A Post-Marketing Clinical Study of Livalo Tablets: Evaluation of Effects on Yellow Plaques in the Coronary Arteries of Patients with Hypercholesterolemia

Phase 4

• Conditions: Hypercholesterolemia Familial Hypercholesterolemia

• Registration Number: JPRN-UMIN000001107
• Lead Sponsor: KOWA company, ltd.

Brief Summary

Fixed dose pitavastatin treatment stabilized vulnerable coronary plaques as shown by the reduction of angioscopically-determined yellow grade, but it did not significantly reduce plaque volume measured by IVUS. These results suggest that the mechanisms underlying the stabilization and regression of atherosclerotic plaques by statin may differ from each other, but both nonetheless contribute to the reduction of cardiovascular events.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2007-07-01
• Study Start: 2008-04-03
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients currently receiving Livalo Tablets or having discontinued Livalo therapy before; 2) Patients absolutely or relatively contraindicated against Livalo Tablets; 3) Patients with hepatopathy or having ALT (GPT) or AST (GOT) level exceeding 2.5 times the upper limit of the criterion range; 4) Patients with compromised renal function (serum creatinine over 2.0 mg/dL); 5) Patients with a history of severe myopathy or CK (CPK) exceeding 2.5 times the upper limit of the criterion range; 6) Patients within 24 hours after onset of acute myocardial infarction; 7) Patients within 1 month after onset of cerebrovascular disease; 8) Patients with a history of malignant tumor or complicated by malignant tumors within 5 years before the start of treatment with the test drug; 9) Poorly controlled diabetic patients (HbA1C over 8.0%); 10) Patients receiving LDL apheresis; 11) Patients with the homozygote type of familial hypercholesterolemia; 12) Patients requiring treatment with the drugs whose concomitant use during this study is prohibited; - Cyclosporine preparations - Fibrates - Nicotinic acid preparations - HMG-CoA reductase inhibitors other than the test drug - Cholestyramine 13)Drug addicts 14) Patients participating in some other clinical trials at present or having participated in other clinical trials completed within 4 months before; 15) Individuals judged as inappropriate for this post-marketing clinical study by the investigator or sub-investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effects of the drug on changes in plaque color (assessed by angioscopy) and plaque volume and echo density (evaluated by intravascular ultrasonography)

Secondary Outcome Measures

Name	Time	Method
Effects of the drug on changes in plaque color (assessed by angioscopy) and plaque volume and echo density (evaluated by intravascular ultrasonography)