Justification for Atherosclerosis Regression Treatment

UMIN ID: UMIN000001174

Registered date:06/06/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Hypercholesterolemia
• Date of first enrollment: 2008/06/01
• Target sample size: 400
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

5 mg Rosuvastatin will be orally administered once daily for two years. Target LDL-C levels are 80 mg/dL for primary prevention, and 70 mg/dL for secondary prevention. If these levels are not achieved, doses are gradually increased (e.g. Rosuvastatin (10 mg/day), Rosuvastatin (10 mg/day) + another hypolipidemic drug).
10 mg Pravastatin will be orally administered once daily for two years. Target LDL-C levels are in compliance with JASGL2007. If these levels are not achieved, doses are gradually increased (e.g. Pravastatin (20 mg/day), Pravastatin (20 mg/day) + another hypolipidemic drug).

Outcome(s)

• Primary Outcome: % change from baseline in mean-IMT at the end of 24 months.
• Secondary Outcome: 1) Time to % change in mean-IMT. 2) Time to % change in max-IMT of the distal wall of the common carotid artery (IMT-Cmax-distal wall). 3) Time to % change in IMT-Cmax of common carotid artery, IMT-Bmax of carotid sinus, and IMT-Imax of internal carotid artery. 4) Percentage of cases in which mean-IMT decreased at the end of 12 months and 24 months. 5) Time to % change in LDL-C / HDL-C ratio. 6) Percentage of cases in which LDL-C / HDL-C ratio <=1.5 at the end of 12 months and 24 months. 7) Percentage of cases in which LDL-C / HDL-C ratio <=2.0 at the end of 12 months and 24 months. 8) Correlation between LDL-C / HDL-C ratio and max-IMT. 9) Correlation between LDL-C / HDL-C ratio and mean-IMT. 10) Time to % change of serum lipids (LDL-C, HDL-C, and TG), HbA1c, systolic blood pressure, and diastolic blood pressure. 11) JASGL2007 achievement ratio according to the management target level of LDL-C . 12) Cumulative incidence and content of cardiovascular and cerebral vascular events.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: (1) Patients that require lipid-lowering therapy other than the study drug or specified lipid-lowering drugs (anion-exchange resin, probucol, and ethyl icosapentate (EPA)) (2) Patients who have taken statins within one month before the start of the clinical trial. (3) Patients suspected of having serious carotid artery stenosis (greater than 80%) or having serious calcification. (4) Patients with familial hypercholesterolemia or secondary hypercholesterolemia. (5) Patients with fasting serum TG >= 400 mg/dL. (6) Patients with a history of sensitivity to statins. (7) Patients with uncontrolled hypertension. (8) Patients with Type I diabetes or uncontrolled Type II diabetes. (9) Patients who have experienced myocardial infarction or a cerebral stroke within 3 months or Patients with serious heart failure (NYHA class III to IV). (10) Patients with active hepatic disease. (11) Patients with renal disorder (Cr >= 2.0 mg/dL or Ccr < 30 mL/min/1.73m2). (12) Patients with CK > 500 IU/L. (13) Patients currently being treated with cyclosporine. (14) Patients that are pregnant or potentially pregnant, patients breast-feeding, or patients aiming to become pregnant during the clinical trial. (15) Patients with or suspected of having a malignant tumor, or patients with a history of malignant tumor except for the patients in whom recurrences have not been confirmed by routine observation after treatment. (16) Patients with hypothyroidism, hereditary muscular diseases (muscular dystrophy, etc.) or familial history of these diseases. Patients with history of drug-related muscular disorder. (17) Patients with drug abuse or alcoholic. (18) Patients who are ineligible in the opinion of the investigator.

Related Information

• Primary Sponsor: Japan Atherosclerosis Regressive Treatment Study Group
• Source(s) of Monetary Support: Japan Heart Foundation