About RIVER
The RIVER Registry is a pioneering, independent outcomes research initiative led by an international steering committee under the auspices of the Thrombosis Research Institute (TRI), London, United Kingdom.
A Global Registry
The RIVER Registry focuses on the use of Rivaroxaban and the management of atrial fibrillation and stroke management in real world settings. Alongside GARFIELD-AF, RIVER will help improve the understanding of stroke prevention and long term management of patient outcomes.
2017 marked the end of the recruitment phase. The RIVER Registry exceeded its recruitment target of 5,000 patients.
Objectives
Thromboembolic stroke represents a major challenge and its prevention will be a defining component of population healthcare in the 21st century.
This worldwide observational programme aims to enhance the breadth and depth of understanding of stroke prevention in atrial fibrillation (AF), ultimately informing strategies to improve patient outcomes, safety and utilisation of healthcare resources.
The RIVER Registry offers a unique opportunity to obtain a comprehensive and contemporary description of the spectrum of patients with AF and their management worldwide as they evolve over time.
The RIVER Registry is important in bridging the gap between research and clinical practice, serving to increase awareness of the importance of thrombosis and its treatment.
Study Timeline
June 2015
The RIVER Registry is live in 17 countries around the world. The first country to be active in the registry was Poland, where the first patient enrolled in June 2015.
June 2017
The recruitment period of the RIVER Registry was completed on 09th June 2017 after 24 months of open recruitment from 306 sites around the globe.
Total Patients: 5,074
June 2019
The last patient visit is expected in June 2019. By this time, data will be collected and analysed to produce publications and papers relating to the real world evidence of managing patients with atrial fibrillation, and the treatment of stroke in this patient population.
Study Design
The RIVER Registry has recruited patients with newly diagnosed non-valvular AF and at least one risk factor for stroke. Patients were recruited over a period of 18-24 months. The follow-up period is for a minimum of 2 years to create a comprehensive database of treatment decisions and outcomes in everyday clinical practice.
Patient Eligibility
- Age 18 years and over
- New diagnosis of non-valvular atrial fibrillation (diagnosed within the last 6 weeks) with at least one additional investigator-determined risk factor for stroke
- Initial treatment with Rivaroxaban following AF diagnosis
Endpoints
- Describe changes in treatment practice
- Quantify rates of stroke and systemic embolism, major bleeding and all-cause mortality
- Assess therapy persistence (including discontinuation, interruption, and changes of regimen) and fluctuations in the international normalised ratio for patients on vitamin K antagonists
Quality Assurance
The RIVER Registry is governed by the highest academic and ethical standards in the generation, dissemination, and communication of its research findings.
Audit requirements
- 10% of all electronic case report forms (CRFs) are monitored against source documentation
- Electronic audit trail for all data modifications
- Critical variables subjected to additional audit
- Compliant with Declaration of Helsinki
-
About Our Governance
About our Governance
The Steering Committee provides global leadership for this important programme and engagement with diverse healthcare settings and disciplines, including cardiology, haematology, neurology, primary care and health economics.
Scientific Steering Committee
Professor Sylvia HaasProfessor Alexander G TurpieProfessor Jan Beyer-WestendorfProfessor Keith A A FoxProfessor A John CammProfessor Jean-Yves Le HeuzeyProfessor the Lord Kakkar -
About Atrial Fibrillation
About Atrial Fibrillation
Atrial fibrillation (AF) is an irregular heart beat that occurs due to abnormal electrical activity in the heart. It is the most common cause of cardiac arrhythmia, affecting approximately 2% of the overall population and around 10% of those over the age of 75.
Atrial fibrillation usually occurs in patients with other heart or lung conditions, but can also occur in otherwise healthy people. Atrial fibrillation can occur in presence of the various types of valvular heart diseases (for example, in patients with mitral stenosis or mechanical prosthetic valves); although AF caused by valvular heart diseases is relatively rare. The term ‘non-valvular AF’ is used to describe the majority of cases where rhythm disturbance is not associated with these problems. Patients recruited into River have a new diagnosis of ‘non-valvular’ atrial fibrillation.
Patients with AF are at increased risk of clot formation, due to the reduced movement of blood in the heart. If a clot dislodges and travels to the brain, this can result in a stroke. Patients with AF have around a fivefold higher risk of stroke than people with AF. Stroke patients with AF are also likely to have a worse outcome than stroke patients without AF, in terms of stroke severity, recurrences, functional deficits, cardiac complications and mortality. Patients with AF are therefore often given anticoagulants (e.g. warfarin) to reduce their stroke risk.
Risk factors for non-valvular atrial fibrillation
The likelihood of developing non-valvular AF increases with age. About 70% of AF cases occur in patients between the ages of 65 and 85 years. Approximately 1 in 6 patients with AF over 75 years of age are women.
