Effect of Low-dose vs. High-dose Pitavastatin on In-stent Restenosis
NCT ID: NCT02545231
Last Updated: 2020-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
1000 participants
INTERVENTIONAL
2013-02-28
2020-08-31
Brief Summary
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Low dose 1mg pitavastatin
pitavastatin 1mg which is considered low dose statin will be administered for 36 months
Pitavastatin 1mg
To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia
Placebo
To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia
High dose 4mg pitavastatin
pitavastatin 4mg which is considered high dose statin will be administered for 36 months
Pitavastatin 4mg
To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia
Placebo
To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia
Interventions
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Pitavastatin 1mg
To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia
Pitavastatin 4mg
To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia
Placebo
To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients between the age of 30 to 79
3. Non-ST elevation Acute coronary syndrome with successful everolimus eluting stent implantation (with TIMI flow grade 3 after the procedure)
Exclusion Criteria
2. Unable to perform OCT and NIRS
3. Serum creatinine \> 2.0 mg/dL.
4. Steroid or hormone replacement therapy
5. Hemoglobin A1c \>9%
6. Type 1 diabetes
7. Decreased serum platelet level (\< 100,000/uL)
8. Need for chronic oral anticoagulant therapy or chronic low-molecular-weight heparin
9. Life expectancy less than a year
10. Renal failure requiring dialysis or anticipated need for dialysis during the course of the study
11. Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study
12. Involvement in the planning and/or conduct of the study
13. Left ventricular ejection fraction \< 40%
14. Hepatic dysfunction (aspartate aminotransferase or alanine aminotransferase \> twice the upper limit)
15. Gastrointestinal disorder such as Crohn's disease
16. Alcohol abuse
17. Known pregnancy, breast-feeding, or intend to become pregnant during the study period
30 Years
79 Years
ALL
No
Sponsors
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Korea University Anam Hospital
OTHER
Responsible Party
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Soon Jun Hong
Professor
Principal Investigators
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Do-Sun Lim, MD, PhD
Role: STUDY_CHAIR
Korea University Hospital
Locations
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Korea University Anam Hospital
Seoul, , South Korea
Countries
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References
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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.
Lim 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.
Other Identifiers
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Pitavastatin
Identifier Type: -
Identifier Source: org_study_id