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Completed

NCT Number: NCT02545231

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

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.

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Key information

Conditions

Atherosclerosis Angina Angina Pectoris Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neointima Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

30 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Korea University Anam Hospital

Seoul, 136-705, South Korea

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pitavastatin 1mg

Drug

To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia

Other names: Livalo 1mg

Pitavastatin 4mg

Drug

To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia

Other names: Livalo 4mg

Placebo

Drug

To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia

Primary outcomes

  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

    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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Korea University Anam Hospital

Other

Registry information

Official study 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

Acronym: ELEVATE

Important dates

Study start
2013
Primary completion
2018
Study completion
2020
First posted
Sep 9, 2015
Registry last updated
Nov 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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