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

Phase 4

Completed

• Conditions: Atherosclerotic Cardiovascular Disease; Type 2 Diabetes Mellitus
• Interventions: Drug: Monorova; Drug: Rosuvamibe

• Registration Number: NCT03597412
• Lead Sponsor: Yuhan Corporation

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-13
• Study First Submitted QC: 2018-07-13
• Study First Posted: 2018-07-24
• Study Start: 2018-10-17
• Primary Completion: 2020-08-12
• Study Completion: 2020-08-12
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 236

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monorova Tab	Monorova	Rosuvastatin 20mg qd for 24 weeks
Rosuvamibe Tab	Rosuvamibe	Rosuvastatin 10mg/Ezetimibe 10mg qd for 24 weeks

Primary Outcome Measures

Name	Time	Method
Change from baseline to week 24 in LDL-C level	Baseline, Week 24

Secondary Outcome Measures

Name	Time	Method
Change from baseline to week 12 in LDL-C level	Baseline, Week 12
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 high-sensitivity C-reactive protein (hs-CRP)	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
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
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 fasting plasma glucose (FPG)	Baseline, Week 12, Week 24
Occurrence of MACCE (Major Adverse Cardiovascular and Cerebrovascular Event)	Up to 24 weeks
Proportion of subjects achieving LDL-C < 70mg/dL	Baseline, Week 12, Week 24

Trial Locations

Locations (1)

Kangbuk Samsung Hospital; 🇰🇷 Seoul, Korea, Republic of