适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Isala
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- NACE
研究概览
简要总结
Cangrelor is a fast and directly acting platelet aggregation inhibitor. It is potentially indicated for several types of patients who are undergoing PCI. A nationwide cangrelor registry has up until now not been performed and with the introduction of cangrelor in the Netherlands its efficacy and safety will be determined.
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 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •One of the following criteria:
- •Patients naïve for P2Y12 inhibition undergoing PCI
- •Patients with suboptimal P2Y12 inhibition undergoing PCI (patients who vomited after P2Y12 loading, out of hospital cardiac arrest (OHCA) patients with restoration of spontaneous circulation (ROSC), patients loaded with P2Y12 inhibitors though platelet inhibition still insufficient (<2 hours after oral loading dose)
- •(N)STEMI patients loaded with P2Y12 inhibitors with large thrombus burden (thrombus grade 4 or 5) on initial coronary angiography (CAG) and undergoing primary PCI with expected insufficient P2Y12 inhibition
排除标准
- •Patients on current/chronic treatment with P2Y12 inhibitors
- •Patients (pre) treated with a GPI
- •Patients with recent major bleeding complications or contraindication to dual antiplatelet therapy:
- •hypersensitivity or allergy to and known contra-indication for aspirin, clopidogrel, ticagrelor or cangrelor
- •history of major clinical bleeding or known coagulopathy
- •active bleeding
- •history of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke
- •known severe liver dysfunction
- •Patients that received any organ transplant or are on a waiting list for any organ transplant
- •Patients undergoing dialysis
- •Pregnant or lactating female
- •Patients currently participating in another investigational drug or device study
结局指标
主要结局
NACE
时间窗: 48 hours
The primary efficacy and safety endpoint is 48 hours Net Adverse Clinical Events (NACE), which is a composite endpoint of all-cause death (including cardiac death), recurrent myocardial infarction, target vessel revascularization, stroke, definite or probable stent thrombosis and bleeding (BARC type 2-5).
次要结局
- NACE 30 days(30 days)
- All individual endpoints in-hospital(In-hospital, mostly up to 72 hours.)
- All individual endpoints at 30-days(30 days)
- TIMI 3 flow post PCI based on angiographic results(post-PCI, mostly up to 1 hour)
研究者
A.H. Tavenier
R.S. Hermanides, Principal investigator
Isala
研究点 (1)
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