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

NCT02545231 | Completed Phase 4 DMC

• 1 other identifier: Pitavastatin
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerosis; Neointima; Angina

Outcome Measures

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

  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 Outcomes (1)

• Rates of major adverse cardiovascular events during 12 months follow-up

  12 months for clinical events

Study Arms (2)

Low dose 1mg pitavastatin

ACTIVE COMPARATOR

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

Drug: Pitavastatin 1mg; Drug: Placebo

High dose 4mg pitavastatin

ACTIVE COMPARATOR

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

Drug: Pitavastatin 4mg; Drug: Placebo

Interventions

Pitavastatin 1mg DRUG

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

Also known as: Livalo 1mg

Low dose 1mg pitavastatin

Pitavastatin 4mg DRUG

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

Also known as: Livalo 4mg

High dose 4mg pitavastatin

Placebo DRUG

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

High dose 4mg pitavastatin; Low dose 1mg pitavastatin

Eligibility Criteria

• Age: 30 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University Anam Hospital: lead

Study Sites (1)

Korea University Anam Hospital

Seoul, 136-705, South Korea

Location

Related Publications (2)

• 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.

  PMID: 31752850 DERIVED

• 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.

  PMID: 30047013 DERIVED

MeSH Terms

Conditions

Atherosclerosis; Neointima; Angina Pectoris

Interventions

pitavastatin

Condition Hierarchy (Ancestors)

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

Study Officials

• Do-Sun Lim, MD, PhD

  Korea University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 2, 2015
• First Posted: September 9, 2015
• Study Start: February 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: August 1, 2020
• Last Updated: November 10, 2020

Record last verified: 2020-11

Locations

KR (1)