NCT07719894招募中4 期
Comparison of Efficacy and Safety Between Aspirin and Cilostazol on Cardiovascular Event in Patients at High Risk of Cardiovascular Disease, Randomization.
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE)
时间窗: 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
次要结局
- Incidence of Three-Point Major Adverse Cardiovascular Events(Up to 156 weeks)
- Incidence of Heart Failure Events(Up to 156 weeks)
- Incidence of Peripheral Vascular Events(Up to 156 weeks)
- Change in CK-MB Level(Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks)
- Change in Troponin-I Level(Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks)
- Change in Fasting Glucose Level(Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks)
- Change in HbA1c Level(Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks)
- Change in Insulin Level(Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks)
- Change in Total Cholesterol Level(Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks)
- Change in Triglyceride(TG) Level(Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks)
- Change in HDL Cholesterol Level(Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks)
- Change in LDL Cholesterol Level(Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks)
- Change in hsCRP Level(Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks)
- Change in Body Composition(Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks)
- Change in the Number of Metabolic Syndrome Components(Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks)
- Change in Framingham Risk Score(Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks)
- Change in PREVENT Risk Score(Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks)
- Change in SCORE2(Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks)
- Change in coronary artery calcium score(Baseline and 156 weeks)
- Change in Coronary Artery Stenosis(Baseline and 156 weeks)
研究者
Soo Lim
Professor
Seoul National University Bundang Hospital
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
How do dapagliflozin and vildagliptin differ in protecting the heart and ensuring safety when added to the regular treatment of patients who have both type 2 diabetes and high blood pressure?CTRI/2025/10/096654BPS GMC For Women90
尚未招募
不适用
Comparing How Atorvastatin and Rosuvastatin Affect Bone Health in People with Type 2 DiabetesCTRI/2025/08/093537AIIMS Mangalagiri92
尚未招募
不适用
A study on how type 2 diabetes affects the heart and daily lifeCTRI/2025/07/091566NGSM Institute of Pharmaceutical Sciences243
尚未招募
3 期
Efficacy Evaluation of Glimepiride in Patients With Type 2 Diabetes Mellitus and Chronic Heart Failure With Reduced Ejection Fraction.NCT07288749Tongji Hospital1,484
尚未招募
不适用
Cardiovascular Risk in T2DM With MAFLD: A Cohort StudyType 2 Diabetes (T2DM)Metabolic Dysfunction-Associated Steatotic Liver DiseaseNCT07706010The Affiliated Hospital of Hangzhou Normal University7,000