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临床试验/NCT05505591
NCT05505591Unknown不适用

Multicenter, Observational, Retrospective Cohort Study of Patients at High Risk of Bleeding Undergoing Percutaneous Coronary Intervention and Treated With Intravenous Cangrelor Infusion (ICARUS)

Universita degli Studi di Genova2 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2022年6月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
900
试验地点
2
主要终点
Rate of NACE

研究概览

简要总结

The study will investigate the prevalence of high bleeding risk (HBR) features and will compare the clinical outcomes of HBR and non-HBR patients among those undergoing percutaneous coronary intervention and receiving cangrelor infusion.

详细描述

Cangrelor administration is currently recommended by international guidelines in patients undergoing PCI who are naïve to P2Y12 inhibitors. These recommendations are based on the large Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition (CHAMPION) program, which encompassed three randomized controlled trials (RCTs) enrolling both chronic and acute coronary syndromes. Consistently, the aforementioned studies showed the benefit of cangrelor in terms of ischemic events (mainly driven by a reduction of myocardial infarction - MI - and stent thrombosis - ST) in the face of an increased rate of minor bleeding. However, those RCTs were primarily focused on populations at considerable ischemic risk and with predictably low bleeding proneness, including young patients without bleeding risk features.

In the contemporary practice, however, PCI is increasingly frequent in patients at high risk of bleeding, who are not formally prevented from being administered with cangrelor by international guidelines and possibly necessitate powerful and rapid-onset platelet inhibition while undergoing complex percutaneous revascularization. The present registry was therefore conceived at the scope of collecting data on the use of cangrelor in high bleeding risk (HBR) patients undergoing contemporary PCI. Specifically, it will assess the frequency of HBR patients in a real-world cohort of individuals treated with cangrelor and will compare the clinical outcomes of HBR and non-HBR patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Cangrelor administration during percutaneous coronary intervention for both acute and chronic coronary syndromes

排除标准

  • Cangrelor administration as a bridge to surgery

研究组 & 干预措施

High bleeding risk

Patients treated with cangrelor who met the Academic Research Consortium (ARC) definition of high bleeding risk (HBR)

干预措施: Cangrelor (Drug)

Non-high bleeding risk

Patients treated with cangrelor who did not meet the Academic Research Consortium (ARC) definition of high bleeding risk (HBR)

干预措施: Cangrelor (Drug)

结局指标

主要结局

Rate of NACE

时间窗: 48 hours

A composite of cardiovascular death, myocardial infarction, stroke, definite or probable stent thrombosis and Bleeding Academic Research Consortium 2-5 bleeding

次要结局

  • Rate of cardiovascular death(During hospital stay (up to discharge day), on average 5 days)
  • Rate of ischemic stroke(During hospital stay (up to discharge day), on average 5 days)
  • Rate of blood transfusion(During hospital stay (up to discharge day), on average 5 days)
  • Rate of myocardial infarction (periprocedural)(48 hours)
  • Rate of bleeding Academic Research Consortium (BARC) 3 and 5 bleeding(48 hours)
  • Rate of myocardial infarction(During hospital stay (up to discharge day), on average 5 days)
  • Rate of hemorrhagic stroke(During hospital stay (up to discharge day), on average 5 days)
  • Rate of MACE(During hospital stay (up to discharge day), on average 5 days)
  • Rate of bleeding Academic Research Consortium (BARC) 2,3 and 5 bleeding(48 hours)
  • Rate of definite or probable stent thrombosis(During hospital stay (up to discharge day), on average 5 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Italo Porto

Full Professor of Cardiology

Universita degli Studi di Genova

研究点 (2)

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