Patients with type 2 diabetes and cardiovascular risk factors are at increased risk of cardiovascular events. Therefore, a multi-center prospective randomized study will be conducted to compare the efficacy and safety of cilostazol and aspirin for the prevention of major adverse cardiac and cerebrovascular events (MACCE) in high-risk patients with type 2 diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,200
Drug: Cilostazol Other Name: Pletaal SR Capsule
Drug: AspirinOther Name: ASA
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
RECRUITINGIncidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Incidence of major adverse cardiac and cerebrovascular events (MACCE), defined as myocardial infarction, stroke, cardiac or peripheral revascularization, hospitalization for symptomatic vascular ischemia, amputation, hospitalization for heart failure, or cardiovascular disease-related death
Time frame: Up to 156 weeks
Incidence of Three-Point Major Adverse Cardiovascular Events
Incidence of three-point major adverse cardiovascular events, including non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death
Time frame: Up to 156 weeks
Incidence of Heart Failure Events
Incidence of heart failure events during the study period
Time frame: Up to 156 weeks
Incidence of Peripheral Vascular Events
Incidence of peripheral vascular events, including limb ischemia, amputation, and revascularization.
Time frame: Up to 156 weeks
Change in CK-MB Level
Change from baseline in serum creatine kinase-MB level.
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in Troponin-I Level
Change from baseline in serum troponin-I level
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in Fasting Glucose Level
Change from baseline in fasting glucose level
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
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Change in HbA1c Level
Change from baseline in HbA1c level
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in Insulin Level
Change from baseline in insulin level
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in Total Cholesterol Level
Change from baseline in serum total cholesterol level
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in Triglyceride(TG) Level
Change from baseline in serum TG level
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in HDL Cholesterol Level
Change from baseline in serum high-density lipoprotein (HDL) cholesterol level
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in LDL Cholesterol Level
Change from baseline in serum LDL(low-density lipoprotein) cholesterol level
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in hsCRP Level
Change from baseline in high-sensitivity C-reactive protein level
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in Body Composition
Change in body composition measured by BIA
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in the Number of Metabolic Syndrome Components
Change in the number of metabolic syndrome components.
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in Framingham Risk Score
Change in Framingham Risk Score. Higher scores indicate a higher estimated risk of cardiovascular disease.
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in PREVENT Risk Score
Change in Predicting Risk of Cardiovascular Disease EVENTs (PREVENT) risk score. Higher scores indicate a higher estimated risk of cardiovascular disease.
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in SCORE2
Change in in Systematic COronary Risk Evaluation 2 (SCORE2). Higher scores indicate a higher estimated risk of cardiovascular disease.
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in coronary artery calcium score
Change in coronary artery calcium score (CACS) measured by coronary computed tomography angiography The coronary artery calcium score is measured using the Agatston method; the minimum value is 0, there is no fixed maximum value, and higher scores indicate greater coronary artery calcification.
Time frame: Baseline and 156 weeks
Change in Coronary Artery Stenosis
Change in coronary artery stenosis measured by coronary computed tomography angiography
Time frame: Baseline and 156 weeks