NCT07719894RecruitingPhase 4
Cilostazol and Aspirin for Cardiovascular Event Prevention in Patients With Type 2 Diabetes
Comparison of Efficacy and Safety Between Aspirin and Cilostazol on Cardiovascular Event in Patients at High Risk of Cardiovascular Disease, Randomization.
Source: ClinicalTrials.gov · Last updated 22 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 1200 (estimated)
- First submitted
- 15 Jul 2026
- Start date
- 6 May 2026
- Primary completion date
- Dec 2028
- Lead sponsor
- Seoul National University Bundang Hospital
- Diseases
- Type 2 diabetes
- NCT number
- NCT07719894
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 1200
- From 6 May 2026 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Individuals currently taking antiplatelet or antithrombotic agents
Other illness
- 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 liver enzyme levels greater than 3 times the upper limit of normal or chronic liver disease
- Patients with a history of hypersensitivity to any component of the study drugs
Lab values
- Patients with QT prolongation
Other
- Patients with severe renal dysfunction, defined as estimated glomerular filtration rate \< 30 mL/min/1.73 m²
- Individuals who are pregnant or breastfeeding
- Patients with complications of coronary artery stenosis
- 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
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.