Prospective, randomized, open-label, clinical trial comparing rosuvastatin monotherapy and combination therapy with ezetimibe on progression of atherosclerotic plaques and endothelial function

Prospective, randomized, open-label, clinical trial comparing rosuvastatin monotherapy and combination therapy with ezetimibe on progression of atherosclerotic plaques and endothelial function - Clinical trial comparing rosuvastatin monotherapy and combination therapy with ezetimibe

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011745

Enrollment

Registered

2013-09-14

Start date

2013-09-14

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia

Interventions

Rosuvastatin monotherapy (titrate the dosage to achieve LDL-C target levels 30% lower than those recommended by the clinical guideline in Japan) Rosuvastatin/ezetimibe combination therapy (titra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ) Dyslipidemic patients whose LDL-C levels did not reach those recommended by Japan Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2) Patients who have aortic atherosclerotic plaques detected by MRI 3) Outpatients 4) Subjects who gave written informed consent

Exclusion criteria

Exclusion criteria: 1) Allergy against rosuvastatin or ezetimibe 2) Poor-controlled diabetes (HbA1c>10.0 %) 3) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months 4) Either level of aspartate aminotransaminase or alanine aminotransferase exceeds three-fold of the normal limits. 5) End stage renal disease 6) Symptomatic (NYHA III or IV) congestive heart failure 7) Malignancies or other diseases with poor prognosis 8) Pregnant 9) Subjects whose doctor in charge do not agree to join the trial

Design outcomes

Primary

Measure	Time frame
(1) Carotid atherosclerosis evaluated by ultrasound (Intima-media thickness; IMT (meanIMT/maxIMT) and plaque score) 12/24 months after randomization (2) Area and thickness of atherosclerotic plaques in aorta detected by magnetic resonance imaging (MRI) 12/24 months after randomization (3) Flow-mediated vasodilation in forearm 6 months after randomization	—

Secondary

Measure	Time frame
(1) Ankle/brachial index and cardio ankle vascular index (2) Markers for diabetes (hemoglobin A1c, glycoalbumin, blood glucose) (3) Serum lipids (4) Markers indicating obesity (e.g. adiponectin) (5) Markers indicating inflammation (e.g. high sensitive CRP) (6) Markers indicating oxidative stress (8-OHdG/ MDA-LDL) (7) Markers indicating chronic renal diseases (urine albumin/L-FABP) (8) Blood/urine urate levels (9) Body weight/waist circumference (10) Blood pressures	—

Measure

Time frame

(1) Ankle/brachial index and cardio ankle vascular index (2) Markers for diabetes (hemoglobin A1c, glycoalbumin, blood glucose) (3) Serum lipids (4) Markers indicating obesity (e.g. adiponectin) (5) Markers indicating inflammation (e.g. high sensitive CRP) (6) Markers indicating oxidative stress (8-OHdG/ MDA-LDL) (7) Markers indicating chronic renal diseases (urine albumin/L-FABP) (8) Blood/urine urate levels (9) Body weight/waist circumference (10) Blood pressures

—

Countries

Japan

Contacts

Public ContactMakoto Ayaori

National Defense Medical College Department of Internal Medicine

ayaori@ndmc.ac.jp04-2995-1617

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026