Clinical trial NCT03597412: Rosuvastatin/Ezetimibe Versus Rosuvastatin in ASCVD Patients With Type 2 DM
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atherosclerotic Cardiovascular Disease
Type 2 Diabetes Mellitus
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2018-07-24
Enrollment: 236
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Change from baseline to week 24 in LDL-C level
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Change from baseline to week 12 in LDL-C level
timeFrame: Baseline, Week 12
measure: Change from baseline to week 12 and week 24 in total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG)
timeFrame: Baseline, Week 12, Week 24
measure: Change from baseline to week 12 and week 24 in high-sensitivity C-reactive protein (hs-CRP)
timeFrame: Baseline, Week 12, Week 24
measure: Change from baseline to week 12 and week 24 in Apolipoprotein A1, Apolipoprotein B, Apolipoprotein B48, and Apolipoprotein B/Apolipoprotein A1
timeFrame: Baseline, Week 24
measure: Change from baseline to week 12 and week 24 in glycosylated hemoglobin (HbA1c)
timeFrame: Baseline, Week 12, Week 24
measure: Change from baseline to week 12 and week 24 in fasting plasma glucose (FPG)
timeFrame: Baseline, Week 12, Week 24
measure: Change from baseline to week 12 and week 24 in homeostasis model assessment for insulin resistance (HOMA-IR)
timeFrame: Baseline, Week 12, Week 24
measure: Proportion of subjects achieving LDL-C < 70mg/dL
timeFrame: Baseline, Week 12, Week 24
measure: Proportion of subjects achieving LDL-C < 55mg/dL
timeFrame: Baseline, Week 12, Week 24
measure: Occurrence of MACCE (Major Adverse Cardiovascular and Cerebrovascular Event)
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
Study officials:
References: