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临床试验/NCT03315650
NCT03315650已完成不适用

RIVA-PCI Registry - Prospective Registry of Rivaroxaban in Patients With Atrial Fibrillation

IHF GmbH - Institut für Herzinfarktforschung13 个研究点 分布在 1 个国家目标入组 1,632 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,632
试验地点
13
主要终点
Antithrombotic combination therapies (treatment patterns) in patients with non-valvular AF undergoing PCI

研究概览

简要总结

This study evaluates the antithrombotic therapy in patients suffering from atrial fibrillation after stent implantation in Germany. Patients prescribed with the novel oral anticoagulant Rivaroxaban will be followed up over 14 months for their adherence to the medication schedule and for complications that occurred after index PCI.

详细描述

Patients suffering from non-valvular atrial fibrillation and presenting with an acute coronary syndrome require special attention with regard to antithrombotic therapy. Current guidelines recommend use of oral anticoagulation for almost all of these patients, the optimal antithrombotic strategy, however, has still to be defined. As with the use of any antithrombotic drug, clinicians need to balance the risks of ischemic stroke and thromboembolism, recurrent cardiac ischemia and/or stent thrombosis, and bleeding and haemorrhagic stroke.

A recently published randomized clinical trial (PIONEER AF) compared the combination of a novel oral anticoagulant (NOAC; Rivaroxaban) plus dual anti-platelet therapy (DAPT) with standard therapy consisting of vitamine K inhibitor plus DAPT. Patients treated with Rivaroxaban showed less incidence of bleedings, whereas ischemic complications, death or stroke were equal in the groups compared.

The RIVA-PCI Registry aims at providing an overview of the current antithrombotic treatment regimen in Germany in real life. Moreover, for patients receiving Rivaroxaban as part of their medication follow-up data with regard to their adherence to antithrombotic medication as well as complications over an interval of 14 months after index procedure will be evaluated.

研究设计

研究类型
Observational
观察模型
Case Only
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 ≥18 years and capable of giving written informed consent
  • Known or newly diagnosed non-valvular atrial fibrillation
  • PCI with stent implantation during index hospital stay
  • Written informed consent for participation in observational study (incl. telephone follow-up)
  • Not simultaneously participating in any randomized trial

排除标准

  • 未提供

结局指标

主要结局

Antithrombotic combination therapies (treatment patterns) in patients with non-valvular AF undergoing PCI

时间窗: 18 months

Real-life data on the prescription of antithrombotic medication for patients with atrial fibrillation after PCI

次要结局

  • Evaluation of antithrombotic medication during long-term follow-up(14 months)
  • Adverse Events during baseline and follow-up(32 months)
  • Treatment adherence of patients(14 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (13)

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