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

Yuhan

Status and phase: Completed; Phase 4

Conditions: ASCVD

Treatments: Drug: Rosuvamibe; Drug: Monorova

Study type: Interventional

Funder types: Industry

Identifiers

NCT03494270

YMC033

Details and patient eligibility

About

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

Enrollment: 270 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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270 participants in 2 patient groups

Rosuvamibe Tab

Experimental group

Description:

Rosuvastatin 10mg/Ezetimibe 10mg qd for 24 weeks

Treatment:

Drug: Rosuvamibe

Monorova Tab

Active Comparator group

Description:

Rosuvastatin 20mg qd for 24 weeks

Treatment:

Drug: Monorova