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

Phase 4

Completed

• Conditions: ASCVD
• Interventions: Drug: Monorova; Drug: Rosuvamibe

• Registration Number: NCT03494270
• Lead Sponsor: Yuhan Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-18
• Study First Submitted: 2018-04-02
• Study First Submitted QC: 2018-04-09
• Study First Posted: 2018-04-11
• Primary Completion: 2019-09-26
• Study Completion: 2019-09-26
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-27
• Last Update Posted: 2019-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monorova Tab	Monorova	Rosuvastatin 20mg qd for 24 weeks
Rosuvamibe Tab	Rosuvamibe	Rosuvastatin 10mg/Ezetimibe 10mg qd for 24 weeks

Primary Outcome Measures

Name	Time	Method
Change from baseline to week 12 in LDL-C level	Baseline, Week 12

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with CPK 4 x upper limit of normal (ULN) or 10 x ULN	Baseline, Week 12, Week 24
Proportion of subjects with AST or ALT levels elevated to 4 x ULN or 10 x ULN	Baseline, Week 12, Week 24
Occurrence of MACCE (Major Adverse Cardiovascular and Cerebrovascular Event)	Up to 24 weeks
Change from baseline to week 12 and week 24 in total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), Non-HDL cholesterol, Apolipoprotein A1, and Apolipoprotein B	Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in high-sensitivity C-reactive protein (hs-CRP)	Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in fasting plasma glucose (FPG)	Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in homeostasis model assessment for insulin resistance (HOMA-IR)	Baseline, Week 12, Week 24
Proportion of subjects achieving LDL-C < 70mg/dL	Baseline, Week 12, Week 24
Occurrence of Statin-Associated Muscle Symptoms (SAMS)	Up to 24 weeks

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of