Rosuvastatin/Ezetimibe Versus Rosuvastatin in ASCVD Patients With Type 2 DM (MIRA)

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus; Atherosclerotic Cardiovascular Disease
• Intervention / Treatment: Drug: Rosuvamibe; Drug: Monorova

• Study Type: Interventional
• Enrollment (Actual): 236
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Kangbuk Samsung Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Aged 19 and above
2. Patient with type 2 diabetes taking oral diabetes medication for at least 3 months

3. 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
4. Written informed consent

Exclusion Criteria:

1. Type 1 diabetes
2. HbA1c > 8.5% at screening
3. Fasting triglyceride ≥ 400 mg/dL at screening
4. History of muscular disease or rhabdomyolysis due to use of statin
5. Hypersensitive to rosuvastatin or ezetemibe

6. 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

7. Those participating in clinical trials of other drugs
8. Other than the above who is deemed to be ineligible to participate in the trial by investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline to week 24 in LDL-C level	Baseline, Week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline to week 12 in LDL-C level	Baseline, Week 12
Change from baseline to week 12 and week 24 in high-sensitivity C-reactive protein (hs-CRP)	Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in fasting plasma glucose (FPG)	Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in homeostasis model assessment for insulin resistance (HOMA-IR)	Baseline, Week 12, Week 24
Proportion of subjects achieving LDL-C < 70mg/dL	Baseline, Week 12, Week 24
Occurrence of MACCE (Major Adverse Cardiovascular and Cerebrovascular Event)	Up to 24 weeks
Change from baseline to week 12 and week 24 in total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG)	Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in Apolipoprotein A1, Apolipoprotein B, Apolipoprotein B48, and Apolipoprotein B/Apolipoprotein A1	Baseline, Week 24
Change from baseline to week 12 and week 24 in glycosylated hemoglobin (HbA1c)	Baseline, Week 12, Week 24
Proportion of subjects achieving LDL-C < 55mg/dL	Baseline, Week 12, Week 24

Collaborators and Investigators

• Sponsor: Yuhan Corporation

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 17, 2018
• Primary Completion (ACTUAL): August 12, 2020
• Study Completion (ACTUAL): August 12, 2020

Study Registration Dates

• First Submitted: July 13, 2018
• First Submitted That Met QC Criteria: July 13, 2018
• First Posted (ACTUAL): July 24, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 14, 2020
• Last Update Submitted That Met QC Criteria: December 11, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Endocrine System Diseases; Cardiovascular Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Atherosclerosis
• Other Study ID Numbers: YMC038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No