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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03494270
Recruitment Status : Completed
First Posted : April 11, 2018
Last Update Posted : December 30, 2019
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation

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

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Study Type : Interventional  (Clinical Trial)
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 : March 18, 2018
Actual Primary Completion Date : September 26, 2019
Actual Study Completion Date : September 26, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change from baseline to week 12 in LDL-C level [ Time Frame: 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 [ Time Frame: Baseline, Week 12, Week 24 ]
  2. Change from baseline to week 12 and week 24 in high-sensitivity C-reactive protein (hs-CRP) [ Time Frame: Baseline, Week 12, Week 24 ]
  3. Change from baseline to week 12 and week 24 in fasting plasma glucose (FPG) [ Time Frame: Baseline, Week 12, Week 24 ]
  4. Change from baseline to week 12 and week 24 in homeostasis model assessment for insulin resistance (HOMA-IR) [ Time Frame: Baseline, Week 12, Week 24 ]
  5. Proportion of subjects achieving LDL-C < 70mg/dL [ Time Frame: Baseline, Week 12, Week 24 ]
  6. Occurrence of Statin-Associated Muscle Symptoms (SAMS) [ Time Frame: Up to 24 weeks ]
  7. Proportion of subjects with CPK 4 x upper limit of normal (ULN) or 10 x ULN [ Time Frame: Baseline, Week 12, Week 24 ]
  8. Proportion of subjects with AST or ALT levels elevated to 4 x ULN or 10 x ULN [ Time Frame: Baseline, Week 12, Week 24 ]
  9. Occurrence of MACCE (Major Adverse Cardiovascular and Cerebrovascular Event) [ Time Frame: Up to 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494270


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of
Sponsors and Collaborators
Yuhan Corporation
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Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT03494270    
Other Study ID Numbers: YMC033
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: December 30, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No