Drug-eluting Stent (DES)Phase 4statinNCT01557075
Aspirin Mono Therapy 12-months After Drug-eluting Stents Implantation
A Phase 4 study testing Atorvastatin (High dose statin treatment) and Pravastatin (High dose statin treatment) in people with Drug-eluting Stent (DES), run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether high dose statin therapy in patients with aspirin mono antiplatelet therapy who had received drug-eluting stent (DES) previously and were free of the adverse cardiac events during the first 12 months could be superior over pravastatin therapy in the prevention of late… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Drug-eluting Stent (DES)
- What is being tested?
- Atorvastatin (High dose statin treatment) and Pravastatin (High dose statin treatment)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2010to Aug 2015
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who had previously received DES at least 12 months(±2month) ago
- Patients who were free of death, MI, stroke, repeat revascularization, or ST within first 12 months after DES implantation
- Patients with mono antiplatelet therapy with only aspirin after
- Age 20 years of older
- Patients with signed informed consent
Who cannot join
- History of DES or BMS implantation within 10 months
- Patients who required the continuing dual antiplatelet therapy or additional other types of antithrombotics or antiplatelets such as cilostazol or ticlopidine, etc besides aspirin after DES implantation
- Patients who could not be prescribed aspirin or statins due to contraindication or severe side effects
- Pregnant women or women with potential childbearing
- Life expectancy ≤ 2 year
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hong Myeong-Ki
Seoul
Myeong-Ki Hong, MD.PhD, +82 2 2228 8458, mkhong61@yuhs.ac
Byeong-Keuk Kim, MD.PhD, +82 2 2228 8465, kimbk@yuhs.ac
About this study
Official title: Effects of High-dose Statin Treatments on Patients With Aspirin Mono Antiplatelet Therapy 12-months After Drug-eluting Stents Implantation: a Randomized Controlled Study
The purpose of this study is to determine whether high dose statin therapy in patients with aspirin mono antiplatelet therapy who had received drug-eluting stent (DES) previously and were free of the adverse cardiac events during the first 12 months could be superior over pravastatin therapy in the prevention of late adverse cardiac and cerebrovascular events during the additional 12 months.
Study Design.
Read the detailed description
Objective: To determine whether high dose statin therapy in patients with aspirin mono antiplatelet therapy who had received drug-eluting stent (DES) previously and were free of the adverse cardiac events during the first 12 months could be superior over pravastatin therapy in the prevention of late adverse cardiac and cerebrovascular events during the additional 12 months.
Study Design
- Prospective, randomized, multi-center study of each 1000 subjects enrolled.
- Eligible subjects will be randomized 1:1 to a) atorvastatin 40 mg (n=1000) vs. b) pravastatin 20 mg/day (n=1000). All subjects will be followed for 1 year after randomization. Additional long-term follow-up (2- or 3-year) will be preceded in the next plan after 1-year study period.
- Subjects with coronary artery diseases who meet all inclusion and exclusion criteria will be included Clinical and laboratory follow-up should be performed.
- Conditions
- Drug-eluting Stent (DES)
- Being tested
- Atorvastatin (High dose statin treatment), Pravastatin (High dose statin treatment)
- Keywords
- High dose statin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin (High dose statin treatment)Drug
Also called DES-statin
Patients will be randomly assigned to the type of statins. Randomization of statin therapy will be done 1:1 to one of two different statins on the web-based program
- Atorvastatin 40 mg daily for 12 months after randomization
Pravastatin (High dose statin treatment)Drug
Patients will be randomly assigned to the type of statins. Randomization of statin therapy will be done 1:1 to one of two different statins on the web-based program
Pravastatin 20mg daily for 12 months after randomization
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin group | Active comparator | Atorvastatin 40 mg daily for 12 months after randomization Receives: Drug: Atorvastatin (High dose statin treatment) |
| Pravastatin group | Active comparator | Pravastatin 20mg daily for 12 months after randomization Receives: Drug: Pravastatin (High dose statin treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the composite of death from any cause
Occurrence of the composite of death from any cause, MI, target vessel revascularization (TVR, either by PCI or CABG), non-TVR, stent thrombosis (ST), peripheral artery intervention, deterioration of renal function, stroke or admission for significant clinical cardiac events for 12 months following the randomization to the assigned statin therapy.
Measured: 12 months after randomization
Secondary outcomes (1)
cardiac or non-cardiac death
- Major determinant for the occurrence of major events(death,MI,TVR,ST)
- Comparisons of the occurrence of major events according to the attainment of recommended LDL-C goal on current lipid guideline
- Association between laboratory test and clinical outcomes;
- Sub-study according to the subsets of disease
- Association between parameters at index procedure and clinical outcomes
Measured: 12month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2012 (estimated)
- Study startJul 2010
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug-eluting Stent (DES)Studies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myeong-Ki Hong, Yonsei University
- Investigators
- Myeong-Ki Hong, MD.PhD., Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01557075
- Sponsor's protocol ID
- 4-2010-0298
- Acronym
- statin
- Status last verified
- Mar 2012
- First submitted
- 12 Mar 2012
- Last updated
- 19 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Im E, Cho YH, Suh Y, Cho DK, Her AY, Kim YH, Lee K, Kang WC, Yun KH, Yoo SY, Cheong SS, Shin DH, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Hong MK. High-intensity Statin Treatments in Clinically Stable Patients on Aspirin Monotherapy 12 Months After Drug-eluting Stent Implantation: A Randomized Study. Rev Esp Cardiol (Engl Ed). 2018 Jun;71(6):423-431. doi: 10.1016/j.rec.2017.06.008. Epub 2017 Jul 14. English, Spanish.
