Acute Coronary SyndromePhase 4NCT01857843
Early Effects of Intensive Lipid Lowering Treatment With Ezetimibe/ Simvastatin (Vytorin®) Assessed by Virtual Histology-Intravascular Ultrasound (VH-IVUS) and Optical Coherence Tomography (OCT) on Plaque Characteristics in Patients With Acute Coronary Syndrome
A Phase 4 study testing Zotalolimus Eluting Stent, Everolimus eluting stent and Ezetimibe 10mg & Simvastatin 40mg in people with Acute Coronary Syndrome, run by Yonsei University at 1 site in South Korea.
Trial summary
Objective: To evaluate the early effects of intensive lipid lowering treatments with ezetimibe/simvastatin (Vytorin®) for each component of coronary plaques. Study Design Prospective, randomized, single-center study of each 80 subjects enrolled Subjects with acute coronary syndrome who meet all inclusion and exclusion… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Zotalolimus Eluting Stent, Everolimus eluting stent and Ezetimibe 10mg & Simvastatin 40mg
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2009to Jan 2014
- 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
- General inclusion criteria
- Acute coronary syndrome including unstable angina, acute non-ST elevation myocardial infarction and acute ST elevation myocardial infarction
- Age of 20 years or older
- Patients with signed informed consent
- Angiographic inclusion criteria
- De novo lesion without significant plaque (angiographic lumen diameter stenosis < 50%)
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- Reference vessel diameter ?> 3.0 mm by operator assessment
- Segment length of 10-20 mm
- Distance from the PCI site > 5.0mm (either proximal or distal)
- Available for serial high quality IVUS studies of the entire segment.
Who cannot join
- Failed PCI
- Recommended coronary artery bypass grafting (CABG)
- Cardiogenic Shock
- Administration of lipid lowering agents before enrollment
- Significant hepatic dysfunction (3 times normal reference values)
- Significant renal dysfunction (Serum creatinine > 2.0 mg/dl)
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- Significant leukopenia, thrombocytopenia, anemia, or known bleeding diathesis
- Pregnant women or women with potential childbearing
- Saphenous vein graft
Trial locations and contacts
1 site in 1 country.
About this study
Objective: To evaluate the early effects of intensive lipid lowering treatments with ezetimibe/simvastatin (Vytorin®) for each component of coronary plaques.
Study Design
- Prospective, randomized, single-center study of each 80 subjects enrolled
- Subjects with acute coronary syndrome who meet all inclusion and exclusion criteria will be enrolled.
- Eligible subjects will be randomized 1:1 to A) Ezetimibe/Simvastatin (n=80) vs. B) Pravastatin (n=80), and each group of patients will be randomized further in a ratio of 1:1 to a) ZES (n=40) vs. b) EES (n=40), according to the type of stent used.
- All subjects will undergo VH-IVUS at initial procedure.
- Follow-up VH-IVUS will be performed at 3 months after index procedure. OCT at initial procedure and 3-months will be performed in available cases.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Zotalolimus Eluting Stent, Everolimus eluting stent, Ezetimibe 10mg & Simvastatin 40mg, Pravastatin 20mg
- 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.
Zotalolimus Eluting StentDevice
Permuted block randomization into 4 groups according to the type of drug and stent will be carried out in a ratio of 1:1:1:1(i.e.,Vytorin-ZES, Vytorin-EES, mevalotin-ZES, or mevalotin-EES) for balanced randomization.
Patients with native coronary arteries who fulfill all enrollment criteria for OCT study will be randomized to receive either ZES (Endeavor®-Sprint or Resolute-integrity) or EES (Xience®) in a ratio of 1:1.
Everolimus eluting stentDevice
Permuted block randomization into 4 groups according to the type of drug and stent will be carried out in a ratio of 1:1:1:1(i.e.,Vytorin-ZES, Vytorin-EES, mevalotin-ZES, or mevalotin-EES) for balanced randomization.
Patients with native coronary arteries who fulfill all enrollment criteria for OCT study will be randomized to receive either ZES (Endeavor®-Sprint or resolute-integrity) or EES (Xience®) in a ratio of 1:1.
Ezetimibe 10mg & Simvastatin 40mgDrug
Permuted block randomization into 4 groups according to the type of drug and stent will be carried out in a ratio of 1:1:1:1(i.e.,Vytorin-ZES, Vytorin-EES, mevalotin-ZES, or mevalotin-EES) for balanced randomization.
Patients will be randomized in a ratio of 1:1 according to the two different types of lipid lowering treatment.
- Ezetimibe 10mg/Simvastatin 40mg (Vytorin®, MSD)
- Pravastatin 20mg (mevalotin®, BMS)
Pravastatin 20mgDrug
Permuted block randomization into 4 groups according to the type of drug and stent will be carried out in a ratio of 1:1:1:1(i.e.,Vytorin-ZES, Vytorin-EES, mevalotin-ZES, or mevalotin-EES) for balanced randomization.
Patients will be randomized in a ratio of 1:1 according to the two different types of lipid lowering treatment.
