NCT00776828已完成4 期
Influence of CILostazol-based Triple Anti-platelet Therapy ON Ischemic Complication After Drug-eluting stenT Implantation
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 960
- 试验地点
- 1
- 主要终点
- Composite of adverse cardiovascular outcomes
研究概览
简要总结
Objectives :
- To evaluate the influence of concomitant use of cilostazol with aspirin and clopidogrel on the composite cardiovascular adverse outcomes (cardiac death, myocardial infarction, nonhemorrhagic stroke, target lesion revascularization) after drug-eluting stent implantation
Study Design : Prospective, open label, two arm, randomized multicenter trial to test the superiority of cilostazol group compared with the control group. Patients will be randomized according to the use of cilostazol
Patient Enrollment: 960 patients enrolled at 5 centers in Korea
Patient Follow-up : Clinical follow-up will occur at 1, 3 and 6 months. Angiographic follow-up will be recommended to all patient at 6 months after index procedure.
Primary Endpoint
- Composite of adverse cardiovascular/cerebrovascular outcomes (cardiac death, myocardial infarction, nonhemorrhagic stroke, target lesion revascularization) within 6 months
Secondary Endpoint
- All cause of death, stent thrombosis, and each component of primary endpoint at six months
- PRU level measured at discharge after the index procedure and after six months
Safety Endpoint
- Bleeding complications according to TIMI criteria
- The incidence of drug discontinuation
- Heart rate
详细描述
Stratified randomization by statin type (rosuvastatin or atorvastatin) and the center was performed
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be at leat 18 years of age
- •Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of cilostazol and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
- •Subject must have significant coronary artery stenosis (>50% by visual estimate)
- •Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, recent infarction, silent ischemia, positive functional study or reversible changes in the electrocardiogram (ECG) consistent with ischemia. In subjects with coronary artery stenosis>75%, evidence of myocardial ischemia does not have to be documented.
- •Coronary lesions must be amenable for percutaneous coronary revascularization with drug eluting stents.
排除标准
- •Subject who undergoes primary percutaneous coronary intervention due to acute ST elevation myocardial infarction
- •Subject who has contraindication or allergy to anti-platelet agents (aspirin, clopidogrel or cilostazol)
- •Subject who has thrombocytopenia (<120,000/uL)
- •Subject who has liver cirrhosis (Child class B or C)
- •Subject who is on the anticoagulation therapy
- •Subject who has severe congestive heart failure (left ventricular ejection fraction <30%)
研究组 & 干预措施
TAT
Active Comparator
triple antiplatelet therapy : aspirin, clopidogrel and cilostazol
干预措施: cilostazol (Drug)
DAT
Placebo Comparator
dual antiplatelet therapy : aspirin, clopidogrel
干预措施: cilostazol (Drug)
结局指标
主要结局
Composite of adverse cardiovascular outcomes
时间窗: six months
composite of cardiac death, myocardial infarction, ischemic stroke and target lesion revascularization
次要结局
- all cause of death(six months)
- stent thrombosis(six months)
- each component of primary endpoint(six months)
- PRU level(six months after the index procedure)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Diabetic Artery Obstruction: is it Possible to Reduce Ischemic Events With Cilostazol?Ischemic StrokePeripheral Artery DiseaseDiabetes Mellitus, Type 2NCT02983214University of Ioannina826
已完成
不适用
Comparison of cilostazol-based triple antiplatelet therapy versus dual antiplatelet therapy for outcomes of below-the knee endovascular intervention in patients with critical limb ischemia (TAP CLI study)Diseases of the circulatory systemKCT0002873Yonsei University Health System, Severance Hospital175
已完成
4 期
Triple Versus Dual Antiplatelet Therapy in Patients Undergoing Coronary Stent ImplantationAcute Coronary SyndromeNCT00404716Shenyang Northern Hospital
Unknown
4 期
Comparison of Cilostazol-based Triple Antiplatelet Therapy Versus Dual Antiplatelet Therapy for Outcomes of below-the Knee Endovascular Intervention in Patients With Critical Limb Ischemia (TAP CLI Study)Critical Limb IschemiaNCT02829151Yonsei University390
Unknown
3 期
Comparison of Platelet Inhibition With Adjunctive Cilostazol Versus High Maintenance-Dose Clopidogrel According to Hepatic Cytochrome 2C19 Allele (CYP2C19) PolymorphismCoronary Artery StenosisMaximal Platelet AggregationLate Platelet AggregationHigh Post-Treatment Platelet ReactivityNCT00891670Gyeongsang National University Hospital80