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

A Randomized, Open, Parallel, Multicenter, Phase 4 Study to Compare High-intensity Rosuvastatin to Moderate-intensity Rosuvastatin/Ezetimibe in Atherosclerotic Cardiovascular Disease (ASCVD) Patients

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

Study Overview

• Status: Completed
• Conditions: ASCVD
• Intervention / Treatment: Drug: Rosuvamibe; Drug: Monorova

• Study Type: Interventional
• Enrollment (Actual): 270
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seongnam, Korea, Republic of
    • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rosuvamibe Tab; Rosuvastatin 10mg/Ezetimibe 10mg qd for 24 weeks	Drug: Rosuvamibe; Rosuvastatin 10mg/Ezetimibe 10mg
Active Comparator: Monorova Tab; Rosuvastatin 20mg qd for 24 weeks	Drug: Monorova; Rosuvastatin 20mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline to week 12 in LDL-C level	Baseline, Week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Yuhan Corporation

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2018
• Primary Completion (Actual): September 26, 2019
• Study Completion (Actual): September 26, 2019

Study Registration Dates

• First Submitted: April 2, 2018
• First Submitted That Met QC Criteria: April 9, 2018
• First Posted (Actual): April 11, 2018

Study Record Updates

• Last Update Posted (Actual): December 30, 2019
• Last Update Submitted That Met QC Criteria: December 27, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: YMC033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No