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Completed

NCT Number: NCT03597412

Rosuvastatin/Ezetimibe Versus Rosuvastatin in ASCVD Patients With Type 2 DM

This study will evaluate the efficacy and aafety of rosuvastatin/ezetimibe combination therapy vs. rosuvastatin monotherapy in atherosclerotic cardiovascular disease patients with type 2 diabetes mellitus

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Key information

Conditions

Atherosclerotic Cardiovascular Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes Mellitus Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kangbuk Samsung Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 19 and above
  • Patient with type 2 diabetes taking oral diabetes medication for at least 3 months
  • Patient diagnosed with ASCVD
  • Myocardial Infarction (MI)
  • Acute coronary syndrome (ACS)
  • History of Coronary revascularization(Percutaneous Coronary Intervention, PCI)
  • History of Coronary artery bypass graft surgery (CABG) or other arterial revascularization procedures
  • Stroke or Transient ischemic attack (TIA)
  • Peripheral Arterial Disease (PAD)
  • Stable Angina
  • Written informed consent

Exclusion criteria

  • Type 1 diabetes
  • HbA1c > 8.5% at screening
  • Fasting triglyceride ≥ 400 mg/dL at screening
  • 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

  • Those participating in clinical trials of other drugs
  • 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 24 in LDL-C level

    Time frame: Baseline, Week 24

Secondary outcomes

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

    Time frame: Baseline, Week 12

  2. Change from baseline to week 12 and week 24 in total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG)

    Time frame: Baseline, Week 12, Week 24

  3. Change from baseline to week 12 and week 24 in high-sensitivity C-reactive protein (hs-CRP)

    Time frame: Baseline, Week 12, Week 24

  4. Change from baseline to week 12 and week 24 in Apolipoprotein A1, Apolipoprotein B, Apolipoprotein B48, and Apolipoprotein B/Apolipoprotein A1

    Time frame: Baseline, Week 24

  5. Change from baseline to week 12 and week 24 in glycosylated hemoglobin (HbA1c)

    Time frame: Baseline, Week 12, Week 24

  6. Change from baseline to week 12 and week 24 in fasting plasma glucose (FPG)

    Time frame: Baseline, Week 12, Week 24

  7. 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

  8. Proportion of subjects achieving LDL-C < 70mg/dL

    Time frame: Baseline, Week 12, Week 24

  9. Proportion of subjects achieving LDL-C < 55mg/dL

    Time frame: Baseline, Week 12, Week 24

  10. 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

Efficacy and Safety of Rosuvastatin/Ezetimibe Combination Therapy Versus Rosuvastatin Monotherapy in Atherosclerotic Cardiovascular Disease (ASCVD) Patients With Type 2 Diabetes Mellitus (DM)

Acronym: MIRA

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 24, 2018
Registry last updated
Dec 14, 2020

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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