NCT05559918招募中不适用
Dual-antiplatelet Therapy Strategies for Elective PCI in a Real-world Setting
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)2 个研究点 分布在 1 个国家目标入组 1,462 人开始时间: 2022年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,462
- 试验地点
- 2
- 主要终点
- Net adverse clinical events (NACE)
研究概览
简要总结
To assess the safety and efficacy of in-laboratory clopidogrel loading dose administration before ad-hoc PCI versus clopidogrel preloading treatment in patients planned for diagnostic angiography with optional ad-hoc PCI.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult men and women aged at least 18 years
- •Scheduled for diagnostic CAG due to suspected obstructive coronary artery disease
排除标准
- •Presence of contra-indications for the use of clopidogrel (hypersensitivity or known allergy to clopidogrel, severe liver insufficiency, resent or active pathological bleeding, patients known to be poor CYP2C19 metabolizers, patients using pharmacological CYP2C19 inhibitors and inducers)
- •Patients using clopidogrel for other reasons than the scheduled diagnostic CAG (e.g. due to previous stroke)
- •Patients using P2Y12 inhibitors other than clopidogrel (e.g. prasugrel, ticagrelor, cangrelor)
- •Patients using VKA (e.g. acenocoumarol, fenprocoumon)
- •Patients using DOAC/NOAC (e.g. apixaban, dabigatran, edoxaban, rivaroxaban)
- •Inability to give informed consent (e.g., language barrier)
- •Patients who have a documented mentioning of previous denial to any trial participation in the electronic patient dossier
结局指标
主要结局
Net adverse clinical events (NACE)
时间窗: 30 days
The incidence rate of NACE (the composite of the clinical events all-cause death, myocardial infarction, definite/probable stent thrombosis, stroke and BARC type 2, -3 or -5 bleeding) wil be compared between groups at 30 days
次要结局
- Bleeding (classified as BARC type 2, -3 and -5 bleeding)(In-hospital, at 30 days)
- Stroke(In-hospital, at 30 days)
- Patient oriented clinical events (POCE)(In-hospital, at 30 days)
- Myocardial infarction(In-hospital, at 30 days)
- Stent thrombosis (definite/probable)(In-hospital, at 30 days)
- All-cause mortality(In-hospital, at 30 days)
- Repeat revascularisation(In-hospital, at 30 days)
研究者
Ronak Delewi
Principal Investigator Dr. R Delewi
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
研究点 (2)
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