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

Yuhan

Status and phase: Completed; Phase 4

Conditions: Atherosclerotic Cardiovascular Disease; Type 2 Diabetes Mellitus

Treatments: Drug: Rosuvamibe; Drug: Monorova

Study type: Interventional

Funder types: Industry

Identifiers

NCT03597412

YMC038

Details and patient eligibility

About

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

Enrollment: 236 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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236 participants in 2 patient groups

Rosuvamibe Tab

Experimental group

Description:

Rosuvastatin 10mg/Ezetimibe 10mg qd for 24 weeks

Treatment:

Drug: Rosuvamibe

Monorova Tab

Active Comparator group

Description:

Rosuvastatin 20mg qd for 24 weeks

Treatment:

Drug: Monorova