Cilostazol and Aspirin to Prevent Heart and Brain Events in Type 2 Diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multi-center, randomized Phase 4 trial compares cilostazol and aspirin for preventing major adverse cardiac and cerebrovascular events in high-risk adults with type 2 diabetes. Eligible participants have subclinical atherosclerosis or metabolic syndrome and meet specific vascular risk criteria, with HbA1c up to 9.9%. The study evaluates whether the combination therapy is effective and safe for reducing MACCE compared with standard expectations, based on a real-world, high-risk diabetic population. Enrollment is centered at Seoul National University Bundang Hospital in Korea. The trial seeks to inform whether adding cilostazol to aspirin offers additional protection against cardiovascular complications in this group.

Why it matters

Who can join: the full rules

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

Where it's running

• Seoul National University Bundang Hospital
  Seongnam-si, Gyeonggi-do, South Korea Recruiting

Study contacts

• Study coordinator: Soo Lim
• Email: limsoo@snu.ac.kr
• Phone: 82-10-9766-2706

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.