Rivaroxaban in Patients With Atrial Fibrillation Undergoing PCI (RIVA-PCI)

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome; Percutaneous Coronary Intervention; Non-valvular Atrial Fibrillation; Antithrombotic Therapy

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.

• Study Type: Observational
• Enrollment (Actual): 1632

Contacts and Locations

Study Locations

• Germany
  • Bad Nauheim, Germany, 61231
    • Kerckhoff-Klinik
  • Bad Segeberg, Germany, 23795
    • Segeberger Kliniken
  • Bitterfeld-Wolfen, Germany, 06749
    • Gesundheitszentrum Bitterfeld-Wolfen
  • Bremen, Germany, 28277
    • Klinikum Links der Weser
  • Buchholz, Germany, 21244
    • Krankenhaus Buchholz
  • Coburg, Germany, 96450
    • Klinikum Coburg
  • Heilbronn, Germany, 74078
    • SLK-Kliniken Heilbronn
  • Ludwigshafen, Germany, 67063
    • Städtisches Klinikum Ludwigshafen
  • Mannheim, Germany, 68167
    • Universitätsklinikum Mannheim
  • Munich, Germany, 81377
    • Klinikum der Universität München , Campus Großhadern
  • Siegen, Germany, 57076
    • Kreisklinikum Siegen
  • Stuttgart, Germany, 70376
    • Robert-Bosch-Krankenhaus
  • Villingen-Schwenningen, Germany, 78052
    • Schwarzwald-Baar Klinikum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Consecutive, unselected recruitment of patients fulfilling the eligibility criteria.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antithrombotic combination therapies (treatment patterns) in patients with non-valvular AF undergoing PCI	Real-life data on the prescription of antithrombotic medication for patients with atrial fibrillation after PCI	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of antithrombotic medication during long-term follow-up	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)	14 months
Adverse Events during baseline and follow-up	Documentation of Adverse Events during baseline hospital stay (by treating physician) and during long-term follow-up (patient-reported)	32 months
Treatment adherence of patients	Patient-reported information on their adherence to the antithrombotic treatment strategy	14 months

Collaborators and Investigators

• Sponsor: IHF GmbH - Institut für Herzinfarktforschung
• Collaborators: Bayer
• Investigators: Principal Investigator: Uwe Zeymer, Prof. Dr., Institut für Herzinfarktforschung (Institute for Cardiac Research)

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): June 24, 2021

Study Registration Dates

• First Submitted: October 10, 2017
• First Submitted That Met QC Criteria: October 16, 2017
• First Posted (Actual): October 20, 2017

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Rivaroxaban; PCI; NOAC; ACS; Non-valvular AF
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Acute Coronary Syndrome
• Other Study ID Numbers: RIVA-PCI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

IPD Plan Description

An intermediate report summarizing the baseline data will be provided to Bayer (financial support).

A final report summarizing baseline and follow-up data will be provided to ethical committees in Germany, to governmental authority, and to Bayer.

Participating clinics will receive benchmarking reports (comparison of their own data with those of all other sites).

Data will be made accessible to participating investigators for publication in journals and on conferences.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No