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

• Status: Completed
• Trial end date: 2020-08-12
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yuhan Corporation
• Treatments: Ezetimibe; Rosuvastatin Calcium

Criteria

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