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

November 8, 2020 updated by: Soon Jun Hong, Korea University Anam Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months for OCT and NIRS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of major adverse cardiovascular events during 12 months follow-up
Time Frame: 12 months for clinical events
Major adverse cardiovascular events include all-cause death, cardiovascular death, myocardial infarction, stroke, target vessel revascularization
12 months for clinical events

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University Anam Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

August 1, 2020

Study Registration Dates

First Submitted

September 2, 2015

First Submitted That Met QC Criteria

September 8, 2015

First Posted (Estimate)

September 9, 2015

Study Record Updates

Last Update Posted (Actual)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 8, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pitavastatin

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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