Treatment with statin on atheroma regression evaluated by intravascular ultrasound with Virtual Histology; TRUTH Study (Kanagawa PTCA Conference Regression Study 5; KPCR5)

UMIN ID: C000000311

Registered date:25/01/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Patients with stable or unstable angina
• Date of first enrollment: 2005/12/01
• Target sample size: 160
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

pitavastain group
pravastatin group

Outcome(s)

• Primary Outcome: Change of tissue characteristics in coronary plaque evaluated by intravascular ultrasound (IVUS) with Virtual Histology

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1)Patients currently medicated with statins or other lipid lowering therapy 2)Patients meeting the contraindications or relative contraindications for pitavastatin and pravastatin 3)Patients with hepatic disorder (AST or ALT greater than 2.5 times of the normal upper limits) 4)Patients with renal dysfunction (serum creatinine 2.0mg/dL or higher) 5)Patients with a history of severe muscular disorder or increased CK (CPK) greater than 2.5 times of the normal upper limit 6)Patients with acute myocardial infarction occurred within 24 hours 7)Patients failed to PCI 8)Patients with cerebrovascular accident occurred within 1 month 9)Patients with concurrent or a history of malignant disease within 5 years 10)Patients receiving LDL apheresis 11)Patients with homozygous familial hypercholesterolemia 12)Patients requiring the following prohibited concomitant drugs 13)Drug abusers 14)Patients participating in other studies 15)Patients ineligible for the study determined by physicians

Related Information

• Primary Sponsor: Kanagawa PTCA Conference
• Source(s) of Monetary Support: Japan Heart Foundation