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

Type 2 Diabetes Mellitus Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03597412
• Other study ID #: YMC038
• Status: Completed
• Phase: Phase 4
• Start date: October 17, 2018
• Est. completion date: August 12, 2020

Study information

• Verified date: December 2020
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: August 12, 2020
• Est. primary completion date: August 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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:

? Severe renal disease (CrCL < 30mL/min: Cockcroft-gault formula or estimated GFR (MDRD) < 30mL/min/1.73m2)

? ALT, AST > 3x ULN or history of active liver disease

? 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

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerotic Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Rosuvamibe
Rosuvastatin 10mg/Ezetimibe 10mg
• Monorova
Rosuvastatin 20mg

Locations

Country	Name	City	State
Korea, Republic of	Kangbuk Samsung Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to week 24 in LDL-C level		Baseline, Week 24
Secondary	Change from baseline to week 12 in LDL-C level		Baseline, Week 12
Secondary	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
Secondary	Change from baseline to week 12 and week 24 in high-sensitivity C-reactive protein (hs-CRP)		Baseline, Week 12, Week 24
Secondary	Change from baseline to week 12 and week 24 in Apolipoprotein A1, Apolipoprotein B, Apolipoprotein B48, and Apolipoprotein B/Apolipoprotein A1		Baseline, Week 24
Secondary	Change from baseline to week 12 and week 24 in glycosylated hemoglobin (HbA1c)		Baseline, Week 12, Week 24
Secondary	Change from baseline to week 12 and week 24 in fasting plasma glucose (FPG)		Baseline, Week 12, Week 24
Secondary	Change from baseline to week 12 and week 24 in homeostasis model assessment for insulin resistance (HOMA-IR)		Baseline, Week 12, Week 24
Secondary	Proportion of subjects achieving LDL-C < 70mg/dL		Baseline, Week 12, Week 24
Secondary	Proportion of subjects achieving LDL-C < 55mg/dL		Baseline, Week 12, Week 24
Secondary	Occurrence of MACCE (Major Adverse Cardiovascular and Cerebrovascular Event)		Up to 24 weeks