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ELEVATE: Effect of Low-dose vs. High-dose Pitavastatin on In-stent Restenosis

Sponsor
Korea University Anam Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02545231
Collaborator
(none)
1,000
Enrollment
1
Location
2
Arms
90
Duration (Months)
11.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Pitavastatin 1mg
  • Drug: Pitavastatin 4mg
  • Drug: Placebo
 Phase 4

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

Study Type:
Interventional
Actual Enrollment :
1000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Study Start Date :
Feb 1, 2013
Actual Primary Completion Date :
Dec 1, 2018
Actual Study Completion Date :
Aug 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Low dose 1mg pitavastatin

pitavastatin 1mg which is considered low dose statin will be administered for 36 months

Drug: Pitavastatin 1mg
To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia
Other Names:
  • Livalo 1mg

    • Drug: Placebo
    To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia
    Active Comparator: High dose 4mg pitavastatin

    pitavastatin 4mg which is considered high dose statin will be administered for 36 months

    Drug: Pitavastatin 4mg
    To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia
    Other Names:
  • Livalo 4mg

    • Drug: Placebo
    To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia

    Outcome Measures

    Primary Outcome Measures

    1. 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 [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.

    Secondary Outcome Measures

    1. Rates of major adverse cardiovascular events during 12 months follow-up [12 months for clinical events]

      Major adverse cardiovascular events include all-cause death, cardiovascular death, myocardial infarction, stroke, target vessel revascularization

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 79 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Provision of informed consent prior to any study specific procedures

    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:

    1. Hypersensitivity to pitavastatin

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Korea University Anam Hospital Seoul Korea, Republic of 136-705

    Sponsors and Collaborators

    • Korea University Anam Hospital

    Investigators

    • Study Chair: Do-Sun Lim, MD, PhD, Korea University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Soon Jun Hong, Professor, Korea University Anam Hospital
    ClinicalTrials.gov Identifier:
    NCT02545231
    Other Study ID Numbers:
    • Pitavastatin
    First Posted:
    Sep 9, 2015
    Last Update Posted:
    Nov 10, 2020
    Last Verified:
    Nov 1, 2020
    Additional relevant MeSH terms:
    Atherosclerosis
    Neointima
    Pitavastatin

    Study Results

    No Results Posted as of Nov 10, 2020