Rivaroxaban in Patients With Atrial Fibrillation Undergoing PCI

NCT ID: NCT03315650

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1632 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2021-06-24

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.

Conditions

Non-valvular Atrial Fibrillation; Acute Coronary Syndrome; Percutaneous Coronary Intervention; Antithrombotic Therapy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

IHF GmbH - Institut für Herzinfarktforschung

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Uwe Zeymer, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Institut für Herzinfarktforschung (Institute for Cardiac Research)

Locations

Kerckhoff-Klinik

Bad Nauheim, , Germany

Segeberger Kliniken

Bad Segeberg, , Germany

Gesundheitszentrum Bitterfeld-Wolfen

Bitterfeld-Wolfen, , Germany

Klinikum Links der Weser

Bremen, , Germany

Krankenhaus Buchholz

Buchholz, , Germany

Klinikum Coburg

Coburg, , Germany

SLK-Kliniken Heilbronn

Heilbronn, , Germany

Städtisches Klinikum Ludwigshafen

Ludwigshafen, , Germany

Universitätsklinikum Mannheim

Mannheim, , Germany

Klinikum der Universität München , Campus Großhadern

Munich, , Germany

Kreisklinikum Siegen

Siegen, , Germany

Robert-Bosch-Krankenhaus

Stuttgart, , Germany

Schwarzwald-Baar Klinikum

Villingen-Schwenningen, , Germany

Countries

Germany

References

Zeymer U, Toelg R, Wienbergen H, Hobbach HP, Cuneo A, Bekeredjian R, Ritter O, Hailer B, Hertting K, Hennersdorf M, Scholtz W, Lanzer P, Mudra H, Schwefer M, Schwimmbeck PL, Liebetrau C, Thiele H, Claas C, Riemer T, Zahn R. Rivaroxaban in Patients With Atrial Fibrillation Who Underwent Percutaneous Coronary Intervention in Clinical Practice. Am J Cardiol. 2023 Feb 15;189:31-37. doi: 10.1016/j.amjcard.2022.11.009. Epub 2022 Dec 6.

Reference Type: DERIVED

PMID: 36493580 (View on PubMed)

Other Identifiers

RIVA-PCI

Identifier Type: -

Identifier Source: org_study_id