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Completed

NCT Number: NCT03494270

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

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

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Key information

Conditions

ASCVD

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Bundang Hospital

Seongnam, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 19 to 75 years
  • 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
  • Taking a stable dose of a statin or a lipid-lowering agent of ezetimibe over 4 weeks before randomization
  • Written informed consent

Exclusion criteria

  • Administration of other lipid lowering agents than statin or ezetimibe within 3 months prior to screening visit
  • Fasting triglyceride ≥ 400 mg/dL
  • History of muscular disease or rhabdomyolysis due to use of statin
  • Hypersensitive to rosuvastatin or ezetemibe
  • 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

  • Administration of other investigational products within 30 days prior to screening visit
  • Other than the above who is deemed to be ineligible to participate in the trial by investigator

Treatment and study plan

Rosuvamibe

Drug

Rosuvastatin 10mg/Ezetimibe 10mg

Monorova

Drug

Rosuvastatin 20mg

Primary outcomes

  1. Change from baseline to week 12 in LDL-C level

    Time frame: Baseline, Week 12

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 11, 2018
Registry last updated
Dec 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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