Rivaroxaban in Patients With Atrial Fibrillation Undergoing PCI

Acute Coronary Syndrome Clinical Trial

— RIVA-PCI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03315650
• Other study ID #: RIVA-PCI
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: June 24, 2021

Study information

• Verified date: July 2021
• Source: IHF GmbH - Institut für Herzinfarktforschung
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 after index PCI.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1632
• Est. completion date: June 24, 2021
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Germany	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

Sponsors (2)

Lead Sponsor	Collaborator
IHF GmbH - Institut für Herzinfarktforschung	Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Treatment adherence of patients	Patient-reported information on their adherence to the antithrombotic treatment strategy	14 months