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ROCKET AF
Rivaroxaban meets primary end
point
The First oral Xa is non-Inferior to
Warfarin in AF
Background
• Rivaroxaban (BAY 59-7939) is an oral
anticoagulant invented and manufactured by
Bayer; in a number of countri...
• It is the first available orally active
direct factor Xa inhibitor.
• Rivaroxaban is well absorbed from the gut
and maxi...
• Rivaroxaban is an oxazolidinone derivative
optimized for inhibiting both free Factor Xa
and Factor Xa bound in the
proth...
• Inhibition of Factor Xa interrupts the intrinsic
and extrinsic pathway of the
blood coagulation cascade, inhibiting
both...
• ROCKET AF is double-blind phase 3 study in
more than 14 000 patients with nonvalvular
atrial fibrillation (AF).
• They w...
• The study was led by the Duke Clinical
Research Institute, Durham, NC, and an
international academic executive committee.
Higher Risky AF
• It has recently been reported that the patients
enrolled in ROCKET-AF are at higher risk of
stroke than ...
• CHADS2 is a tool used by doctors to assess 
stroke risk and subsequent need for 
anticoagulation therapy in patients wit...
Results 
• Non Inferiority was met with regard to   all-
cause stroke and non-central nervous system 
systemic embolism . ...
CME questions
• In Re-Ly trial , risk of hemorrhagic stoke with 
warfarin compared to Dabigatran 150 mg po 
Twice daily wa...
• 4-Four fold but statistically significant
• In the RE-LY trial, the rate of hemorrhagic stroke 
was 0.38% per year in th...
• The doses in mg approved by FDA for
Dabigatran
• Is
• 1- 150 & 75
• 2-150 & 110
• 3-not yet approved by FDA
• 1- 150 & 75
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Transcript of "Rocket af"

  1. 1. ROCKET AF Rivaroxaban meets primary end point The First oral Xa is non-Inferior to Warfarin in AF
  2. 2. Background • Rivaroxaban (BAY 59-7939) is an oral anticoagulant invented and manufactured by Bayer; in a number of countries it is marketed as Xarelto.
  3. 3. • It is the first available orally active direct factor Xa inhibitor. • Rivaroxaban is well absorbed from the gut and maximum inhibition of factor Xa occurs four hours after a dose. The effects lasts 8–12 hours, but factor Xa activity does not return to normal within 24 hours so once-daily dosing is possible.
  4. 4. • Rivaroxaban is an oxazolidinone derivative optimized for inhibiting both free Factor Xa and Factor Xa bound in the prothrombinase complex. • It is a highly selective direct Factor Xa inhibitor with oral bioavailability and rapid onset of action.
  5. 5. • Inhibition of Factor Xa interrupts the intrinsic and extrinsic pathway of the blood coagulation cascade, inhibiting both thrombin formation and development of thrombi. Rivaroxaban does not inhibit thrombin (activated Factor II), and no effects on platelets have been demonstrated.
  6. 6. • ROCKET AF is double-blind phase 3 study in more than 14 000 patients with nonvalvular atrial fibrillation (AF). • They were randomized to 20-mg rivaroxaban once daily (or 15 mg in patients with moderate renal impairment at screening) or to dose-adjusted warfarin (titrated to an international normalized ratio [INR] of 2.5).
  7. 7. • The study was led by the Duke Clinical Research Institute, Durham, NC, and an international academic executive committee.
  8. 8. Higher Risky AF • It has recently been reported that the patients enrolled in ROCKET-AF are at higher risk of stroke than those who have participated in other similar trials, with 90% having a CHADS2 score of 3 or higher compared with fewer than 50% of those enrolled in four comparable studies: RE-LY, ACTIVE W,AMADEUS, and SPORTIF V.
  9. 9. • CHADS2 is a tool used by doctors to assess  stroke risk and subsequent need for  anticoagulation therapy in patients with AF;  the higher the score, the greater the risk of  stroke.
  10. 10. Results  • Non Inferiority was met with regard to   all- cause stroke and non-central nervous system  systemic embolism .  • The rates of the composite of major and  nonmajor clinically relevant bleeding were  comparable (the primary safety end point).
  11. 11. CME questions • In Re-Ly trial , risk of hemorrhagic stoke with  warfarin compared to Dabigatran 150 mg po  Twice daily was • 1- two folds • 2-no difference • 3-three folds but not statistically significant. • 4-Four fold but statistically significant . 
  12. 12. • 4-Four fold but statistically significant • In the RE-LY trial, the rate of hemorrhagic stroke  was 0.38% per year in the warfarin group,  compared with 0.12% per year with 110 mg of  dabigatran (P < .001) and 0.10% per year with  150 mg of dabigatran (P < .001). These data  revealed that warfarin had an almost 3-fold  increase in hemorrhagic stroke compared with  dabigatran 110 mg and an almost 4-fold increase  in hemorrhagic stroke compared with dabigatran  150 mg. Both attained statistical significance.
  13. 13. • The doses in mg approved by FDA for Dabigatran • Is • 1- 150 & 75 • 2-150 & 110 • 3-not yet approved by FDA
  14. 14. • 1- 150 & 75
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