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NCT02545231 | COMPLETED | Atherosclerosis

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

Korea University Anam Hospital

Information provided by (Responsible Party):

Soon Jun Hong

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

Atherosclerosis

Neointima

Angina

Intervention/treatment

Pitavastatin 1mg

Pitavastatin 4mg

Placebo

Phase

PHASE4

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 Type : INTERVENTIONAL
Estimated Enrollment : 1000 participants
Masking : DOUBLE
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
Actual Study Start Date : 2013-02
Estimated Primary Completion Date : 2018-12
Estimated Study Completion Date : 2020-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 30 Years to 79 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Effect of Low-dose vs. High-dose Pitavastatin on In-stent Restenosis

Location Details

NCT02545231

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Locations

Not yet recruiting

Korea, Republic of,

Korea University Anam Hospital

Seoul, Korea, Republic of, 136-705