Effect of Pitavastatin on Coronary Fibrous-cap Thickness - Assessment by Fourier-Domain Optical Coherence Tomography (ESCORT)

Not Applicable

• Conditions: Patients with acute coronary syndrome with a history of having undergone successful percutaneous coronary intervention

• Registration Number: JPRN-UMIN000002678
• Lead Sponsor: Department of Cardiovascular Medicine, Wakayama Medical University

Brief Summary

Between baseline and 3-week follow-up, fibrous cap thickness increased in the early statin group (140um to 160um, p=0.017) but decreased in the late statin group (135um to 130um, p=0.020). The percentage of increase in fibrous cap thickness between baseline and 3-week follow-up was significantly greater in the early statin group compared with the late statin group (8.3% vs. -5.8%, p<0.001). Between baseline and 36-week follow-up, fibrous cap thickness increased comparably in the two groups.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-11-01
• Study Completion: 2014-09-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

1) Target PCI lesion is graft stenosis or in-stent restenosis 2) Patients who had undergone previous PCI for the lesion under evaluation. 3) Patients who have plaque in a non-culprit site on the PCI vessel that might call for PCI during the treatment period (non-culprit lesion is unrestricted) 4) Patients already receiving lipid lowering agents (HMG-CoA reductase inhibitors [statins], fibrates, probucol, nicotinic acid, anion exchange resins, or ezetimib) 5) Patients with familial hypercholesterolemia 6) Patients with cardiogenic shock 7) Patients on cyclosporine therapy 8) Patients with a history of hypersensitivity to any of the components of the product 9) Patients with liver dysfunction (ALT[GPT] >= 100IU), biliary obstruction and/or defective hepatic metabolism: acute hepatitis, acute exacerbation of chronic hepatitis, liver cirrhosis, hepatic carcinoma and/or icterus 10) Pregnant and possibly pregnant women, lactating women 11) Patients with renal dysfunction (serum creatinine >=2.0 mg/dL) or on maintenance dialysis 12) Patients who are judged by the principal or other investigator to be ineligible for enrollment in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent change in coronary fibrous-cap thickness

Secondary Outcome Measures

Name	Time	Method
1) Change in coronary fibrous-cap thickness 2) Absolute and percent change of the lipid core size 3) Absolute and percent changes of the serum LDL-C, TC, TG and HDL-C 4) Absolute and percent changes of the serum hs-CRP, MMP-9 and oxLDL 5) Correlation between percent changes of the serum lipid parameters and absolute/percent change of the coronary fibrous-cap thickness 6) Correlation between percent changes of the serum hs-CRP, MMP-9 and oxLDL and absolute/percent change of the coronary fibrous-cap thickness 7) Incidence of major adverse cardiovascular events (MACE; defined as cardiac death, Q-wave or non-Q-wave MI, PCI, or coronary artery bypass grafting) 8) All-cause mortality 9) Rate of adverse reactions 10) Changes of the laboratory test results