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NCT Number: NCT07719894

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location status: Recruiting

Location contact

Jiyoon Lee

CONTACT

82-10-4850-4828

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cilostazol

Drug

Drug: Cilostazol Other Name: Pletaal SR Capsule

Aspirin

Drug

Drug: AspirinOther Name: ASA

Primary outcomes

  1. Incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE)

    Time frame: Up to 156 weeks

    Incidence of major adverse cardiac and cerebrovascular events (MACCE), defined as myocardial infarction, stroke, cardiac or peripheral revascularization, hospitalization for symptomatic vascular ischemia, amputation, hospitalization for heart failure, or cardiovascular disease-related death

Secondary outcomes

  1. Incidence of Three-Point Major Adverse Cardiovascular Events

    Time frame: Up to 156 weeks

    Incidence of three-point major adverse cardiovascular events, including non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death

  2. Incidence of Heart Failure Events

    Time frame: Up to 156 weeks

    Incidence of heart failure events during the study period

  3. Incidence of Peripheral Vascular Events

    Time frame: Up to 156 weeks

    Incidence of peripheral vascular events, including limb ischemia, amputation, and revascularization.

  4. Change in CK-MB Level

    Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks

    Change from baseline in serum creatine kinase-MB level.

  5. Change in Troponin-I Level

    Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks

    Change from baseline in serum troponin-I level

  6. Change in Fasting Glucose Level

    Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks

    Change from baseline in fasting glucose level

  7. Change in HbA1c Level

    Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks

    Change from baseline in HbA1c level

  8. Change in Insulin Level

    Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks

    Change from baseline in insulin level

  9. Change in Total Cholesterol Level

    Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks

    Change from baseline in serum total cholesterol level

  10. Change in Triglyceride(TG) Level

    Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks

    Change from baseline in serum TG level

  11. Change in HDL Cholesterol Level

    Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks

    Change from baseline in serum high-density lipoprotein (HDL) cholesterol level

  12. Change in LDL Cholesterol Level

    Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks

    Change from baseline in serum LDL(low-density lipoprotein) cholesterol level

  13. Change in hsCRP Level

    Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks

    Change from baseline in high-sensitivity C-reactive protein level

  14. Change in Body Composition

    Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks

    Change in body composition measured by BIA

  15. Change in the Number of Metabolic Syndrome Components

    Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks

    Change in the number of metabolic syndrome components.

  16. Change in Framingham Risk Score

    Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks

    Change in Framingham Risk Score. Higher scores indicate a higher estimated risk of cardiovascular disease.

  17. Change in PREVENT Risk Score

    Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks

    Change in Predicting Risk of Cardiovascular Disease EVENTs (PREVENT) risk score. Higher scores indicate a higher estimated risk of cardiovascular disease.

  18. Change in SCORE2

    Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks

    Change in in Systematic COronary Risk Evaluation 2 (SCORE2). Higher scores indicate a higher estimated risk of cardiovascular disease.

  19. Change in coronary artery calcium score

    Time frame: Baseline and 156 weeks

    Change in coronary artery calcium score (CACS) measured by coronary computed tomography angiography The coronary artery calcium score is measured using the Agatston method; the minimum value is 0, there is no fixed maximum value, and higher scores indicate greater coronary artery calcification.

  20. Change in Coronary Artery Stenosis

    Time frame: Baseline and 156 weeks

    Change in coronary artery stenosis measured by coronary computed tomography angiography

Study contacts

Contact information is provided by the study sponsor or research team.

Jiyoon Lee

CONTACT

[email protected]

82-10-4850-4828

Soo Lim

CONTACT

[email protected]

82-10-9766-2706

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

Comparison of Efficacy and Safety Between Aspirin and Cilostazol on Cardiovascular Event in Patients at High Risk of Cardiovascular Disease, Randomization.

Acronym: Cilo-Asa

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 22, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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