NCT06577896招募中不适用
Safety and Efficacy of 1-month Dual Antiplatelet Therapy in High Bleeding and Ischemic Risk Elderly Patients With Coronary Artery Disease After Implantation of Zotarolimus-eluting Coronary Stent System (Onyx Family, Medtronic, Minneapolis, MN); A Multicenter, Prospective, Observational Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- MACCE at 12 months after coronary artery intervention
研究概览
简要总结
Observation of the safety and efficacy of 1-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention using Onyx family stents in elderly patients aged 75 years or older
详细描述
For elderly patients aged 75 years or older undergoing percutaneous coronary intervention with Onyx family drug-eluting stents, observe the safety and efficacy of transitioning from dual antiplatelet therapy to single therapy for one year after one month of dual antiplatelet therapy
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 75 or more.
- •Eligible for interventional procedures.
- •Evidence of myocardial ischemia or coronary artery stenosis ≥ 50%.
- •Able to take antiplatelets for at least 1 months after the procedure.
- •Patients who underwent coronary artery procedures with ZES (Medtronic, Minneapolis, MN, Onyx™ family) stent.
排除标准
- •The patient has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, zotarolimus, and contrast media (patients with documented sensitivity to contrast media which can be effectively premedicated with steroids and diphenhydramine [eg, rash] may be enrolled. Those with true anaphylaxis to prior contrast media, however, should not be enrolled).
- •Patients with active pathologic bleeding.
- •Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
- •History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia).
- •Noncardiac comorbid conditions are present with life expectancy <1 year or that may result in protocol noncompliance (per site investigator's medical judgment).
- •Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
结局指标
主要结局
MACCE at 12 months after coronary artery intervention
时间窗: 1 year after the procedure
MACCE defined as a composite of all-cause mortality, MI, and cerebrovascular events at 12 months after the index procedure
次要结局
- safety of procedures(1 year after the procedure)
研究者
Min Ku Chon
Associate Professor
Pusan National University Yangsan Hospital
研究点 (1)
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