Patients with non-calcified coronary plaque detected with MDCT
Conditions
Interventions
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
Sponsors
Yamaguchi University Graduate School of Medicine,Department of Medicine and Clinical Science
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with coronary non-calcified plaques detected by MDCT 2)Patients with hypercholesterolemia as defined by any of the following criteria: i) TC >220 mg/dl; ii) LDL-C >140 mg/dl; iii) cholesterol-lowering treatment is necessary in accordance with the investigator's judgement when LDL-C >120 mg/dl or TC >200 mg/dl. 3) Patients 20 years or older at the time of their consent. 4) Patients giving written consent by their own volition after being provided sufficient explanation for participation in this clinical trial.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The comparison of the plaque CT value change between the groups | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactTomoko Nao
Yamaguchi University Graduate School of Medicine Cardiology
Outcome results
None listed