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临床试验/NCT02484924
NCT02484924已完成不适用

The Risk of Major Bleeding With Novel Anti-platelets: A Comparison of Ticagrelor With Clopidogrel in a Real World Population of 5000 Patients Treated for Acute Coronary Syndrome

Liverpool University Hospitals NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 5,225 人开始时间: 2010年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
5,225
试验地点
1
主要终点
The incidence of major bleeding defined by both BARC (3-5) and PLATO definitions

研究概览

简要总结

A retrospective real world analysis of bleeding events with ticagrelor compared to clopidogrel in ACS patients.

详细描述

Major bleeding after myocardial infarction portends a poor outcome. A balance is required between potency of platelet inhibition and risk of bleeding. Ticagrelor provides faster and more effective platelet inhibition than Clopidogrel. In the PLATO trial Ticagrelor reduced the incidence of cardiovascular death, myocardial infarction and stroke compared to Clopidogrel after ACS (acute coronary syndrome). Although there was no difference in overall bleeding there was more non-CABG related major bleeding with Ticagrelor. It has since been recommended, in addition to aspirin, in treatment of moderate-high risk ACS by both ESC (European Society of Cardiology) and NICE (National Institute for Clinical Excellence). There has been widespread adoption as first line therapy in UK hospitals. There remains potential concern about bleeding in a "real world" population compromising more high risk patients; particularly more elderly and female, than those in PLATO. The investigators intend to perform a large "real world" comparison of bleeding risk with Ticagrelor compared to Clopidogrel in a UK ACS population. The investigators plan an observational cohort study of patients presenting with ACS at 5 district general hospitals in Merseyside and Cheshire. The investigators will collect data retrospectively on 2500 patients treated with Clopidogrel prior to the guideline change and 2500 treated with Ticagrelor thereafter. The primary end point will be incidence of BARC 3-5 (Bleeding Academic Research Consortium) and PLATO major bleeding.

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

  • Patient commenced on clopidogrel for ACS prior to change of ACS guidelines, or tiacgrelor for same indication afterwards.

排除标准

  • Patient already taking the drug in question (clopidogrel or ticagrelor) prior to the ACS event
  • Patients under 18 years of age
  • Patients in whom the drug is stopped during the same hospital admission due to clinical judgement dictating that it is no longer indicated (this does not apply to patients in whom a bleeding event is the precipitant for stopping the drug)

研究组 & 干预措施

Ticagrelor Group

Those patients treated with ticagrelor for ACS (after new guideline implementation)

干预措施: Ticagrelor (Drug)

结局指标

主要结局

The incidence of major bleeding defined by both BARC (3-5) and PLATO definitions

时间窗: 12 months from treatment starting

bleeding event

次要结局

  • Incidence of minor bleeding as defined by BARC and PLATO(12 months from treatment starting)
  • Incidence of intracranial bleeding(12 months from treatment starting)
  • Rate of major adverse cardiovascular events; myocardial infarction, stroke and cardiovascular death(12 months from treatment starting)
  • Mortality(12 months from treatment starting)
  • Incidence of gastrointestinal bleeding(12 months from treatment starting)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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