ROCKET AF
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- Randomized, double-blind, double-dummy phase 3 study comparing once daily oral rivaroxaban (a new oral factor Xa inhibitor) with adjusted-dose oral warfarin for the prevention of stroke in subjects with non-valvular AF - Population and treatment: 14 000 high-risk patients with AF 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 INR of 2.5) - Primary outcome: A composite of stroke and non-CNS embolism See the article at http://www.theheart.org/article/1148785.do
![ROCKET AF ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],K Mahaffey (Duke Clinical Research Institute, Durham, NC) American Heart Association 2010 Scientific Sessions](https://image.slidesharecdn.com/newitem-110706143559-phpapp01/85/ROCKET-AF-1-320.jpg)
![Primary efficacy outcome ,[object Object],ROCKET AF: Results (efficacy) Outcome Rivaroxaban (n=7081) Warfarin (n=7090) Hazard ratio (95% CI) p Primary end point, noninferiority 1.71 2.16 0.79 (0.66–0.96) <0.001 Primary end point, on-treatment superiority 1.70 2.15 0.79 (0.65–0.95) 0.015 Primary end point, intention-to-treat superiority 2.12 2.42 0.88 (0.74–1.03) 0.117 Vascular death, stroke, embolism 3.11 3.63 0.86 (0.74–0.99) 0.034 Hemorrhagic stroke 0.26 0.44 0.59 (0.37–0.93) 0.024 Ischemic stroke 1.34 1.42 0.94 (0.75–1.17) 0.581 Unknown stroke 0.06 0.10 0.65 (0.25–1.67) 0.366](data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7)
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ROCKET AF
- 4. ROCKET AF: Commentary* *All comments from Off orbit? ROCKET AF: Rivaroxaban noninferior to warfarin, but superiority analyses at odds (http://www.theheart.org/article/1148785.do) "I think it's totally fair to say that the trial did not demonstrate superiority by the high standard, according to the usual rules of clinical trials." - Dr Robert Califf (co–principal investigator) "If you take away only the conclusion of noninferiority, that's a step up; warfarin is a very difficult drug to use." - Dr Douglas Zipes "This was an impressive trial because the patients were so sick." - Dr Gordon Tomaselli
Editor's Notes
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- results
- commnetary