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Completed

NCT Number: NCT03315650

Rivaroxaban in Patients With Atrial Fibrillation Undergoing PCI

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kerckhoff-Klinik, Bad Nauheim, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

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

    Time frame: 18 months

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

Secondary outcomes

  1. Evaluation of antithrombotic medication during long-term follow-up

    Time frame: 14 months

    Patients receiving Rivaroxaban after index PCI are asked for their further antithrombotic medication in two telephone interviews (3 months and 14 months after index PCI)

  2. Adverse Events during baseline and follow-up

    Time frame: 32 months

    Documentation of Adverse Events during baseline hospital stay (by treating physician) and during long-term follow-up (patient-reported)

  3. Treatment adherence of patients

    Time frame: 14 months

    Patient-reported information on their adherence to the antithrombotic treatment strategy

Sponsors and collaborators

Lead sponsor

IHF GmbH - Institut für Herzinfarktforschung

Other

Collaborators

  • Bayer

Registry information

Official study title

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

Acronym: RIVA-PCI

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Oct 20, 2017
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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