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

Primary Purpose

Atherosclerosis, Neointima, Angina

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pitavastatin 1mg
Pitavastatin 4mg
Placebo
Sponsored by
Korea University Anam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atherosclerosis

Eligibility Criteria

30 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Korea University Anam Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Low dose 1mg pitavastatin

High dose 4mg pitavastatin

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 2, 2015
Last Updated
November 8, 2020
Sponsor
Korea University Anam Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02545231
Brief Title
Effect of Low-dose vs. High-dose Pitavastatin on In-stent Restenosis
Acronym
ELEVATE
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 Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
August 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University Anam Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, Neointima, Angina

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low dose 1mg pitavastatin
Arm Type
Active Comparator
Arm Description
pitavastatin 1mg which is considered low dose statin will be administered for 36 months
Arm Title
High dose 4mg pitavastatin
Arm Type
Active Comparator
Arm Description
pitavastatin 4mg which is considered high dose statin will be administered for 36 months
Intervention Type
Drug
Intervention Name(s)
Pitavastatin 1mg
Other Intervention Name(s)
Livalo 1mg
Intervention Description
To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia
Intervention Type
Drug
Intervention Name(s)
Pitavastatin 4mg
Other Intervention Name(s)
Livalo 4mg
Intervention Description
To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
12 months for OCT and NIRS
Secondary Outcome Measure Information:
Title
Rates of major adverse cardiovascular events during 12 months follow-up
Description
Major adverse cardiovascular events include all-cause death, cardiovascular death, myocardial infarction, stroke, target vessel revascularization
Time Frame
12 months for clinical events

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Do-Sun Lim, MD, PhD
Organizational Affiliation
Korea University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
31752850
Citation
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.
Results Reference
derived
PubMed Identifier
30047013
Citation
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.
Results Reference
derived

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

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