AtherosclerosisPhase 4ELEVATENCT02545231
Effect of Low-dose vs. High-dose Pitavastatin on In-stent Restenosis
A Phase 4 study testing Pitavastatin 1mg and Pitavastatin 4mg in people with Atherosclerosis and Neointima, run by Korea University Anam Hospital at 1 site in South Korea.
Trial summary
To compare low dose (1mg) pitavastatin and high dose (4mg) pitavastatin on neointimal hyperplasia and atherosclerosis progression by using optical coherence tomography (OCT) and near-infrared spectroscopy (NIRS) at 12 months follow-up and on clinical adverse cardiovascular events during 3-year follow-up. Read more about this study
- Who is it for?
- Ages 30 to 79 years
- Conditions the study is for
- Atherosclerosis, Neointima, Angina
- What is being tested?
- Pitavastatin 1mg and Pitavastatin 4mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2013to Aug 2020
- 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 30 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent prior to any study specific procedures
- Patients between the age of 30 to 79
- Non-ST elevation Acute coronary syndrome with successful everolimus eluting stent implantation (with TIMI flow grade 3 after the procedure)
Who cannot join
- Hypersensitivity to pitavastatin
- Unable to perform OCT and NIRS
- Serum creatinine > 2.0 mg/dL.
- Steroid or hormone replacement therapy
- Hemoglobin A1c >9%
- Type 1 diabetes
Show all 17Show fewer
- Decreased serum platelet level (< 100,000/uL)
- Need for chronic oral anticoagulant therapy or chronic low-molecular-weight heparin
- Life expectancy less than a year
- Renal failure requiring dialysis or anticipated need for dialysis during the course of the study
- Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study
- Involvement in the planning and/or conduct of the study
- Left ventricular ejection fraction < 40%
- Hepatic dysfunction (aspartate aminotransferase or alanine aminotransferase > twice the upper limit)
- Gastrointestinal disorder such as Crohn's disease
- Alcohol abuse
- Known pregnancy, breast-feeding, or intend to become pregnant during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Low-dose vs. High-dose Pitavastatin on In-stent Restenosis, Endothelial Function, Circulating microRNAs, and Cardiovascular Events in Patients With Coronary Artery Disease Requiring Stent Implantation: OCT and NIRS Comparison
To compare low dose (1mg) pitavastatin and high dose (4mg) pitavastatin on neointimal hyperplasia and atherosclerosis progression by using optical coherence tomography (OCT) and near-infrared spectroscopy (NIRS) at 12 months follow-up and on clinical adverse cardiovascular events during 3-year follow-up.
Read the detailed description
- Patients with non-ST elevation ACS will be randomized into pitavastatin 1mg or 4mg after everolimus-eluting stent implantation with OCT and NIRS study.
- 12 months follow-up coronary angiography with OCT and NIRS will be performed to compare neointimal hyperplasia and atherosclerosis progression.
- 36 months clinical follow-up for major adverse cardiovascular events (cardiac death, all-cause death, myocardial infarction, stroke, target lesion revascularization) will be compared.
- Safety issues such as bleeding rates, abnormal liver function will be compared
- Conditions
- Atherosclerosis, Neointima, Angina
- Being tested
- Pitavastatin 1mg, Pitavastatin 4mg, Placebo
- Medical subject headings
- Atherosclerosis, Neointima, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pitavastatin 1mgDrug
Also called Livalo 1mg
To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia
Pitavastatin 4mgDrug
Also called Livalo 4mg
To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia
PlaceboDrug
To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia
| Study group | Role | What they receive |
|---|---|---|
| Low dose 1mg pitavastatin | Active comparator | pitavastatin 1mg which is considered low dose statin will be administered for 36 months Receives: Drug: Pitavastatin 1mg; Drug: Placebo |
| High dose 4mg pitavastatin | Active comparator | pitavastatin 4mg which is considered high dose statin will be administered for 36 months Receives: Drug: Pitavastatin 4mg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neointimal volume with OCT (mm3 per 1mm) and lipid volume with NIRS (the maximal lipid core burden index (LCBI) in 4 mm segment during 12 months of treatment
OCT will measure neointimal volume in every mm interval and will be averaged by dividing the total neointimal volume with the number of the segment analyzed. LCBI is the lipid volume index which is calculated automatically by the device, and LCBI > 400 is considered high lipid volume.
Measured: 12 months for OCT and NIRS
Secondary outcomes (1)
Rates of major adverse cardiovascular events during 12 months follow-up
Major adverse cardiovascular events include all-cause death, cardiovascular death, myocardial infarction, stroke, target vessel revascularization
Measured: 12 months for clinical events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startFeb 2013
- Primary completionDec 2018
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soon Jun Hong, Korea University Anam Hospital
- Investigators
- Do-Sun Lim, MD, PhD, Study chair, Korea University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545231
- Sponsor's protocol ID
- Pitavastatin
- Acronym
- ELEVATE
- Status last verified
- Nov 2020
- First submitted
- 2 Sep 2015
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jeong HS, Hong SJ, Son S, An H, Kook H, Joo HJ, Park JH, Yu CW, Lim DS. Incidence of new-onset diabetes with 1 mg versus 4 mg pitavastatin in patients at high risk of developing diabetes during a 3-year follow-up. Cardiovasc Diabetol. 2019 Nov 21;18(1):162. doi: 10.1186/s12933-019-0969-z.
