Coronary imaging by multislice detector computed tomography in aggressive lipid intervention study (CRYSTAL)

UMIN ID: UMIN000001204

Registered date:01/08/2008

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Patients with coronary artery disease who underwent PCI
• Date of first enrollment: 2008/07/01
• Target sample size: 300
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Control therapy: Lipid-lowering therapy with 1 to 4 mg pitavastatin daily for a period of 45 months to achieve LDL-C<100mg/dL
Aggressive therapy: Lipid-lowering therapy with 1 to 4 mg pitavastatin daily for a period of 45 months to achieve LDL-C<70mg/dL

Outcome(s)

• Primary Outcome: Changes in the coronary plaque distribution and coronary plaque CT values
• Secondary Outcome: 1) Changes in LDL-C, TG, HDL-C 2) Correlation between the absolute and percent changes of LDL-C and changes in the coronary plaque distribution 3) Correlation between the absolute and percent changes of LDL-C and changes in the coronary plaque density 4) Correlation between the absolute and percent changes in the blood test results (lipids, oxidative stress markers, adipocytokines) and changes in the coronary plaque distribution 5) Correlation between the absolute and percent change in the blood test results (lipids, oxidative stress markers, adipocytokines) and changes in the coronary plaque values 6) Incidence of major adverse cardiovascular events (MACE; defined as cardiac death, nonfatal MI, PCI or coronary artery bypass grafting, hospitalization due to angina, fatal or nonfatal stroke or TIA) 7) All-cause mortality

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Patients scheduled to undergo CABG during the treatment period 2) Patients on steroid treatment 3) Non-availability of evaluable CT images 4) Patients with malignant disease 5) Patients on treatment with fibrates or nicotinic acid 6) Patients with a history of hypersensitivity to any of the components of the product 7) Patients with liver dysfunction (AST or ALT values of >=100IU) or the following diseases considered to be associated with biliary obstruction and/or defective hepatic metabolism: acute hepatitis, acute exacerbation of chronic hepatitis, liver cirrhosis, hepatic carcinoma and/or icterus 8) Patients on cyclosporine therapy 9) Pregnant and possibly pregnant women, lactating women 10) Patients with renal dysfunction (serum creatinine >=2.0 mg/dL) or dialysis patients 11) Patients who are judged by the principal or other investigators to be not eligible for enrollment in the study

Related Information

• Primary Sponsor: Department of Advanced Cardiovascular Therapeutics, Osaka University Graduate School of Medicine
• Secondary Sponsor: Nozaki Tokushukai Hospital, and Nagoya Tokushukai General Hospital
• Source(s) of Monetary Support: None