High-intensity Rosuvastatin and Moderate-intensity Rosuvastatin/Ezetimibe in ASCVD Patients

• Status: Completed
• Trial end date: 2019-09-26
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy and safety of high-intensity rosuvastatin and moderate-intensity rosuvastatin/ezetimibe in ASCVD patients.

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

Details

• Lead Sponsor: Yuhan Corporation
• Treatments: Ezetimibe; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

1. Aged 19 to 75 years

2. Patients diagnosed with ASCVD (coronary artery disease)

• acute coronary syndrome

• history of myocardial infarction (MI)

• stable or unstable angina

• history of coronary revascularization

• stroke or transient ischemic attack (TIA)

• peripheral arterial disease, history of peripheral arterial revascularization

3. Taking a stable dose of a statin or a lipid-lowering agent of ezetimibe over 4 weeks before randomization

4. Written informed consent

Exclusion Criteria:

1. Administration of other lipid lowering agents than statin or ezetimibe within 3 months prior to screening visit

2. Fasting triglyceride ≥ 400 mg/dL

3. History of muscular disease or rhabdomyolysis due to use of statin

4. Hypersensitive to rosuvastatin or ezetemibe

5. Contraindications stated in the SPC of rosuvastatin or rosuvastatin/ezetimibe including the following:

① Severe renal disease (CrCL < 30mL/min: Cockcroft-gault formula or estimated GFR (MDRD) < 30mL/min/1.73m2)

② ALT, AST > 3x ULN or history of active liver disease

③ CPK > 3x ULN

6. Administration of other investigational products within 30 days prior to screening visit

7. Other than the above who is deemed to be ineligible to participate in the trial by investigator