XANTUS: rationale and design of a noninterventional study of rivaroxaban for the prevention of stroke in patients with atrial fibrillation.

Atrial fibrillation (AF) is associated with a fivefold increase in the risk of stroke. The Phase III ROCKET AF (Rivaroxaban Once-Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) trial showed that rivaroxaban, an oral, direct Factor Xa inhibitor, was noninferior to warfarin for the reduction of stroke or systemic embolism in patients with AF. Compared with warfarin, rivaroxaban significantly reduced rates of intracranial and fatal hemorrhages, although not rates of bleeding overall. XANTUS (Xarelto(®) for Prevention of Stroke in Patients with Atrial Fibrillation) is a prospective, international, observational, postauthorization, noninterventional study designed to collect safety and efficacy data on the use of rivaroxaban for stroke prevention in AF in routine clinical practice. The key goal is to determine whether the safety profile of rivaroxaban established in ROCKET AF is also observed in routine clinical practice. XANTUS is designed as a single-arm cohort study to minimize selection bias, and will enroll approximately 6,000 patients (mostly from Europe) with nonvalvular AF prescribed rivaroxaban, irrespective of their level of stroke risk. Overall duration of follow-up will be 1 year; the first patient was enrolled in June 2012. Similar studies (XANTUS-EL [Xarelto(®) for Prevention of Stroke in Patients with Nonvalvular Atrial Fibrillation, Eastern Europe, Middle East, Africa and Latin America] and XANAP [Xarelto(®) for Prevention of Stroke in Patients with Atrial Fibrillation in Asia-Pacific]) are ongoing in Latin America and Asia-Pacific. Data from these studies will supplement those from ROCKET AF and provide practical information concerning the use of rivaroxaban for stroke prevention in AF

An evaluation of exact matching and propensity score methods as applied in a comparative effectiveness study of inhaled corticosteroids in asthma

Peer reviewedPublisher PD

Left atrial thrombus resolution in atrial fibrillation or flutter:Results of a prospective study with rivaroxaban (X-TRA) and a retrospective observational registry providing baseline data (CLOT-AF)

BackgroundData on left atrial/left atrial appendage (LA/LAA) thrombus resolution after non–vitamin K antagonist (VKA) oral anticoagulant treatment are scarce. The primary objective of X-TRA was to explore the use of rivaroxaban for the resolution of LA/LAA thrombi in patients with nonvalvular atrial fibrillation (AF) or atrial flutter, with the CLOT-AF registry providing retrospective data after standard-of-care therapy in this setting.MethodsX-TRA was a prospective, single-arm, open-label, multicenter study that investigated rivaroxaban treatment for 6 weeks for LA/LAA thrombus resolution in patients with nonvalvular AF or atrial flutter and LA/LAA thrombus confirmed at baseline on a transesophageal echocardiogram (TEE). CLOT-AF retrospectively collected thrombus-related patient outcome data after standard-of-care anticoagulant treatment for 3 to 12 weeks in patients with nonvalvular AF or atrial flutter who had LA/LAA thrombi on TEE recorded in their medical file.ResultsIn X-TRA, patients were predominantly (95.0%) from Eastern European countries. The adjudicated thrombus resolution rate was 41.5% (22/53 modified intention-to-treat [mITT] patients, 95% CI 28.1%-55.9%) based on central TEE assessments. Resolved or reduced thrombus was evident in 60.4% (32/53 mITT patients, 95% CI 46.0%-73.6%) of patients. In CLOT-AF, the reported thrombus resolution rate was 62.5% (60/96 mITT patients, 95% CI 52.0%-72.2%) and appeared better in Western European countries (34/50; 68.0%) than in Eastern European countries (26/46; 56.5%).ConclusionX-TRA is the first prospective, multicenter study examining LA/LAA thrombus resolution with a non-VKA oral anticoagulant in VKA-naïve patients or in patients with suboptimal VKA therapy. Rivaroxaban could be a potential option for the treatment of LA/LAA thrombi

