Hypercholesterolemia with carotid plaque
Conditions
Interventions
Rosuvastatin will be administered for 96 weeks at a dosage of 5 mg/day. If treatment for 4 weeks fails to reduce the LDL-C level below 120 mg/dL, the dosage can be increased up to 20 mg/day.
Sponsors
Juntendo University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients giving written consent after being provided with sufficient explanation about participation in this clinical trial. 2) Patients aged 20 years or older at the time of giving consent (no limitations on gender or hospitalization status). 3) Patients with hypercholesterolemia and a max-IMT of more than 1.8 mm as measured by ultrasound. 4) Patients with the LDL-C level of more than 120 mg/dL, or patients who have both carotid stenosis and coronary stenosis with the LDL-C level of more than 100 mg/dL.
Exclusion criteria
Exclusion criteria: 1) Patients currently receiving other lipid-lowering drugs apart from the test drug. 2) Patients who have received any HMG-CoA reductase inhibitor (statin) within 3 months before the observation period. 3) Patients with severe carotid stenosis and marked calcification. 4) Patients with the fasting TG level of more than 400 mg/dL. 5) Patients with uncontrolled hypertension (DBP100mmHg or SBP200mmHg throughout the observation period). 6) Patients with familial hypercholesterolemia that cannot be controlled by statin therapy. 7) Patients with secondary hyperlipidemia due to thyroid dysfunction, Cushing's syndrome, nephrotic syndrome, systemic lupus erythematosus, etc. 8) Patients receiving LDL apheresis. 9) Patients on treatment with cyclosporine. 10) Patients with renal dysfunction or on hemodialysis. 11) Patients with a history of severe adverse effects or allergy to statins. 12) Patients with confirmed malignancy, possible malignancy, or a history of malignancy. 13) Patients with active liver disease or hepatic dysfunction (ALT, AST, ALP levels more than 2.5 times the upper limit of normal, or a total bilirubin of more than 3.0 mg/dL). 14) Patients with the serum creatinine of more than 1.5 mg/dL. 15) Patients with the serum creatine kinase (CK) level at least 3 times the upper limit of normal. 16) Patients with contraindications to MRI. 17) Patients cannot be taken their MRI pictures. 18) Patients who are ineligible for any other reason in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percent change of carotid plaque volume and the changes of carotid plaque composition in week 96. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Percent change of carotid plaque volume and qualitative plaque change in week 48. 2) Percent changes of LDL-C and HDL-C, hs-CRP, GFR, LDL-C/HDL-C ratio. 3) Exploration of relation between changes of LDL-C and plaque volume/composition, relation between changes of HDL-C and plaque volume/composition, and relation between changes of hs-CRP and plaque volume/composition. 4) Details and incidence of major adverse cardiac and cerebrovascular events. 5) Relation between hyperinsulinemia and carotid plaque. | — |
Countries
Japan
Contacts
Public ContactKatsumi Miyauchi
Juntendo University School of Medicine Department of Cardiovascular Medicine
Outcome results
None listed