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Recruiting NCT07719894

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

Phase IV Interventional Type 2 Diabetes Mellitus (T2DM) Atherosclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cilostazol, Aspirin.
Who it may be relevant to
Registry conditions: Type 2 Diabetes Mellitus (T2DM), Atherosclerosis. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Cilostazol
    Drug: Cilostazol Other Name: Pletaal SR Capsule
  • Drug Aspirin
    Drug: AspirinOther Name: ASA

Primary outcome measures

  • Incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) [Time frame: Up to 156 weeks]
Secondary outcome measures (12)
  • Incidence of Three-Point Major Adverse Cardiovascular Events [Time frame: Up to 156 weeks]
  • Incidence of Heart Failure Events [Time frame: Up to 156 weeks]
  • Incidence of Peripheral Vascular Events [Time frame: Up to 156 weeks]
  • Change in CK-MB Level [Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks]
  • Change in Troponin-I Level [Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks]
  • Change in Fasting Glucose Level [Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks]
  • Change in HbA1c Level [Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks]
  • Change in Insulin Level [Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks]
  • Change in Total Cholesterol Level [Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks]
  • Change in Triglyceride(TG) Level [Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks]
  • Change in HDL Cholesterol Level [Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks]
  • Change in LDL Cholesterol Level [Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Seoul National University Bundang Hospital — Seongnam-si

Identifiers

NCT: NCT07719894 · B-2509-995-002 · B-2509-995-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