Efficacy and Safety of Combination Therapy of Moderate-intensity Statin and Ezetimibe Compared to High-intensity Statin

• Status: Completed
• Trial end date: 2019-09-17
• Target enrollment: 0
• Participant gender: All

Summary

This study is a multicenter, randomized, open-label, parallel, phase IV trial.

The purpose of this study efficacy and safety of combination therapy of moderate-intensity statin and ezetimibe compared to high-intensity statin.

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

Details

• Lead Sponsor: Seoul National University Bundang Hospital
• Collaborator: Yuhan Corporation
• Treatments: Ezetimibe; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

1. Aged between 19 and 75 years

2. Presence of atherosclerotic cardiovascular disease Coronary artery disease

• History of acute coronary syndrome

• Stable or unstable angina

• History of coronary revascularization Stroke or TIA Peripheral arterial disease, history of peripheral arterial revascularization

3. Patients who have been taking lipid-lowering agents (statin or ezetimibe) for ≥4 weeks at the time of randomization

4. Patients who gave informed consent

Exclusion Criteria:

1. Patients who have used lipid-lowering agents other than statin or ezetimibe within the last 3 months

2. A serum triglyceride on fasting >400 mg/dL

3. A history of muscular symptoms or rhabdomyolysis due to the use of statin

4. Hypersensitivity to rosuvastatin or ezetimibe

5. Labeled contraindications to rosuvastatin or rosuvastatin Severe renal impairment (CrCl <30 mL/min by Cockcroft-Gault formula or estimated GFR <30 mL/min / 1.73 m2 by MDRD equation) ALT, AST ≥3 × ULN or active liver disease CPK ≥3 × ULN

6. Enrollment of other clinical trials within 30 days

7. Any other issues that the treating physician assumes ineligible for participation in the trial