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

Atherosclerosis Clinical Trial

— ELEVATE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02545231
• Other study ID #: Pitavastatin
• Status: Completed
• Phase: Phase 4
• Start date: February 2013
• Est. completion date: August 2020

Study information

• Verified date: November 2020
• Source: Korea University Anam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: August 2020
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Angina
• Atherosclerosis
• Neointima

Intervention

Drug:
• Pitavastatin 1mg
To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia
• Pitavastatin 4mg
To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia
• Placebo
To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Anam Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rates of major adverse cardiovascular events during 12 months follow-up	Major adverse cardiovascular events include all-cause death, cardiovascular death, myocardial infarction, stroke, target vessel revascularization	12 months for clinical events