Atherosclerosis, Type 2 Diabetes Mellitus (T2DM)
Conditions
Keywords
Major Adverse Cardiac and Cerebrovascular Events, Cilostazol, Aspirin
Brief summary
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.
Interventions
DRUGCilostazol
Drug: Cilostazol Other Name: Pletaal SR Capsule
DRUGAspirin
Drug: AspirinOther Name: ASA
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Individuals with type 2 diabetes mellitus were eligible if they were aged ≥19 years * Individuals with subclinical atherosclerosis or metabolic syndrome, defined as at least one of the following: * Carotid intima-media thickness ≥ 1 mm * Ankle-brachial index \< 0.9 - Pulse wave velocity ≥ 9 m/s * Flow-mediated vasodilatation \< 5% * Coronary artery calcium score ≥ 40 * Coronary artery stenosis ≥ 20% or ≤ 70% * Peripheral artery occlusive disease ≥ 20% * Metabolic syndrome * Individuals with HbA1c ≤ 9.9% * Individuals who voluntarily agree to participate in the study and provide written informed consent
Exclusion criteria
* Patients with a history of major cardiovascular events, including myocardial infarction, stroke, or heart failure * Patients with heart failure (NYHA I\~IV) * Patients with current active bleeding or suspected bleeding * Patients with suspected bleeding tendency or hematologic disorder, such as hemophilia or thrombocytopenia * Patients recently diagnosed with gastrointestinal ulcerative disease * Patients with inadequately controlled hypertension, defined as systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg * Patients with severe renal dysfunction, defined as estimated glomerular filtration rate \< 30 mL/min/1.73 m² * Patients with liver enzyme levels greater than 3 times the upper limit of normal or chronic liver disease * Individuals currently taking antiplatelet or antithrombotic agents * Individuals who are pregnant or breastfeeding * Patients with a history of hypersensitivity to any component of the study drugs * Patients with complications of coronary artery stenosis * Patients with QT prolongation * Patients with a sigmoid-shaped ventricular septum or risk of sigmoid-shaped ventricular septum * Individuals with alcohol addiction * Patients with asthma * Patients deemed unsuitable for participation in the study based on the investigator's judgment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) | Up to 156 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Three-Point Major Adverse Cardiovascular Events | Up to 156 weeks | Incidence of three-point major adverse cardiovascular events, including non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death |
| Incidence of Heart Failure Events | Up to 156 weeks | Incidence of heart failure events during the study period |
| Incidence of Peripheral Vascular Events | Up to 156 weeks | Incidence of peripheral vascular events, including limb ischemia, amputation, and revascularization. |
| Change in CK-MB Level | Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks | Change from baseline in serum creatine kinase-MB level. |
| Change in Troponin-I Level | Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks | Change from baseline in serum troponin-I level |
| Change in Fasting Glucose Level | Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks | Change from baseline in fasting glucose level |
| Change in HbA1c Level | Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks | Change from baseline in HbA1c level |
| Change in Insulin Level | Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks | Change from baseline in insulin level |
| Change in Total Cholesterol Level | Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks | Change from baseline in serum total cholesterol level |
| Change in Triglyceride(TG) Level | Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks | Change from baseline in serum TG level |
| Change in HDL Cholesterol Level | Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks | Change from baseline in serum high-density lipoprotein (HDL) cholesterol level |
| Change in LDL Cholesterol Level | Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks | Change from baseline in serum LDL(low-density lipoprotein) cholesterol level |
| Change in hsCRP Level | Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks | Change from baseline in high-sensitivity C-reactive protein level |
| Change in Body Composition | Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks | Change in body composition measured by BIA |
| Change in the Number of Metabolic Syndrome Components | Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks | Change in the number of metabolic syndrome components. |
| Change in Framingham Risk Score | Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks | Change in Framingham Risk Score. Higher scores indicate a higher estimated risk of cardiovascular disease. |
| Change in PREVENT Risk Score | Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks | Change in Predicting Risk of Cardiovascular Disease EVENTs (PREVENT) risk score. Higher scores indicate a higher estimated risk of cardiovascular disease. |
| Change in SCORE2 | Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks | Change in in Systematic COronary Risk Evaluation 2 (SCORE2). Higher scores indicate a higher estimated risk of cardiovascular disease. |
| Change in coronary artery calcium score | Baseline and 156 weeks | 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. |
| Change in Coronary Artery Stenosis | Baseline and 156 weeks | Change in coronary artery stenosis measured by coronary computed tomography angiography |
Countries
South Korea
Contacts
CONTACTSoo Lim
CONTACTJiyoon Lee
Outcome results
None listed