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临床试验/NCT05746416
NCT05746416已完成不适用

Xience Registry Study for the Impact of Early Use of Low-Dose Ticagrelor-Based Dual Antiplatelet Therapy to Clinical Outcomes in Patient Undergoing Percutaneous Coronary Interventions for Complex Lesions

Hanyang University Seoul Hospital1 个研究点 分布在 1 个国家目标入组 977 人开始时间: 2019年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
977
试验地点
1
主要终点
A major adverse cardiac and cerebrovascular event (MACE)

研究概览

简要总结

The goal of this multicenter prospective clinical cohort study is to investigate the impact of early use of low-dose Ticagrelor-based dual antiplatelet agent therapy (TDAPT) (ticagrelor 120mg daily; l-TDAPT) as compared to standard-dose TDAPT (ticagrelor 180mg daily; s-TDAPT) in outcomes of percutaneous coronary intervention (PCI).

The main question it aims to answer are:

Given the low ischemic risk and high bleeding tendency in Asians, the low dose TDAPT may provide better net clinical benefits of ischemic and bleeding events than the standard dose TDAPT.

详细描述

Participants were administrated with 300mg of Aspirin and 180mg of ticagrelor orally before they underwent index PCI, and were prescribed with s-TDAPT from the next day after index PCI at least for 1 week. The start of l-TDAPT was decided by each attending physician's preference.

Successful PCI was defined as a residual stenosis <30% with Thrombolysis in Myocardial Infarction grade 3 flow after PCI and the absence of death by MI and reintervention for the index coronary lesions during the admission period. Standard definitions of cardiovascular events were used for all clinical events. Myocardial infarction (MI) was defined using the 4th universal definition of MI as previously described. Repeat revascularization (RR) was defined as a new PCI for the target vessels or de-novo coronary lesions. All-cause death was defined as a death from any cause. Cardiovascular death was defined as death from MI, stent thrombosis and ischemic stroke. A major adverse cardiac and cerebrovascular event (MACE) was defined as a composite of cardiovascular death, non-fetal MI, RR, stent thrombosis and ischemic stroke. A bleeding event was defined as the bleeding event equivalent to Bleeding Academic Research Consortium (BARC) classification 2 or higher. A net clinical event (NCE) was defined as a composite of MACEs and bleeding events. Patients were scheduled to follow up to 2 years after index PCI. Clinical follow-up started when a patient discharged from the hospitalization for the index PCI and ended when the patient experienced the any clinical event or reached the end of follow-up. The follow-up visits were scheduled at 1, 3 and 6 months, 1 year and 2 years after discharge.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • 19 years of age or older
  • acute coronary syndrome (ACS) undergoing PCI
  • PCI for complex coronary lesions using everolimus-eluting stents (Xience®, Abbot corp, Chicago, Illinois, US)
  • prescribed with s-TDAPT for more than 3 months

排除标准

  • cardiogenic shock
  • PCI using drug-eluting stents (DES) other than the everolimus-eluting stents
  • those who had conditions requiring a long-term oral anticoagulant therapy
  • those with life expectancy <1 year

结局指标

主要结局

A major adverse cardiac and cerebrovascular event (MACE)

时间窗: at 1 years after discharge

a composite of cardiovascular death, non-fetal MI, RR, stent thrombosis and ischemic stroke.

次要结局

  • bleeding event(at 1 years after discharge)
  • Myocardial infarction(at 1 years after discharge)
  • Repeat revascularization(at 1 years after discharge)
  • A net clinical event (NCE)(at 1 years after discharge)
  • All cause death(at 1 years after discharge)
  • cardiovascular death(at 1 years after discharge)

研究者

发起方
Hanyang University Seoul Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Young-Hyo Lim

professor

Hanyang University Seoul Hospital

研究点 (1)

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