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

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ClinicalTrials.gov Identifier: NCT02545231
Recruitment Status : Active, not recruiting
First Posted : September 9, 2015
Last Update Posted : August 21, 2017
Sponsor:
Information provided by (Responsible Party):
Soon Jun Hong, Korea University Anam Hospital

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
Atherosclerosis Neointima Angina 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

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Study Type : Interventional  (Clinical Trial)
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 : February 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

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 Name: 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 Name: Livalo 4mg

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




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 [ 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 Outcome Measures :
  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



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Ages Eligible for Study:   30 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02545231


Locations
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Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of, 136-705
Sponsors and Collaborators
Korea University Anam Hospital
Investigators
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Study Chair: Do-Sun Lim, MD, PhD Korea University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Soon Jun Hong, Professor, Korea University Anam Hospital
ClinicalTrials.gov Identifier: NCT02545231     History of Changes
Other Study ID Numbers: Pitavastatin
First Posted: September 9, 2015    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
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Atherosclerosis
Neointima
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Pitavastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents