Cilostazol and Aspirin for Cardiovascular Event Prevention in Patients With Type 2 Diabetes

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.

Eligibility

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

Conditions4

Interventions2

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