Clinical trial NCT03315650: Rivaroxaban in Patients With Atrial Fibrillation Undergoing PCI
Official title: RIVA-PCI Registry - Prospective Registry of Rivaroxaban in Patients With Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-valvular Atrial Fibrillation
Acute Coronary Syndrome
Percutaneous Coronary Intervention
Antithrombotic Therapy
Keywords: Non-valvular AF
ACS
PCI
NOAC
Rivaroxaban
Lead sponsor: IHF GmbH - Institut für Herzinfarktforschung
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2017-10-20
Enrollment: 1632
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive, unselected recruitment of patients fulfilling the eligibility criteria.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Antithrombotic combination therapies (treatment patterns) in patients with non-valvular AF undergoing PCI
timeFrame: 18 months
Secondary outcomes:
measure: Evaluation of antithrombotic medication during long-term follow-up
timeFrame: 14 months
measure: Adverse Events during baseline and follow-up
timeFrame: 32 months
measure: Treatment adherence of patients
timeFrame: 14 months
Other outcomes:
Locations:
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik
city: Bad Segeberg
country: Germany
facility: Segeberger Kliniken
city: Bitterfeld-Wolfen
country: Germany
facility: Gesundheitszentrum Bitterfeld-Wolfen
city: Bremen
country: Germany
facility: Klinikum Links der Weser
city: Buchholz
country: Germany
facility: Krankenhaus Buchholz
city: Coburg
country: Germany
facility: Klinikum Coburg
city: Heilbronn
country: Germany
facility: SLK-Kliniken Heilbronn
city: Ludwigshafen
country: Germany
facility: Städtisches Klinikum Ludwigshafen
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim
city: Munich
country: Germany
facility: Klinikum der Universität München , Campus Großhadern
city: Siegen
country: Germany
facility: Kreisklinikum Siegen
city: Stuttgart
country: Germany
facility: Robert-Bosch-Krankenhaus
city: Villingen-Schwenningen
country: Germany
facility: Schwarzwald-Baar Klinikum
Study officials:
affiliation: Institut für Herzinfarktforschung (Institute for Cardiac Research)
name: Uwe Zeymer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: