Non-valvular Atrial FibrillationRIVA-PCINCT03315650
Rivaroxaban in Patients With Atrial Fibrillation Undergoing PCI
An observational study of Non-valvular Atrial Fibrillation and Acute Coronary Syndrome, run by IHF GmbH - Institut für Herzinfarktforschung at 13 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-valvular Atrial Fibrillation, Acute Coronary Syndrome, Percutaneous Coronary Intervention
- How many people
- 1,632 participants
- Where
- 13 sitesGermany
- Study dates
- 1 Jan 2018to 24 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive, unselected recruitment of patients fulfilling the eligibility criteria.
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Germany13 sites
Kerckhoff-Klinik
Bad Nauheim, 61231
Segeberger Kliniken
Bad Segeberg, 23795
Gesundheitszentrum Bitterfeld-Wolfen
Bitterfeld-Wolfen, 06749
Klinikum Links der Weser
Bremen, 28277
Krankenhaus Buchholz
Buchholz, 21244
Klinikum Coburg
Coburg, 96450
SLK-Kliniken Heilbronn
Heilbronn, 74078
Städtisches Klinikum Ludwigshafen
Ludwigshafen, 67063
Universitätsklinikum Mannheim
Mannheim, 68167
Klinikum der Universität München , Campus Großhadern
Munich, 81377
Kreisklinikum Siegen
Siegen, 57076
Robert-Bosch-Krankenhaus
Stuttgart, 70376
Schwarzwald-Baar Klinikum
Villingen-Schwenningen, 78052
About this study
Official title: 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.
Read the 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
- Keywords
- Non-valvular AF, ACS, PCI, NOAC, Rivaroxaban
- Medical subject headings
- Acute Coronary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 months
Secondary outcomes (3)
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)
Measured: 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)
Measured: 32 months
Treatment adherence of patients
Patient-reported information on their adherence to the antithrombotic treatment strategy
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start1 Jan 2018
- Primary completion31 Mar 2020
- Study completion24 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-valvular Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,632 participants (actual)
Sponsor and investigators
- Lead sponsor
- IHF GmbH - Institut für Herzinfarktforschung
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Uwe Zeymer, Prof. Dr., Principal investigator, Institut für Herzinfarktforschung (Institute for Cardiac Research)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03315650
- Sponsor's protocol ID
- RIVA-PCI
- Acronym
- RIVA-PCI
- Status last verified
- Jul 2021
- First submitted
- 10 Oct 2017
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 36493580
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RIVA-PCI Registry - Prospective Registry of Rivaroxaban in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03315650
- Acronym / sponsor ID
- RIVA-PCI / RIVA-PCI
- Conditions
- Non-valvular Atrial Fibrillation, Acute Coronary Syndrome, Percutaneous Coronary Intervention, Antithrombotic Therapy
- Keywords
- Non-valvular AF, ACS, PCI, NOAC, Rivaroxaban
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,632 participants (actual)
- Lead sponsor
- IHF GmbH - Institut für HerzinfarktforschungUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 24 Jun 2021 (actual)
- First posted
- 20 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive, unselected recruitment of patients fulfilling the eligibility criteria.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Evaluation of antithrombotic medication during long-term follow-up
Time frame: 14 months
Adverse Events during baseline and follow-up
Time frame: 32 months
Treatment adherence of patients
Time frame: 14 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Derived from this study: PubMed 36493580Zeymer 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uwe Zeymer, Prof. Dr. principal investigator
Institut für Herzinfarktforschung (Institute for Cardiac Research)
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-valvular Atrial Fibrillation and Acute Coronary Syndrome, run by IHF GmbH - Institut für Herzinfarktforschung at 13 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antithrombotic combination therapies (treatment patterns) in patients with non-valvular AF undergoing PCI (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03315650, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.