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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03315650
Recruitment Status : Recruiting
First Posted : October 20, 2017
Last Update Posted : August 13, 2019
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
IHF GmbH - Institut für Herzinfarktforschung

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.

Condition or disease
Non-valvular Atrial Fibrillation Acute Coronary Syndrome Percutaneous Coronary Intervention 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.


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Study Type : Observational
Estimated Enrollment : 2100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: RIVA-PCI Registry - Prospective Registry of Rivaroxaban in Patients With Atrial Fibrillation
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive, unselected recruitment of patients fulfilling the eligibility criteria.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03315650


Contacts
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Contact: Christoph Claas, Dr. +49 621 503 ext 2868 claas@ihf.de
Contact: Anja von Au, Dr. +49 621 503 ext 2890 vonAu@ihf.de

Locations
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Germany
Kerckhoff-Klinik Recruiting
Bad Nauheim, Germany, 61231
Contact: Christoph Liebetrau, Dr.    +49(0)6032/996 ext 2626    c.liebetrau@kerckhoff-klinik.de   
Principal Investigator: Helge Möllmann, Prof. Dr.         
Segeberger Kliniken Recruiting
Bad Segeberg, Germany, 23795
Contact: Ralph Tölg, PD Dr.    04551/802 ext 4807    ralph.toelg@segebergerkliniken.de   
Gesundheitszentrum Bitterfeld-Wolfen Recruiting
Bitterfeld-Wolfen, Germany, 06749
Contact: Peter Lanzer, PD Dr.    +49(0)3493 31 ext 2393    planzer@gzbiwo.de   
Klinikum Links der Weser Recruiting
Bremen, Germany, 28277
Contact: Harm Wienbergen, Prof. Dr.    0421-879 ext 1366    harm.wienbergen@klinikum-bremen-ldw.de   
Krankenhaus Buchholz Recruiting
Buchholz, Germany, 21244
Contact: Klaus Hertting, Dr.    +49(0)4181-131356    klaus.hertting@krankenhaus-buchholz.de   
Principal Investigator: Klaus Hertting, Dr. med.         
Klinikum Coburg Recruiting
Coburg, Germany, 96450
Contact: Steffen Schnupp, Dr.    +49(0)9561.22 ext 7293    steffen.schnupp@klinikum-coburg.de   
Principal Investigator: Steffen Schnupp, Dr. med.         
SLK-Kliniken Heilbronn Recruiting
Heilbronn, Germany, 74078
Contact: Marcus Hennersdorf, Prpf. Dr.    +49 (0)7131 - 4925002    marcus.hennersdorf@slk-kliniken.de   
Principal Investigator: Marcus Hennersdorf, Prof. Dr.         
Städtisches Klinikum Ludwigshafen Recruiting
Ludwigshafen, Germany, 67063
Contact: Uwe Zeymer, Prof. Dr.         
Universitätsklinikum Mannheim Recruiting
Mannheim, Germany, 68167
Contact: Ibrahim Akin, Prof. Dr.    +49(0)621/383 ext 1492    ibrahim.akin@umm.de   
Klinikum der Universität München , Campus Großhadern Recruiting
Munich, Germany, 81377
Contact: Ralph Hein-Rothweiler, Dr.    +49(0)89 4400 ext 73911    ralph.hein-rothweiler@med.uni-muenchen.de   
Kreisklinikum Siegen Recruiting
Siegen, Germany, 57076
Contact: Hans-Peter Hobbach, Dr.    0271-7051601    h-p.hobbach@KREISKLINIKUM-SIEGEN.de   
Robert-Bosch-Krankenhaus Recruiting
Stuttgart, Germany, 70376
Contact: Raffi Bekeredjian, Prof. Dr.    0711/8101 ext 2968    raffi.bekeredjian@rbk.de   
Schwarzwald-Baar Klinikum Recruiting
Villingen-Schwenningen, Germany, 78052
Contact: Werner Jung, Prof. Dr.    +49(0)7721-93 ext 3061    Werner.Jung@sbk-vs.de   
Sponsors and Collaborators
IHF GmbH - Institut für Herzinfarktforschung
Bayer
Investigators
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Principal Investigator: Uwe Zeymer, Prof. Dr. Institut für Herzinfarktforschung (Institute for Cardiac Research)

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Responsible Party: IHF GmbH - Institut für Herzinfarktforschung
ClinicalTrials.gov Identifier: NCT03315650     History of Changes
Other Study ID Numbers: RIVA-PCI
First Posted: October 20, 2017    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by IHF GmbH - Institut für Herzinfarktforschung:
Non-valvular AF
ACS
PCI
NOAC
Rivaroxaban
Additional relevant MeSH terms:
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Atrial Fibrillation
Acute Coronary Syndrome
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants