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

Primary Purpose

Atherosclerotic Cardiovascular Disease, Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rosuvamibe
Monorova
Sponsored by
Yuhan Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atherosclerotic Cardiovascular Disease

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kangbuk Samsung Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rosuvamibe Tab

Monorova Tab

Arm Description

Rosuvastatin 10mg/Ezetimibe 10mg qd for 24 weeks

Rosuvastatin 20mg qd for 24 weeks

Outcomes

Primary Outcome Measures

Change from baseline to week 24 in LDL-C level

Secondary Outcome Measures

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

Full Information

First Posted
July 13, 2018
Last Updated
December 11, 2020
Sponsor
Yuhan Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03597412
Brief Title
Rosuvastatin/Ezetimibe Versus Rosuvastatin in ASCVD Patients With Type 2 DM
Acronym
MIRA
Official Title
Efficacy and Safety of Rosuvastatin/Ezetimibe Combination Therapy Versus Rosuvastatin Monotherapy in Atherosclerotic Cardiovascular Disease (ASCVD) Patients With Type 2 Diabetes Mellitus (DM)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
October 17, 2018 (Actual)
Primary Completion Date
August 12, 2020 (Actual)
Study Completion Date
August 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yuhan Corporation

4. Oversight

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

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerotic Cardiovascular Disease, Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
236 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rosuvamibe Tab
Arm Type
Experimental
Arm Description
Rosuvastatin 10mg/Ezetimibe 10mg qd for 24 weeks
Arm Title
Monorova Tab
Arm Type
Active Comparator
Arm Description
Rosuvastatin 20mg qd for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Rosuvamibe
Intervention Description
Rosuvastatin 10mg/Ezetimibe 10mg
Intervention Type
Drug
Intervention Name(s)
Monorova
Intervention Description
Rosuvastatin 20mg
Primary Outcome Measure Information:
Title
Change from baseline to week 24 in LDL-C level
Time Frame
Baseline, Week 24
Secondary Outcome Measure Information:
Title
Change from baseline to week 12 in LDL-C level
Time Frame
Baseline, Week 12
Title
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
Title
Change from baseline to week 12 and week 24 in high-sensitivity C-reactive protein (hs-CRP)
Time Frame
Baseline, Week 12, Week 24
Title
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
Title
Change from baseline to week 12 and week 24 in glycosylated hemoglobin (HbA1c)
Time Frame
Baseline, Week 12, Week 24
Title
Change from baseline to week 12 and week 24 in fasting plasma glucose (FPG)
Time Frame
Baseline, Week 12, Week 24
Title
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
Title
Proportion of subjects achieving LDL-C < 70mg/dL
Time Frame
Baseline, Week 12, Week 24
Title
Proportion of subjects achieving LDL-C < 55mg/dL
Time Frame
Baseline, Week 12, Week 24
Title
Occurrence of MACCE (Major Adverse Cardiovascular and Cerebrovascular Event)
Time Frame
Up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Kangbuk Samsung Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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