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

ASCVD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03494270
• Other study ID #: YMC033
• Status: Completed
• Phase: Phase 4
• Start date: March 18, 2018
• Est. completion date: September 26, 2019

Study information

• Verified date: December 2019
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: September 26, 2019
• Est. primary completion date: September 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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:

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

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

? 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

Related Conditions & MeSH terms

• ASCVD

Intervention

Drug:
• Rosuvamibe
Rosuvastatin 10mg/Ezetimibe 10mg
• Monorova
Rosuvastatin 20mg

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to week 12 in LDL-C level		Baseline, Week 12
Secondary	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
Secondary	Change from baseline to week 12 and week 24 in high-sensitivity C-reactive protein (hs-CRP)		Baseline, Week 12, Week 24
Secondary	Change from baseline to week 12 and week 24 in fasting plasma glucose (FPG)		Baseline, Week 12, Week 24
Secondary	Change from baseline to week 12 and week 24 in homeostasis model assessment for insulin resistance (HOMA-IR)		Baseline, Week 12, Week 24
Secondary	Proportion of subjects achieving LDL-C < 70mg/dL		Baseline, Week 12, Week 24
Secondary	Occurrence of Statin-Associated Muscle Symptoms (SAMS)		Up to 24 weeks
Secondary	Proportion of subjects with CPK 4 x upper limit of normal (ULN) or 10 x ULN		Baseline, Week 12, Week 24
Secondary	Proportion of subjects with AST or ALT levels elevated to 4 x ULN or 10 x ULN		Baseline, Week 12, Week 24
Secondary	Occurrence of MACCE (Major Adverse Cardiovascular and Cerebrovascular Event)		Up to 24 weeks