- Being tested
- rosuvastatin
- Keywords
- telomere, telomerase, statin, percutaneous coronary intervention, acute coronary syndrome
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rosuvastatinDrug
Also called Crestor
different dose of rosuvastatin treatment
| Study group | Role | What they receive |
|---|---|---|
| randomised to rosuvastatin (20mg/d) | Experimental | randomised to rosuvastatin (20mg/d) Receives: Drug: rosuvastatin |
| randomised to rosuvastatin (10mg/d) | Active comparator | randomised to rosuvastatin (10mg/d) Receives: Drug: rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline; 4 and 24 weeks
Secondary outcomes (2)
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
Measured: baseline; 4 and 24 weeks
PCI-related myocardial infarction (MI)
PCI related myocardial infarction is defined by the third Universal definition of myocardial infarction
Measured: PCI-related MI will be assesed within 24 hours after the end of the coronary artery stenting procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionJul 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Telomere ShorteningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiao-dong Zhuang
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-sen University
- Responsible party
- Sponsor-investigator, Xiao-dong Zhuang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299245
- Sponsor's protocol ID
- RETAIN Study
- Status last verified
- Jul 2015
- First submitted
- 14 Nov 2014
- Last updated
- 14 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Doses Rosuvastatin Effect on Telomere-telomerase System in Acute Coronary Syndrome Patients After Percutaneous Coronary INtervention: RETAIN Study
- ClinicalTrials.gov ID
- NCT02299245
- Acronym / sponsor ID
- RETAIN Study
- Keywords
- telomere, telomerase, statin, percutaneous coronary intervention, acute coronary syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Xiao-dong ZhuangUniversity, hospital or other
- Collaborators
- Sun Yat-sen University
- Study start
- Oct 2014
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| randomised to rosuvastatin (20mg/d) | Experimental | Drug: rosuvastatinrandomised to rosuvastatin (20mg/d) |
| randomised to rosuvastatin (10mg/d) | Active comparator | Drug: rosuvastatinrandomised to rosuvastatin (10mg/d) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Patient < 18 or > 80 years
- Renal dysfunction
- Hyperlipidemia
- Active myositis
- All forms of liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rosuvastatinAlso: Crestordifferent dose of rosuvastatin treatment | Drug | randomised to rosuvastatin (10mg/d), randomised to rosuvastatin (20mg/d) |
Primary outcome
Change from baseline in telomere length after different dose statin treatment
Time frame: baseline; 4 and 24 weeks
telomere length of circulating leukocyte will be measured by Southern blot test before and after treatment
2 secondary outcomes
Change from baseline in telomerase activity after different dose statin treatment
Time frame: baseline; 4 and 24 weeks
PCI-related myocardial infarction (MI)
Time frame: PCI-related MI will be assesed within 24 hours after the end of the coronary artery stenting procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2015.
Related trials for Telomere Shortening
Not yet recruiting
TA-65 and Aging Associated Microvascular Dysfunction
Telomere Shortening, Aging
Active, not recruiting
Obesity and Aging: Impacts of Nutritional Counseling and Physical Exercise on Telomeres and Senescence Parameters
Aging, Obesity
Active, not recruitingPhase 1
Study to Evaluate of EXG34217 in Patients With Telomere Biology Disorders With Bone Marrow Failure
Telomere Shortening, Bone Marrow Failure
Enrolling by invitationObservational study
Telomeres and T-cell Receptor Excision Circles (TRECs) From Peripheral Blood in Normal Subjects Over Time
Telomere Length in Healthy Controls
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing rosuvastatin in people with Telomere Shortening and Telomere Length, Mean Leukocyte, run by Xiao-dong Zhuang.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in telomere length after different dose statin treatment (time frame: baseline; 4 and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2015.