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

Recruiting now · Phase 4

Conditions studied: Type 2 Diabetes Mellitus (T2DM), Atherosclerosis

In brief

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.

Key facts

Study ID

NCT07719894

Run by

Seoul National University Bundang Hospital

People needed

1200

Starts

2026-05-06

Expected to finish

2028-12-31

Last updated by the study team

2026-07-22

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea (enrolling)

Full record on ClinicalTrials.gov

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