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Clinical Trials

Date: 2014-08-25

Type of information: Presentation of results at a congress

phase: 3b

Announcement: presentation of results at the European Society of Cardiology (ESC) Congress 2014

Company: Bayer Healthcare (Germany)

Product: Xarelto® (rivaroxaban)

Action mechanism: anticoagulant agent/oral direct Factor Xa inhibitor

Disease: patients with atrial fibrillation undergoing cardioversion

Therapeutic area: Cardiovascular diseases

Country:

Trial details:

Latest news:

  • • On August 25, 2014, Bayer HealthCare announced that results from the Phase IIIb exploratory X-VeRT study investigating the oral Factor Xa inhibitor Xarelto® (rivaroxaban) in patients with non-valvular atrial fibrillation (AF) undergoing elective cardioversion will be presented in a Hot Line Session during the upcoming ESC Congress 2014 in Barcelona, Spain, August 30 - September 3, 2014. The X-VeRT study is the first prospective trial comparing the benefit-risk profile of a novel oral anticoagulant with dose-adjusted warfarin in AF patients undergoing elective cardioversion: The X-VeRT Trial: A comparison of oral rivaroxaban once daily with dose-adjusted Vitamin K Antagonists in patients with non-valvular atrial fibrillation undergoing elective cardioversion
  • Sub-analyses from ROCKET AF and ATLAS ACS 2-TIMI 51 studies providing further insights into the clinical utility of rivaroxaban across arterial thromboembolic conditions include the following:  - Higher risk of death and stroke in patients with persistent versus paroxysmal atrial fibrillation: results from the ROCKET AF trial
  • - Digoxin use in patients with atrial fibrillation is associated with adverse cardiac outcomes: results from the ROCKET AF trial
  • -  Patients with native aortic stenosis represent a high-risk subgroup in non-valvular atrial fibrillation - Results from ROCKET AF
  • - Rivaroxaban in patients after an acute coronary syndrome with cardiac biomarker elevation: insights from the ATLAS ACS 2-TIMI 51 trial.
  • Results from the Phase IIa X-PLORER study on once-daily rivaroxaban compared to unfractionated heparin after elective PCI in patients with coronary artery disease (CAD) will also be presented: Rivaroxaban in elective percutaneous coronary intervention (PCI) to treat stable coronary artery disease
  • Independently, the Thrombosis Research Institute (TRI) will present new data from GARFIELD AF (Global Anticoagulant Registry in the FIELD), an observational, multicentre Registry of men and women with newly diagnosed AF and one or more additional investigator determined risk factors for stroke. The GARFIELD AF Registry is an academic research initiative, led by the TRI and a multi-disciplinary Steering Committee, supported by an unrestricted educational grant from Bayer Pharma.
  • - International normalized ratio control and 1-year outcomes in patients with newly diagnosed atrial fibrillation: the GARFIELD Registry
  • - Is cardiovascular death a primary driver of mortality in higher age groups of patients with non-valvular atrial fibrillation? Results from the GARFIELD Registry- ‘Truly low-risk’ patients with newly diagnosed non-valvular atrial fibrillation at risk of stroke: 1-year outcomes from the GARFIELD Registry
 

Is general: Yes