PubMed 28716428
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-dose Statin Treatments on Patients With Aspirin Mono Antiplatelet Therapy 12-months After Drug-eluting Stents Implantation: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01557075
- Acronym / sponsor ID
- statin / 4-2010-0298
- Conditions
- Drug-eluting Stent (DES)
- Keywords
- High dose statin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 19 Mar 2012 (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.
The purpose of this study is to determine whether high dose statin therapy in patients with aspirin mono antiplatelet therapy who had received drug-eluting stent (DES) previously and were free of the adverse cardiac events during the first 12 months could be superior over pravastatin therapy in the prevention of late adverse cardiac and cerebrovascular events during the additional 12 months.
Study Design.
Detailed description
Objective: To determine whether high dose statin therapy in patients with aspirin mono antiplatelet therapy who had received drug-eluting stent (DES) previously and were free of the adverse cardiac events during the first 12 months could be superior over pravastatin therapy in the prevention of late adverse cardiac and cerebrovascular events during the additional 12 months.
Study Design
- Prospective, randomized, multi-center study of each 1000 subjects enrolled.
- Eligible subjects will be randomized 1:1 to a) atorvastatin 40 mg (n=1000) vs. b) pravastatin 20 mg/day (n=1000). All subjects will be followed for 1 year after randomization. Additional long-term follow-up (2- or 3-year) will be preceded in the next plan after 1-year study period.
- Subjects with coronary artery diseases who meet all inclusion and exclusion criteria will be included Clinical and laboratory follow-up should be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin group | Active comparator | Drug: Atorvastatin (High dose statin treatment)Atorvastatin 40 mg daily for 12 months after randomization |
| Pravastatin group | Active comparator | Drug: Pravastatin (High dose statin treatment)Pravastatin 20mg daily for 12 months after randomization |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who had previously received DES at least 12 months(±2month) ago
- Patients who were free of death, MI, stroke, repeat revascularization, or ST within first 12 months after DES implantation
- Patients with mono antiplatelet therapy with only aspirin after
- Age 20 years of older
- Patients with signed informed consent
Key exclusion criteria (5 listed)
- History of DES or BMS implantation within 10 months
- Patients who required the continuing dual antiplatelet therapy or additional other types of antithrombotics or antiplatelets such as cilostazol or ticlopidine, etc besides aspirin after DES implantation
- Patients who could not be prescribed aspirin or statins due to contraindication or severe side effects
- Pregnant women or women with potential childbearing
- Life expectancy ≤ 2 year
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 |
|---|---|---|
| Atorvastatin (High dose statin treatment)Also: DES-statinPatients will be randomly assigned to the type of statins. Randomization of statin therapy will be done 1:1 to one of two different statins on the web-based program * Atorvastatin 40 mg daily for 12 months after randomization | Drug | Atorvastatin group |
| Pravastatin (High dose statin treatment)Patients will be randomly assigned to the type of statins. Randomization of statin therapy will be done 1:1 to one of two different statins on the web-based program Pravastatin 20mg daily for 12 months after randomization | Drug | Pravastatin group |
Primary outcome
the composite of death from any cause
Time frame: 12 months after randomization
Occurrence of the composite of death from any cause, MI, target vessel revascularization (TVR, either by PCI or CABG), non-TVR, stent thrombosis (ST), peripheral artery intervention, deterioration of renal function, stroke or admission for significant clinical cardiac events for 12 months following the randomization to the assigned statin therapy.
1 secondary outcome
cardiac or non-cardiac death
Time frame: 12month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2012.
- Derived from this study: PubMed 28716428Im E, Cho YH, Suh Y, Cho DK, Her AY, Kim YH, Lee K, Kang WC, Yun KH, Yoo SY, Cheong SS, Shin DH, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Hong MK. High-intensity Statin Treatments in Clinically Stable Patients on Aspirin Monotherapy 12 Months After Drug-eluting Stent Implantation: A Randomized Study. Rev Esp Cardiol (Engl Ed). 2018 Jun;71(6):423-431. doi: 10.1016/j.rec.2017.06.008. Epub 2017 Jul 14. English, Spanish.
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Recruiting
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ICAD - Intracranial Atherosclerotic Disease, ICAS - Intracranial Atherosclerosis
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.
Myeong-Ki Hong, MD.PhD. principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atorvastatin (High dose statin treatment) and Pravastatin (High dose statin treatment) in people with Drug-eluting Stent (DES), run by Yonsei University at 1 site in South Korea.
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 5 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 19 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Myeong-Ki Hong, MD,PhD (+82 2 2228 8458, mkhong61@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the composite of death from any cause (time frame: 12 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01557075, which also lists 1 linked publication.
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 19 Mar 2012; AzTrials last refreshed its copy on 8 Nov 2026.