Skip to main content
. 2018 Nov 19;2018(11):CD012502. doi: 10.1002/14651858.CD012502.pub2

JPRN‐UMIN000002964.

Methods Parallel randomised study
Participants Inclusion criteria:
  1. 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;

  2. patients who have aortic atherosclerotic plaques detected by MRI;

  3. outpatients;

  4. participants who gave written informed consent;

  5. age: 20‐80 years‐old.


Exclusion criteria:
  1. allergy against ezetimibe;

  2. under treatment with statins;

  3. poorly‐controlled hypertension (DBP >110 mmHg);

  4. poorly‐controlled diabetes (HbA1c>10.0 %);

  5. history of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient‐treatments within 6 months;

  6. either level of AST or ALT exceeds three‐fold of the normal limits;

  7. chronic renal failure (serum creatinine>2.0 mg/dl);

  8. malignancies or other diseases with poor prognosis;

  9. pregnant;

  10. participants whose doctor in charge did not agree to join the trial.

Interventions Fibrate monotherapy versus fibrate‐ezetimibe combination
Outcomes
  1. Area of atherosclerotic plaques in aorta detected by MRI, 12/24 months after randomisation

  2. Serum lipids (total/LDL/HDL‐cholesterol, triglycerides), 6/12/24 months after randomisation

  3. Flow‐mediated vasodilation in forearm, 6 months after randomisation

  4. Heparin‐releasable extracellular superoxide dismutase (EC‐SOD) levels, 6 months after randomisation

  5. 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

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.