PubMed 31752850Lim JW, Jeong HS, Hong SJ, Kim HJ, Kim YC, Kang BG, Jeon SM, Cho JY, Lee SH, Joo HJ, Park JH, Yu CW. Effects of lowest-dose vs. highest-dose pitavastatin on coronary neointimal hyperplasia at 12-month follow-up in type 2 diabetic patients with non-ST elevation acute coronary syndrome: an optical coherence tomography analysis. Heart Vessels. 2019 Jan;34(1):62-73. doi: 10.1007/s00380-018-1227-0. Epub 2018 Jul 25.
PubMed 30047013
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-dose vs. High-dose Pitavastatin on In-stent Restenosis, Endothelial Function, Circulating microRNAs, and Cardiovascular Events in Patients With Coronary Artery Disease Requiring Stent Implantation: OCT and NIRS Comparison
- ClinicalTrials.gov ID
- NCT02545231
- Acronym / sponsor ID
- ELEVATE / Pitavastatin
- Conditions
- Atherosclerosis, Neointima, Angina
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2018 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 9 Sep 2015 (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.
To compare low dose (1mg) pitavastatin and high dose (4mg) pitavastatin on neointimal hyperplasia and atherosclerosis progression by using optical coherence tomography (OCT) and near-infrared spectroscopy (NIRS) at 12 months follow-up and on clinical adverse cardiovascular events during 3-year follow-up.
Detailed description
- Patients with non-ST elevation ACS will be randomized into pitavastatin 1mg or 4mg after everolimus-eluting stent implantation with OCT and NIRS study.
- 12 months follow-up coronary angiography with OCT and NIRS will be performed to compare neointimal hyperplasia and atherosclerosis progression.
- 36 months clinical follow-up for major adverse cardiovascular events (cardiac death, all-cause death, myocardial infarction, stroke, target lesion revascularization) will be compared.
- Safety issues such as bleeding rates, abnormal liver function will be compared
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose 1mg pitavastatin | Active comparator | Drug: Pitavastatin 1mg, Drug: Placebopitavastatin 1mg which is considered low dose statin will be administered for 36 months |
| High dose 4mg pitavastatin | Active comparator | Drug: Pitavastatin 4mg, Drug: Placebopitavastatin 4mg which is considered high dose statin will be administered for 36 months |
Who may qualify
- Ages
- 30 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Provision of informed consent prior to any study specific procedures
- Patients between the age of 30 to 79
- Non-ST elevation Acute coronary syndrome with successful everolimus eluting stent implantation (with TIMI flow grade 3 after the procedure)
Key exclusion criteria (17 listed)
- Hypersensitivity to pitavastatin
- Unable to perform OCT and NIRS
- Serum creatinine > 2.0 mg/dL.
- Steroid or hormone replacement therapy
- Hemoglobin A1c >9%
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 |
|---|---|---|
| Pitavastatin 1mgAlso: Livalo 1mgTo compare different doses of statins on atherosclerosis progression and neointimal hyperplasia | Drug | Low dose 1mg pitavastatin |
| Pitavastatin 4mgAlso: Livalo 4mgTo compare different doses of statins on atherosclerosis progression and neointimal hyperplasia | Drug | High dose 4mg pitavastatin |
| PlaceboTo compare different doses of statins on atherosclerosis progression and neointimal hyperplasia | Drug | High dose 4mg pitavastatin, Low dose 1mg pitavastatin |
Primary outcome
Neointimal volume with OCT (mm3 per 1mm) and lipid volume with NIRS (the maximal lipid core burden index (LCBI) in 4 mm segment during 12 months of treatment
Time frame: 12 months for OCT and NIRS
OCT will measure neointimal volume in every mm interval and will be averaged by dividing the total neointimal volume with the number of the segment analyzed. LCBI is the lipid volume index which is calculated automatically by the device, and LCBI > 400 is considered high lipid volume.
1 secondary outcome
Rates of major adverse cardiovascular events during 12 months follow-up
Time frame: 12 months for clinical events
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 10 Nov 2020.
- Derived from this study: PubMed 31752850Jeong HS, Hong SJ, Son S, An H, Kook H, Joo HJ, Park JH, Yu CW, Lim DS. Incidence of new-onset diabetes with 1 mg versus 4 mg pitavastatin in patients at high risk of developing diabetes during a 3-year follow-up. Cardiovasc Diabetol. 2019 Nov 21;18(1):162. doi: 10.1186/s12933-019-0969-z.
- Derived from this study: PubMed 30047013Lim JW, Jeong HS, Hong SJ, Kim HJ, Kim YC, Kang BG, Jeon SM, Cho JY, Lee SH, Joo HJ, Park JH, Yu CW. Effects of lowest-dose vs. highest-dose pitavastatin on coronary neointimal hyperplasia at 12-month follow-up in type 2 diabetic patients with non-ST elevation acute coronary syndrome: an optical coherence tomography analysis. Heart Vessels. 2019 Jan;34(1):62-73. doi: 10.1007/s00380-018-1227-0. Epub 2018 Jul 25.
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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.
Do-Sun Lim, MD, PhD study chair
Korea University 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 Pitavastatin 1mg and Pitavastatin 4mg in people with Atherosclerosis and Neointima, run by Korea University Anam Hospital 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 3 inclusion and 17 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 10 Nov 2020. 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?
Neointimal volume with OCT (mm3 per 1mm) and lipid volume with NIRS (the maximal lipid core burden index (LCBI) in 4 mm segment during 12 months of treatment (time frame: 12 months for OCT and NIRS). 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 NCT02545231, which also lists 2 linked publications.
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 10 Nov 2020.