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Phase III ROCKET AF study

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Bayer HealthCare has announced that new data from the clinical development programme for its oral anticoagulant Xarelto® (rivaroxaban) will be presented at the American Heart Association (AHA) Scientific Sessions 2012 in Los Angeles, CA, US, November 3-7, 2012. These data will provide further insights into the clinical utility of rivaroxaban for patients at risk of dangerous blood clots across multiple venous and arterial thromboembolic (VAT) conditions.
Notable data analyses on Bayer’s rivaroxaban to be presented at AHA 2012 include:
Rivaroxaban Oral and Poster Presentations on Stroke Prevention in AF
  • Rivaroxaban is associated with a reduced risk of thromboembolic events and hemorrhagic stroke in patients with heart failure: Insights from ROCKET-AF
– Oral Presentation: AOS.405.01-Treatment of Arrhythmias: Pharmacological I; Presentation: 14365
– Monday, November 5, 2012; 10:00-10:15; Room 403a
  • Outcomes following cardioversion and atrial fibrillation ablation in patients treated with rivaroxaban and warfarin in the ROCKET AF Trial
Oral Presentation: AOS.406.04F-Managing Risk in Ablation of Atrial Fibrillation; Presentation: 19281
Wednesday, November 7, 2012; 11:15-11:30; Room 403b
  • Rivaroxaban compared with warfarin in patients with atrial fibrillation and diabetes: A subgroup analysis of the ROCKET AF trial
– Poster Session: APS.210.01-Diabetes Mellitus and CVD: Modulators of Risk I; Poster Board: 2091 – Presentation: 15544
– Monday, November 5, 2012; 15:00-16:30; Kentia Hall, Core 2
  • Plasma proteomics reveal greater upregulation of thrombomodulin in patients treated with rivaroxaban compared with warfarin
– Poster Session: APS.709.02a-Thrombosis: Risk Factors, Pharmacology and Diagnosis; Poster Board: 7109 – Presentation: 16503
– Wednesday, November 7, 2012; 09:30-11:00; Kentia Hall, Core 7
Full data from ROCKET AF were presented at the AHA Scientific Sessions meeting in 2010 and were published in the New England Journal of Medicine (NEJM) in September 2011. Xarelto has received marketing authorisation for the prevention of stroke and systemic embolism in patients with non-valvular AF in more than 70 countries worldwide, including the EU, the USand Japan.
Rivaroxaban Oral and Poster Presentations on Secondary Prevention of ACS
  • Evaluation of cardiac events in ATLAS ACS 2-TIMI 51
– Oral Presentation: AOS.716.01-Key Insights from Recent ACS Trials: Novel Therapeutics and Patient Outcomes; Presentation: 16014
– Monday, November 5, 2012; 15:45-16:00; Hall A-10
  • Temporal relationship between major hemorrhagic events and mortality among patients with Recent Acute Coronary Syndrome: Insights from ATLAS ACS 2-TIMI 51
– Oral Presentation: AOS.601.02a-Pharmacology for ACS and PCI; Presentation: 9944
– Tuesday, November 6, 2012; 14:30-14:45; Hall A-2
  • A net clinical outcome analysis comparing fatal or irreversible ischaemic and bleeding events in ATLAS ACS 2-TIMI 51
– Poster Session: APS.725.01-PCI: Procedural Considerations, Risk Factors and Complications; Poster Board: 7086 – Presentation: 13152
– Sunday, November 4, 2012; 15:00-16:30; Kentia Hall, Core 7
Full data from ATLAS ACS 2-TIMI 51 were presented at the American Heart Association (AHA) Scientific Sessions meeting in 2011 and were simultaneously published in the New England Journal of Medicine (NEJM). Rivaroxaban has been submitted for marketing authorisation to reduce secondary cardiovascular events in patients with ACS in more than 40 countries, including Europe and the US.
About Xarelto® (Rivaroxaban)
Rivaroxaban is the most broadly indicated new oral anticoagulant and is marketed under the brand name Xarelto®. To date, Xarelto has been approved for use in the following venous arterial thromboembolic (VAT) indications:
  • The prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors in more than 70 countries worldwide
  • The treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE) in adults in more than 70 countries worldwide
  • The prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery in more than 120 countries worldwide
Since the first approval of Xarelto in 2008, more than two and a half million patients worldwide have received Xarelto in daily clinical practice.
Rivaroxaban was discovered by Bayer HealthCare, and is being jointly developed with Janssen Research & Development, LLC. Xarelto is marketed outside the U.S. by Bayer HealthCare and in the US by Janssen Pharmaceuticals, Inc. (a Johnson & Johnson Company).
Anticoagulant medicines are potent therapies used to prevent or treat serious illnesses and potentially life threatening conditions. Before initiating therapy with anticoagulant medicines, physicians should carefully assess the benefit and risk for the individual patient.





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