Clinical trial NCT03494270: High-intensity Rosuvastatin and Moderate-intensity Rosuvastatin/Ezetimibe in ASCVD Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: ASCVD
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2018-04-11
Enrollment: 270
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline to week 12 in LDL-C level
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: 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
timeFrame: Baseline, Week 12, Week 24
measure: Change from baseline to week 12 and week 24 in high-sensitivity C-reactive protein (hs-CRP)
timeFrame: Baseline, Week 12, Week 24
measure: Change from baseline to week 12 and week 24 in fasting plasma glucose (FPG)
timeFrame: Baseline, Week 12, Week 24
measure: Change from baseline to week 12 and week 24 in homeostasis model assessment for insulin resistance (HOMA-IR)
timeFrame: Baseline, Week 12, Week 24
measure: Proportion of subjects achieving LDL-C < 70mg/dL
timeFrame: Baseline, Week 12, Week 24
measure: Occurrence of Statin-Associated Muscle Symptoms (SAMS)
timeFrame: Up to 24 weeks
measure: Proportion of subjects with CPK 4 x upper limit of normal (ULN) or 10 x ULN
timeFrame: Baseline, Week 12, Week 24
measure: Proportion of subjects with AST or ALT levels elevated to 4 x ULN or 10 x ULN
timeFrame: Baseline, Week 12, Week 24
measure: Occurrence of MACCE (Major Adverse Cardiovascular and Cerebrovascular Event)
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
References: