Usual Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin on Coronary Atherosclerotic Plaque

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this prospective, open-label, randomized, single center study is to compare the effect of usual dose rosuvastatin plus ezetimibe and high-dose rosuvastatin on modifying atherosclerotic plaque.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center
• Collaborators: Hanmi Pharm. Co., Ltd.; Hanmi Pharmaceutical co., ltd.
• Treatments: Ezetimibe; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• Among patients who undergo CAG for suspected ischemic heart disease and meet all of the followings:

• Moderate stenosis (30-70%) in coronary artery

• Deferred to medical treatment based on physiologic (FFR, CFR, IMR) or radiologic (IVUS with or without OCT) evaluation.

• Agreement obtained by participant

Exclusion Criteria:

• Severe renal failure(glomerular filtration rate < 30 ml/min/1.73m2, hemodialysis or peritoneal dialysis)

• Active liver disease

• Patient taking Niacin or fibrate(if possible, patient can be enrolled to the study after stopping those medication)

• Medical or family history of myositis, unexplained CK elevation > 3 times ULN at first visit

• Life expectancy < 2 years (judged by investigator)

• Coadministration of cyclosporine

• Untreated hypothyroidism

• Patient with poor compliance including alcohol abuse

• History of hypersensitivity including myotoxicity for either statin or ezetimibe

• Pregnant or breast-feeding woman

• Other conditions inappropriate for enrollment by investigator

• * Eligible patients will be randomly assigned to treatment arms, stratified by diagnosis on admission(acute coronary syndrome or stable ischemic heart disease) and presence of chronic statin use (more than one month)