Drug-Coated Stent Versus Drug-Eluting Stent for One-month Dual-antiplatelet Therapy in Patients With Acute Coronary Syndrome: ONE-PASS Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,520
- 试验地点
- 2
- 主要终点
- Patient-Oriented Composite Endpoint (POCE)
研究概览
简要总结
To test whether the polymer-free drug-coated stent (DCS) BioFreedom is noninferior to the biodegradable polymer drug-eluting stent (DES) Ultimaster in terms of 1-year patient-oriented composite endpoint (POCE, composite of all-cause mortality, any MI, or any revascularization) in a setting of 1-month dual-antiplatelet therapy (DAPT) strategy (1-month DAPT followed ticagrelor monotherapy) after acute coronary syndrome.
详细描述
This trial is an open-label, randomized, multi-center study. Patients with ACS requiring percutaneous coronary intervention will be randomized with a 1:1 ratio either of DCS group or DES group. After the index procedure, DAPT (100 mg aspirin qd and 90 mg ticagrelor bid) will be given for 1 month. After this, ticagrelor monotherapy will be maintained for 11 months. Clinical events will be evaluated within 12 months after randomization.
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
- Single (Outcomes Assessor)
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
- •Age ≥19 years
- •All subjects who are acceptable candidates for treatment with a drug-coated stent or drug-eluting stent because of acute coronary syndrome
- •Provision of informed consent
排除标准
- •Current or potential pregnancy
- •Need of oral anticoagulation therapy
- •Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
结局指标
主要结局
Patient-Oriented Composite Endpoint (POCE)
时间窗: At 1 year after randomization
The composite of all-cause death, MI, or any revascularization
次要结局
- Stent thrombosis (definite or probable)(At 1 year after randomization)
- Target-vessel revascularization(At 1 year after randomization)
- Device-Oriented Composite Endpoint (DOCE)(At 1 year after randomization)
- Myocardial infarction(At 1 year after randomization)
- All-cause death(At 1 year after randomization)
- Cardiovascular death(At 1 year after randomization)
- Non-target vessel revascularization(At 1 year after randomization)
- Target-lesion revascularization(At 1 year after randomization)
- BARC type 2-5 bleeding(At 1 year after randomization)
- Stroke(At 1 year after randomization)
- Any revascularization(At 1 year after randomization)
- BARC type 3-5 bleeding(At 1 year after randomization)
研究者
Chul-Min Ahn
Professor, Principal Investigator
Yonsei University