Pitavastatin or bezafibrate intervention, assessment of antiarteriosclerotic effect (PIONEER)

UMIN ID: UMIN000001130

Registered date:01/08/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Type 2b hyperlipidemia
• Date of first enrollment: 2008/08/01
• Target sample size: 150
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Pitavastatin 2 mg daily for a period of 12 months
Bezafibrate 400 mg daily for a period of 12 months

Outcome(s)

• Primary Outcome: An absolute change of intima-media thickness (IMT) of common carotid artery
• Secondary Outcome: 1) A percent change of serum lipids and apolipoproteins (LDL-C, HDL-C, triglyceride, remnant lipoprotein-C, apoB48) 2) A percent change of serum lipoprotein fractionation 3) A percent change of high sensitive C-reactive protein (hs-CRP) 4) A percent change of adiponectin 5) Relationship between the absolute change in of intima-media thickness (IMT) of common carotid artery and percent change of each marker 6) Change in surface morphology and plaque tissue characterization

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1) Contraindication of Livalo Tab (pitavastatin calcium) - Patients with a history of hypersensitivity to any of the conponents of the product - Patients with severe hepatic disorder or biliary atresia - Patients receiving cyclosporine - Pregnant women, women suspected of being pregnant, or lactating women 2) Contraindication of Bezator SR tab (bezafibrate) - Patients with renal dialysis - Patients with significant renal disease like renal failure - Patients with serum creatinine >/= 2.0 mg/dL - Patients with history of hypersensitivity to any of the ingredients of the product - Pregnant women, women suspected of being pregnant, or lactating women 3) Patients with hepatic disorders (ALT or AST >/= 100IU/L) 4) Patients with HbA1c >/= 9.0% 5) Patients with obvious steonosis in carotid artery 6) Patients who are being treated with insulin 7) Patients whom the principle investigators or other investigators consider unsuitable

Related Information

• Primary Sponsor: The Research group for Arteriosclerosis treatment of The supporting Center for Clinical Research and Education : SCCRE, a nonprofit organization
• Source(s) of Monetary Support: The Research group for Arteriosclerosis treatment of The supporting Center for Clinical Research and Education : SCCRE, a nonprofit organization