Design and rationale of a randomised controlled trial comparing apixaban to phenprocoumon in patients with atrial fibrillation on chronic haemodialysis::the AXADIA-AFNET 8 study

Introduction Patients with end-stage kidney disease requiring maintenance haemodialysis treatment experience a dramatic cardiovascular morbidity and mortality. Due to the high atherosclerotic and arteriosclerotic burden and profound alterations in haemostasis, they frequently suffer and die from both thromboembolic and bleeding events. This is a particular concern in patients on haemodialysis with atrial fibrillation (AF). Controlled trials on the optimal anticoagulation in patients with AF on haemodialysis are not available. The randomised controlled phase IIIb AXADIA-AFNET 8 trial will evaluate the safety and efficacy of the factor Xa inhibitor apixaban in patients with AF requiring haemodialysis. Methods and analysis A total of 222 patients will be randomised in an open-labelled, 1:1 design to receive either apixaban 2.5mg twice daily or dose-adjusted vitamin K antagonist therapy (target international normalised ratio 2.0-3.0). All patients will be treated and followed up for a minimum of 6 months up to a maximum of 24 months. The primary outcome is major or clinically relevant, non-major bleedings or death of any cause. Secondary outcomes include stroke, cardiovascular death and other thromboembolic events, thus exploring the efficacy of apixaban. The first patient was randomised in June 2017. Ethics and dissemination The study protocol was approved by the Ethical Committee of the Landesaertzekammer, Westfalen-Lippe and the Medical Faculty of the University of Muenster, Muenster, Germany (reference number: 2016-598f-A). Written informed consent will be obtained from all patients prior to study participation, including their consent for long-term follow-up. AXADIA-AFNET 8 is an investigator-initiated trial. Sponsor is AFNET, Muenster, Germany. Study findings will be disseminated to Bristol-Myers Squibb, Munich, Germany, and Pfizer, Berlin, Germany, to the participating centres, at research conferences and in peer-reviewed journals. Trial registration numbers NCT02933697, Pre-results

The mimetic politics of lone-wolf terrorism

Written at a time of crisis in the project of social and political modernity, Fyodor Dostoevsky’s 1864 novel Notes from Underground offers an intriguing parallel for the twenty-first century lone-wolf; it portrays an abject, outcast, spiteful unnamed anti-hero boiling with rage, bitter with resentment and on the verge of radicalisation. A Girardian reading of the poetic truths contained in Dostoevsky’s work is able to provide important keys to explain the contemporary transformation from ‘fourth-wave’ religious terrorism to ‘fifth-wave’ lone-wolf terrorism. Such a reading argues that it is mimetic rivalry – rather than much-trumpeted forms of religious violence or cultural differences – that fuels the triangular relation between governments, terrorists and civilian victims at heart of terrorist acts. This approach is further able to blend social inquiry with an account of the individual, in fact anthropological, conditions of lone-wolf terrorism by tracing the globalisation of resentment and the individualisation of violence to the hyper-mimeticism characterising the globalisation of late modernity. Finally, a mimetic reading of ‘fifth-wave’ terrorism accounts for the turbulence of a global politics in which victimhood and scapegoating no longer have the ability to stabilise social order and warns against a future where violence proliferates and escalates unchecked

Planungsassistenzsysteme als Enabler für die modulare Produktionslogistik der Prozessindustrie 4.0: Vortrag gehalten beim Smart Process Manufacturing Kongress, 11.10.-12.10.2017, Würzburg

Viele Zweige der Prozessindustrie wie die Feinchemie- und Pharmaindustrie sehen sich derzeit einer wachsenden Unsicherheit und Dynamik von Marktverläufen, zunehmenden Anforderungen zur Produktdifferenzierung und kürzeren Produktlebenszyklen ausgesetzt. Die Einführung wandlungsfähiger Produktionskonzepte stellt für die Prozessindustrie eine Innovation und eine radikale Abkehr von den bisherigen Gestaltungsprinzipien dar. Zudem befähigen diese Konzepte zu einer Verkürzung der Planungs- und Entwicklungszeiten. Um diese Systeme in eine funktionsfähige Betriebsumgebung zu integrieren und schnell (re)konfigurieren zu können, müssen sie adäquat logistisch ver- und entsorgt werden und im Sinne von Industrie 4.0 als Cyper-physische Systeme „Plug & Produce“ funktionieren. Das Ziel des Vorhabens besteht in der Entwicklung eines simulationsbasierten Planungsassistenzsystems zur Planung und Bewertung dieser Systeme. Das Planungsassistenzsystem ermöglicht die schnelle und frequente (Re)konfiguration modularer Produktionssysteme, um kurzfristig auf veränderte Bedarfssituationen reagieren zu können