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

• Sponsor: Yuhan Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03494270
• Collaborator: (none)
• Enrollment: 270
• Location: 1
• Arms: 2
• Actual Duration (Months): 18.3
• Patients Per Site Per Month: 14.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
ASCVD	Drug: Rosuvamibe; Drug: Monorova	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 270 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Open, Parallel, Multicenter, Phase 4 Study to Compare High-intensity Rosuvastatin to Moderate-intensity Rosuvastatin/Ezetimibe in Atherosclerotic Cardiovascular Disease (ASCVD) Patients
• Actual Study Start Date: Mar 18, 2018
• Actual Primary Completion Date: Sep 26, 2019
• Actual Study Completion Date: Sep 26, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change from baseline to week 12 in LDL-C level [Baseline, Week 12]

Secondary Outcome Measures

1. 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]

2. Change from baseline to week 12 and week 24 in high-sensitivity C-reactive protein (hs-CRP) [Baseline, Week 12, Week 24]

3. Change from baseline to week 12 and week 24 in fasting plasma glucose (FPG) [Baseline, Week 12, Week 24]

4. Change from baseline to week 12 and week 24 in homeostasis model assessment for insulin resistance (HOMA-IR) [Baseline, Week 12, Week 24]

5. Proportion of subjects achieving LDL-C < 70mg/dL [Baseline, Week 12, Week 24]

6. Occurrence of Statin-Associated Muscle Symptoms (SAMS) [Up to 24 weeks]

7. Proportion of subjects with CPK 4 x upper limit of normal (ULN) or 10 x ULN [Baseline, Week 12, Week 24]

8. Proportion of subjects with AST or ALT levels elevated to 4 x ULN or 10 x ULN [Baseline, Week 12, Week 24]

9. Occurrence of MACCE (Major Adverse Cardiovascular and Cerebrovascular Event) [Up to 24 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

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

2. 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

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam		Korea, Republic of

Sponsors and Collaborators

• Yuhan Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yuhan Corporation
• ClinicalTrials.gov Identifier: NCT03494270
• Other Study ID Numbers: YMC033
• First Posted: Apr 11, 2018
• Last Update Posted: Dec 30, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Dec 30, 2019