Investigation of MDCT Plaque Assessment in patients receiving Cholesterol lowering with Pitavastatin (IMPACT)

UMIN ID: UMIN000001495

Registered date:11/11/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Patients with non-calcified coronary plaque detected with MDCT
• Date of first enrollment: 2008/10/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

pitavastatin 2mg per day orally for 12 months.
Stopping smoking, life style change and increasing exercise are reccomended. When the decrease in cholesterol level is not satisfactory, plavastatin will be administered.

Outcome(s)

• Primary Outcome: The comparison of the plaque CT value change between the groups
• Secondary Outcome: a. The relationship between plaque CT value and the cholesterol level. b.The relationship between plaque CT value and the oxidative stress and inflamation marker. c. The change of HbH1c between the groups

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 90years-old
• Gender: Male and Female
• Exclude criteria: 1)The stenosis at the lesion where the plaque CT value estimation planned is more than 90%(AHA criteria). 2)Patients who have undergone previous PCI on the lesion site where the evaluation of coronary plaque CT value is planned. 3)Patients who might undergo PCI on the lesion where the plaque planned for the estimation of the CT value is located. 4)Patients receiving lipid-lowering drugs (pitavastatin, atorvastatin, rosvastatin). 5)Patients with familial hypercholesterolemia. 6)Patients with cardiogenic shock. 7)Patients receiving cyclosporine. 8)Patients with any allergy to pitavastatin 9)Patients with any allergy to contrast medium 10)Patients with hepatobiliary disorders. 11)Pregnant women, women suspected of being pregnant, or lactating women. 12)Patients with renal disorders or undergoing dialysis. 13)Patients who are ineligible in the opinion of the investigator.

Related Information

• Primary Sponsor: Yamaguchi University Graduate School of Medicine,Department of Medicine and Clinical Science
• Source(s) of Monetary Support: Yamaguchi University Graduate School of Medicine,Department of Medicine and Clinical Science