RIVA-PCI: Rivaroxaban in Patients With Atrial Fibrillation Undergoing PCI

Sponsor

IHF GmbH - Institut für Herzinfarktforschung (Other)

Overall Status

Completed

CT.gov ID

NCT03315650

Collaborator

Bayer (Industry)

1,632

Enrollment

Locations

41.7

Actual Duration (Months)

125.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

Study Type:

Observational

Actual Enrollment :

1632 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 :

Jan 1, 2018

Actual Primary Completion Date :

Mar 31, 2020

Actual Study Completion Date :

Jun 24, 2021

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Kerckhoff-Klinik	Bad Nauheim	Germany	61231
2	Segeberger Kliniken	Bad Segeberg	Germany	23795
3	Gesundheitszentrum Bitterfeld-Wolfen	Bitterfeld-Wolfen	Germany	06749
4	Klinikum Links der Weser	Bremen	Germany	28277
5	Krankenhaus Buchholz	Buchholz	Germany	21244
6	Klinikum Coburg	Coburg	Germany	96450
7	SLK-Kliniken Heilbronn	Heilbronn	Germany	74078
8	Städtisches Klinikum Ludwigshafen	Ludwigshafen	Germany	67063
9	Universitätsklinikum Mannheim	Mannheim	Germany	68167
10	Klinikum der Universität München , Campus Großhadern	Munich	Germany	81377
11	Kreisklinikum Siegen	Siegen	Germany	57076
12	Robert-Bosch-Krankenhaus	Stuttgart	Germany	70376
13	Schwarzwald-Baar Klinikum	Villingen-Schwenningen	Germany	78052