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

RecruitingPhase 4Ages 19 Years - anyAllSeoul National University Bundang Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Cilostazol
  • Aspirin
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Where

1 site
Seoul National University Bundang Hospital
Seongnam-si, South Korea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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