Cultural Sciences in the Focus. Speeches at the Occasion of the Dies Academicus

Der erste Band der neuen Schriftenreihe der Universitätsleitung der Universität Bamberg bietet den Text von fünf Festvorträgen, die Professoren der Otto- Friedrich-Universität Bamberg in den Jahren 2000 bis 2007 anläßlich des Dies Academicus ihrer Hochschule gehalten haben. Exemplarisch zeigen sie die Vielfalt, die interdisziplinäre Ausrichtung und den Beitrag der Geistes- und Kulturwissenschaften zur Profilbildung der Universität Bamberg: Rolf Bergmann: Das doppelte Deutsch. Europäischer und deutscher Wortschatz; Friedhelm Marx: Streitfälle. Literatur und Literaturwissenschaft der Gegenwart; Klaus van Eickels: Ehe und Familie im Mittelalter; Bert G. Fragner: Kulturkontakt und Kulturtransfer entlang der Seidenstraße. Ein Langzeitphänomen der eurasischen Geschichte; Wilfried Krings: Der gedeckte Platz am Katzentisch. Ansichten über die Geographie.The first volume of a new series of collected volumes edited by the president of the University of Bamberg contains the text of five lectures delivered by professors of the University of Bamberg in the years 2000-2007 at the occasion of the dies academicus of their university. These lectures show the diversity, the interdisciplinary scope and the contribution of the arts and cultural s ciences to the profile of the University of Bamberg: Rolf Bergmann: The double German langue. European and German vocabulary Friedhelm Marx: Cases of dissent. Literature and literary criticism today Klaus van Eickels: Marriage and the family in the Middle Ages Bert G. Fragner: Cultural contact and cultural transfer along the Silk Road. A long time phenomenon in the history of Eurasia Wilfried Krings: The set place at the side table. Opinions about geography

Look at the Audience? A Randomized Controlled Study of Shifting Attention From Self-Focus to Nonsocial vs. Social External Stimuli During Virtual Reality Exposure to Public Speaking in Social Anxiety

Background: Enhanced self-focused attention plays a central role in the maintenance and treatment of Social Anxiety and is targeted in contemporary cognitive behavioral therapy. Actual developments use Virtual Reality (VR) for behavioral training. However, no VR attention training combining exposure to public speaking with shifting attention from self-focus to external focus has been investigated, and no experimental evidence exists on different kinds of external cues as targets of attention. Therefore, we investigated the effects of an attention training during public speaking in VR and examined differential effects of an external focus on nonsocial vs. social stimuli. Methods: In this randomized controlled study, highly socially anxious participants were instructed to focus on either objects or the audience within a virtual speech task. We assessed the pre-post effects on affective reactions, self-perception, and attentional processes during public speaking as well as general Social Anxiety using subjective, physiological, and eye-tracking measures. Repeated-measures analyses of variance (ANOVAs) were calculated to detect changes from pretest to posttest over both groups, and time × group interaction effects. Results: Within the analysis sample (n = 41), anxiety during public speaking and fear of negative evaluation significantly decreased, with no significant differences between groups. No significant time effect, but a significant time × group effect, was found for the looking time proportion on the audience members' heads. Follow-up tests confirmed a significant increase in the social-focus group and a significant decrease in the nonsocial-focus group. For all other variables, except external focus and fear of public speaking, significant improvements were found over both groups. Further significant time x group effects were found for positive affect during public speaking, with a significant increase in the social focus, and no significant change in the nonsocial-focus group. Conclusion: Our findings suggest that attention training to reduce self-focus can be successfully conducted in VR. Both training versions showed positive short-term effects in the highly socially anxious, with particular advantages of an external social focus concerning eye contact to the audience and positive affect. Further research should investigate whether social focus is even more advantageous long term and if reinterpretations of dysfunctional beliefs could be achieved by not avoiding social cues