A study to evaluate the efficacy of Rosuvastatin for patients with coronary plaque utilizing aggressive lipid lowering treatment

Not Applicable

• Conditions: Hypercholesterolemia

• Registration Number: JPRN-UMIN000001223
• Lead Sponsor: Kokura Memorial Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-07-01
• Study Completion: 2009-06-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

(1) Patients with familial hypercholesterolemia (2) Patients who took lipid lowering agent within 1 month before the study . (3) Patients who have undergone PCI/CABG in separate sites of coronary arteries. (4) Patients with history of unstable angina or ischemic syndrome. (5) Patients with concomitant cardiac failure and patients who have lowered cardiac functions. (6) Patients receiving insulin treatment (7) Patients receiving cyclosporine (8) Patients with hepatic function disorder (AST/ALT>=100 IU/L) (9) Patients with renal function disorder (serum creatinine >= 1.5 mg/dL) (10) Patients with serum CK >= 500 IU/L (11) Pregnant women and women suspected of being pregnant (12) Patients with hypothyroidism, hereditary muscular diseases (muscular dystrophy, etc.) or familial history of these diseases. Patients with history of drug-related muscular disorder (13) Patients with drug abuse or alcoholism (14) Patients with serious complication (15) Patients who are ineligible at physicians' discretion

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes from baseline in MLD and ALD at month 24

Secondary Outcome Measures

Name	Time	Method
Virtual histology intravascular ultrasound (VH-IVUS) and 64-row multi-detector-row computed tomography (64-row MDCT) will be conducted in patients who meet enablement requirement, and the relationship between changes in quantity of coronary plaque and quality of plaque will be evaluatedexploratory . Changes of intima media thickness (IMT) in carotid artery will be exploratory evaluated in patients who meet enablement requirement.