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

• Status: Completed
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Korea University Anam Hospital
• Treatments: Pitavastatin

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