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

Phase 4

Completed

• Conditions: Angina; Atherosclerosis; Neointima
• Interventions: Drug: Pitavastatin 1mg; Drug: Pitavastatin 4mg; Drug: Placebo

• Registration Number: NCT02545231
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-02
• Study First Submitted: 2015-09-02
• Study First Submitted QC: 2015-09-08
• Study First Posted: 2015-09-09
• Primary Completion: 2018-12
• Study Completion: 2020-08
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-08
• Last Update Posted: 2020-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose 1mg pitavastatin	Pitavastatin 1mg	pitavastatin 1mg which is considered low dose statin will be administered for 36 months
High dose 4mg pitavastatin	Pitavastatin 4mg	pitavastatin 4mg which is considered high dose statin will be administered for 36 months
High dose 4mg pitavastatin	Placebo	pitavastatin 4mg which is considered high dose statin will be administered for 36 months
Low dose 1mg pitavastatin	Placebo	pitavastatin 1mg which is considered low dose statin will be administered for 36 months

Primary Outcome Measures

Name	Time	Method
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	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

Name	Time	Method
Rates of major adverse cardiovascular events during 12 months follow-up	12 months for clinical events	Major adverse cardiovascular events include all-cause death, cardiovascular death, myocardial infarction, stroke, target vessel revascularization

Trial Locations

Locations (1)

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of