A Randomized, Placebo Controlled, Double-blind, Phase 4 Study to Evaluate Efficacy and Safety of Triple Anti-platelet Therapy Compared With Dual Antiplatelet Therapy in Patients Treated With Drug Eluting Stent for Coronary Artery Disease
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 402
- 试验地点
- 12
- 主要终点
- Major Adverse Cardiac and Cerebrovascular Ischemic Events (MACCE)
研究概览
简要总结
The DECREASE-PCI trial is a prospective, randomized, placebo controlled, double-blind, phase 4 study to evaluate efficacy and safety of triple anti-platelet therapy compared with dual antiplatelet therapy in patients treated with DES for Coronary Artery Disease.
The primary objective of this study is to compare the safety and efficacy of triple antiplatelet therapy versus dual (standard) antiplatelet therapy in patients treated with drug-eluting stent (DES) implantation for the treatment of coronary artery disease.
详细描述
Use of drug-eluting stent (DES) has reduced the incidence of restenosis rate and the need for repeat revascularization compared to using bare metal stents (BMS). Therefore, DES implantation has been default strategy in the treatment of coronary artery disease. However, despite use of DES, the restenosis, subsequent repeat revascularization, and associated cardiac events (stent thrombosis, myocardial infarction) remain significant clinical problem in routine practice, especially complex lesion subsets.
2110 patients who received successful dug eluting stent implantation will be enrolled at 21 centers in Korea. Patients meeting inclusion criteria without any exclusion criteria and agree to participate in this trial will be randomized 1:1 to a) triple therapy (Aspirin+Clopidogrel +Cilostazol) or b) dual therapy group (Aspirin+ Clopidogrel +Placebo). All patients will be blindly assigned to cilostazol 100mg (1tablet bid) or matching placebo (1tablet bid) as 1:1 ratio and are prescribed for 1 year.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with angina and documented ischemia or patients with documented silent ischemia
- •Patients who are eligible and has been successfully applied for DES implantation
- •Age >18 years
- •Signed written informed consent form prior to study entry
- •Angiographic
- •De novo lesion or restenotic lesions
- •Percent diameter stenosis ≥50%
- •Reference vessel size 2.5 mm by visual estimation
排除标准
- •History of bleeding diathesis or coagulopathy (e.g. current use of NSAIDs, Upper GI bleeding during the recent 6 months)
- •Pregnancy or lactation (women who have child-bearing potential)
- •Known hypersensitivity or contra-indication to contrast agent, heparin, eluted-drug of stent
- •Limited life-expectancy (less than 1 year) due to combined serious disease
- •Characteristics of lesion 1)Left main disease 2)Graft vessels
- •Hematological disease (Neutropenia <3000/mm3, Thrombocytopenia <100,000/mm3)
- •Hepatic dysfunction, liver enzyme (ALT and AST) elevation 3 times normal
- •Renal dysfunction, creatinine 2.0mg/dL
- •Contraindication to aspirin, clopidogrel or cilostazol
- •Stroke (ischemic or hemorrhagic) or transient ischemic attack (TIA) within 6 months.
- •Planned major surgery within the next 6 months with the need to discontinue antiplatelet therapy
研究组 & 干预措施
cilostazol
cilostazol 100mg
干预措施: Cilostazol (Drug)
dual therapy group
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Major Adverse Cardiac and Cerebrovascular Ischemic Events (MACCE)
时间窗: At 1-year time point after PCI
composite of any death, myocardial infarction, ischemic stroke, target vessel revascularization
次要结局
- Major Adverse Cardiac Events (MACE)(At 1-year time point and yearly up to 3 years after PCI)
研究者
Seung-Jung Park
M.D., Ph.D.,Professor of Medicine Asan Medical Center, University of Ulsan, College of Medicine
CardioVascular Research Foundation, Korea