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临床试验/NCT03012906
NCT03012906Unknown不适用

Prospective Multicenter Registry of the Combination of Antiplatelet Agents and Anticoagulant in Atrial Fibrillation Patients With a CHA2DS2VASc Score >1 Undergoing Percutaneous Coronary Interventions

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
500
试验地点
1
主要终点
Number of deaths

研究概览

简要总结

Patients undergoing percutaneous coronary intervention (PCI) with stent implantation and requiring chronic anticoagulation for atrial fibrillation (AF) with a CHA2DS2-VASc >1 are required to receive triple antithrombotic therapy . This triple therapy includes dual antiplatelet therapy with clopidogrel and aspirin in combination with an oral anticoagulant with either a vitamin K antagonist (VKA) or an oral anticoagulant (NOAC).

Recently NOAC, inhibiting the IIa (dabigatran) or Xa (rivaroxaban and apixaban) in the coagulation cascade have demonstrated non inferiority compared to VKA to prevent thrombo-embolic events in non-valvular AF for patients with a CHA2DS2-VASc >1 . Interestingly, NOAC are associated with a reduced fatal bleeding rate compared to VKA. Overall they seem to result in a lower bleeding rate compared to VKA in association with antiplatelet agents.

Recently European guidelines regarding patients requiring chronic anticoagulant therapy and undergoing coronary stent implantation have been updated. However they are based on an expert consensus because of the scarce data available.

These guidelines advocate the combination of dual antiplatelet therapy with clopidogrel and aspirin in combination with the lower dose of OAC or VKA with a target INR between 2 and 2.5 . The triple therapy should be prescribed for 1 to 6 months depending on the bleeding and thrombotic risk and the clinical setting. In patients with high bleeding risk the guidelines suggest that a sole antiplatelet agent could be used in addition to anticoagulation following the WOEST study . In the recently published ESC guidelines on the management of atrial fibrillation, despite the lack of new data, the expert advocate triple therapy followed by dual antiplatelet therapy in most patients for 12 months.

The recently published PIONEER study reinforced the possibility of the use of rivaroxaban in these patients. In this trial including ACS and not ACS patients undergoing PCI rivaroxaban 15 mg in addition to a P2Y12 ADP receptor antagonist was associated with less clinically relevant bleeding compared to triple therapy with VKA- aspirin and clopidogrel and similar efficacy .

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

入选标准

  • age over 18 years old
  • signed informed consent
  • requiring PCI (with stent placement) with subsequent need for antiplatelet therapy
  • FA requiring chronic anticoagulation (CHA2DS2-VASc >1, except women with a score =1).

排除标准

  • pregnancy or lactation
  • age <18 or not able to give an informed consent
  • no informed consent
  • no health insurance
  • contra indication to antiplatelet therapy
  • intra cardiac thrombus
  • active bleeding Known bleeding diathesis (i.e. history of ICH, GI bleeding)
  • severe kidney failure (eGFR < 30 mL/min/1.73 m²)
  • severe hepatic failure (Child-Pugh class B or C)
  • contra indication to OAC or VKA
  • hypertrophic myocardiopathy
  • valvular prosthesis
  • history of peptic ulcer

结局指标

主要结局

Number of deaths

时间窗: 2 years

Number of myocardial infarctions

时间窗: 2 years

Number of strokes

时间窗: 2 years

次要结局

  • The prevalence of bleeding events(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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