Methods |
Parallel randomised study |
Participants |
Inclusion criteria:
dyslipidaemic patients under treatment with fibrates, whose LDL‐C levels do not meet those recommended by Japan Atherosclerosis Society Guidelines for prevention of Atherosclerotic Cardiovascular Disease;
patients who have aortic atherosclerotic plaques detected by MRI;
outpatients;
participants who gave written informed consent;
age: 20‐80 years‐old.
Exclusion criteria:
allergy against ezetimibe;
under treatment with statins;
poorly‐controlled hypertension (DBP >110 mmHg);
poorly‐controlled diabetes (HbA1c>10.0 %);
history of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient‐treatments within 6 months;
either level of AST or ALT exceeds three‐fold of the normal limits;
chronic renal failure (serum creatinine>2.0 mg/dl);
malignancies or other diseases with poor prognosis;
pregnant;
participants whose doctor in charge did not agree to join the trial.
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Interventions |
Fibrate monotherapy versus fibrate‐ezetimibe combination |
Outcomes |
Area of atherosclerotic plaques in aorta detected by MRI, 12/24 months after randomisation
Serum lipids (total/LDL/HDL‐cholesterol, triglycerides), 6/12/24 months after randomisation
Flow‐mediated vasodilation in forearm, 6 months after randomisation
Heparin‐releasable extracellular superoxide dismutase (EC‐SOD) levels, 6 months after randomisation
Markers indicating obesity (e.g. adiponectin), inflammation (high‐sensitive C‐reactive protein), oxidative stress, early‐staged kidney diseases (microalbuminuria), 6/12/24 months after randomisation
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Notes |
Date of registration: 03/01/2010 Recruitment status: Terminated Location: Japan Contact information: Katsunori Ikewaki; katsunorike@ndmc.ac.jp Expected completion date: unknown Contacted trialists to ask about status and anticipated completion date, but no response. |