- Ezetimibe 10mg/Simvastatin 40mg (Vytorin®, MSD)
- Pravastatin 20mg (mevalotin®, BMS)
| Study group | Role | What they receive |
|---|---|---|
| ZES group | Experimental | Not described Receives: Device: Zotalolimus Eluting Stent |
| EES group | Active comparator | Not described Receives: Device: Everolimus eluting stent |
| Vytorin group | Experimental | Not described Receives: Drug: Ezetimibe 10mg & Simvastatin 40mg |
| Mevalotin group | Active comparator | Not described Receives: Drug: Pravastatin 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative change in fibrofatty component of plaque measured by VH-IVUS
Measured: baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study startNov 2009
- Primary completionNov 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01857843
- Sponsor's protocol ID
- 1-2009-0032
- Status last verified
- Feb 2014
- First submitted
- 15 May 2013
- Last updated
- 5 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Effects of Intensive Lipid Lowering Treatment With Ezetimibe/ Simvastatin (Vytorin®) Assessed by Virtual Histology-Intravascular Ultrasound (VH-IVUS) and Optical Coherence Tomography (OCT) on Plaque Characteristics in Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT01857843
- Acronym / sponsor ID
- 1-2009-0032
- Conditions
- Acute Coronary Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Nov 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 20 May 2013 (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.
Objective: To evaluate the early effects of intensive lipid lowering treatments with ezetimibe/simvastatin (Vytorin®) for each component of coronary plaques.
Study Design
- Prospective, randomized, single-center study of each 80 subjects enrolled
- Subjects with acute coronary syndrome who meet all inclusion and exclusion criteria will be enrolled.
- Eligible subjects will be randomized 1:1 to A) Ezetimibe/Simvastatin (n=80) vs. B) Pravastatin (n=80), and each group of patients will be randomized further in a ratio of 1:1 to a) ZES (n=40) vs. b) EES (n=40), according to the type of stent used.
- All subjects will undergo VH-IVUS at initial procedure.
- Follow-up VH-IVUS will be performed at 3 months after index procedure. OCT at initial procedure and 3-months will be performed in available cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ZES group | Experimental | Device: Zotalolimus Eluting Stent |
| EES group | Active comparator | Device: Everolimus eluting stent |
| Vytorin group | Experimental | Drug: Ezetimibe 10mg & Simvastatin 40mg |
| Mevalotin group | Active comparator | Drug: Pravastatin 20mg |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- General inclusion criteria
- Acute coronary syndrome including unstable angina, acute non-ST elevation myocardial infarction and acute ST elevation myocardial infarction
- Age of 20 years or older
- Patients with signed informed consent
- Angiographic inclusion criteria
Key exclusion criteria (9 listed)
- Failed PCI
- Recommended coronary artery bypass grafting (CABG)
- Cardiogenic Shock
- Administration of lipid lowering agents before enrollment
- Significant hepatic dysfunction (3 times normal reference values)
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 |
|---|---|---|
| Zotalolimus Eluting StentPermuted block randomization into 4 groups according to the type of drug and stent will be carried out in a ratio of 1:1:1:1(i.e.,Vytorin-ZES, Vytorin-EES, mevalotin-ZES, or mevalotin-EES) for balanced randomization. Patients with native coronary arteries who fulfill all enrollment criteria for OCT study will be randomized to receive either ZES (Endeavor®-Sprint or Resolute-integrity) or EES (Xience®) in a ratio of 1:1. | Device | ZES group |
| Everolimus eluting stentPermuted block randomization into 4 groups according to the type of drug and stent will be carried out in a ratio of 1:1:1:1(i.e.,Vytorin-ZES, Vytorin-EES, mevalotin-ZES, or mevalotin-EES) for balanced randomization. Patients with native coronary arteries who fulfill all enrollment criteria for OCT study will be randomized to receive either ZES (Endeavor®-Sprint or resolute-integrity) or EES (Xience®) in a ratio of 1:1. | Device | EES group |
| Ezetimibe 10mg & Simvastatin 40mgPermuted block randomization into 4 groups according to the type of drug and stent will be carried out in a ratio of 1:1:1:1(i.e.,Vytorin-ZES, Vytorin-EES, mevalotin-ZES, or mevalotin-EES) for balanced randomization. Patients will be randomized in a ratio of 1:1 according to the two different types of lipid lowering treatment. 1. Ezetimibe 10mg/Simvastatin 40mg (Vytorin®, MSD) 2. Pravastatin 20mg (mevalotin®, BMS) | Drug | Vytorin group |
| Pravastatin 20mgPermuted block randomization into 4 groups according to the type of drug and stent will be carried out in a ratio of 1:1:1:1(i.e.,Vytorin-ZES, Vytorin-EES, mevalotin-ZES, or mevalotin-EES) for balanced randomization. Patients will be randomized in a ratio of 1:1 according to the two different types of lipid lowering treatment. 1. Ezetimibe 10mg/Simvastatin 40mg (Vytorin®, MSD) 2. Pravastatin 20mg (mevalotin®, BMS) | Drug | Mevalotin group |
Primary outcome
Quantitative change in fibrofatty component of plaque measured by VH-IVUS
Time frame: baseline and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2014.
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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.
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 Zotalolimus Eluting Stent, Everolimus eluting stent and Ezetimibe 10mg & Simvastatin 40mg in people with Acute Coronary Syndrome, 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 10 inclusion and 9 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: finished, as of the sponsor's last update on 5 Feb 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quantitative change in fibrofatty component of plaque measured by VH-IVUS (time frame: baseline and 3 months). 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 5 Feb 2014.