Related trials
ENGAGE-AF TIMI 48 High dose, 2013 - edoxaban vs warfarin standard dose
ARISTOTLE, 2011 - apixaban vs warfarin standard dose
AVERROES, 2011 - apixaban vs aspirin
ROCKET-AF, 2010 - rivaroxaban vs warfarin standard dose
ACTIVE A, 2009 - aspirin + clopidogrel vs aspirin
RE-LY (150mg), 2009 - dabigatran 150mg vs warfarin standard dose
RE-LY (110mg), 2009 - dabigatran 110mg vs warfarin standard dose
Lip (phase 2 AZD0837), 2009 - AZD0837 vs warfarin standard dose
AMADEUS, 2008 - idraparinux vs warfarin standard dose
PETRO (150mg), 2007 - dabigatran 150mg vs warfarin standard dose
ACTIVE W, 2006 - aspirin + clopidogrel vs anticoagulant
Japanese AF Trial, 2006 - aspirin vs control
SPORTIF V, 2005 - ximelagatran vs warfarin standard dose
NASPEAF (triflusal + coumadin medium dose vs coumadin standard dose), 2004 - triflusal+coumadin medium dose vs coumadin standard dose
NASPEAF (triflusal+coumadin medium dose vs triflusal), 2004 - triflusal+coumadin medium dose vs triflusal
NASPEAF (triflusal vs coumadin standard dose)), 2004 - triflusal vs coumadin standard dose
SAFT(warfarin low dose + aspirin vs no treatment), 2003 - warfarin low dose + aspirin vs control
SPORTIF III, 2003 - ximelagatran vs warfarin standard dose
SPORTIF II (ximelagatran vs warfarin standard dose), 2002 - ximelagatran vs warfarin standard dose
PATAF (coumadin low dose vs coumadin standard dose), 1999 - coumadin low dose vs coumadin standard dose
PATAF (vs coumadin standard dose), 1999 - aspirin vs coumadin standard dose
LASAF(aspirin vs no treatment), 1999 - aspirin vs control
PATAF (vs coumadin low dose), 1999 - aspirin vs coumadin low dose
AFASAK II (aspirin vs warfarin low dose), 1998 - aspirin vs warfarin low dose
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See also:
All atrial fibrillation clinical trials
All clinical trials of new oral anticoagulants
All clinical trials of edoxaban
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Treatments
Studied treatment |
edoxaban 60mg once daily
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Control treatment |
warfarin (INR 2-3)
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Remarks |
a third arm received a low dose of edoxaban, 30mg.
The allocated dose was halved if any of the
following characteristics were present at the time
of randomization or during the study: estimated
creatinine clearance of 30 to 50 ml per minute,
a body weight of 60 kg or less, or the concomitant
use of verapamil or quinidine (potent
P-glycoprotein inhibitors) |
Patients
Patients |
AF patients (CHADS2 >=2) |
Inclusion criteria |
documented AF within the prior 12 months; moderate to high risk of stroke, as defined by CHADS2 index score of at least 2 |
Exclusion criteria |
Transient atrial fibrillation secondary to other reversible disorders; moderate or severe mitral stenosis, unresected atrial myxoma, or a mechanical heart valve; contraindication for anticoagulant agents; conditions associated with high risk of bleeding; known or suspected hereditary or acquired bleeding disorders |
Method and design
Randomized effectives |
7035 / 7036 (studied vs. control) |
Design |
Parallel groups |
Blinding |
double blind |
Follow-up duration |
2.8 years |
Number of centre |
1393 |
Geographic area |
46 countries |
Primary endpoint |
stroke, systemic embolic events and all-cause mortality |
Results
No results available for this trial
- no clinical endpoint reported
Meta-analysis of all similar trials:
antithrombotics in atrial fibrillation for primary prevention of thromboembolic events
direct factor Xa inhibitors in atrial fibrillation for all type of patients
new oral anticoagulants in atrial fibrillation for all type of patients
Reference(s)
TrialResults-center ID |
TRC9825
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Trials register # |
NCT00781391
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Ruff CT, Giugliano RP, Antman EM, Crugnale SE, Bocanegra T, Mercuri M, Hanyok J, Patel I, Shi M, Salazar D, McCabe CH, Braunwald E.
Evaluation of the novel factor Xa inhibitor edoxaban compared with warfarin in patients with atrial fibrillation: design and rationale for the Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation-Thrombolysis In Myocardial Infarction study 48 (ENGAGE AF-TIMI 48)..
Am Heart J 2010;160:635-41
- 10.1016/j.ahj.2010.06.042
Pubmed
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Hubmed
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Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, �pinar J, Ruzyllo W, Ruda M, Koretsune Y, Betcher J, Shi M, Grip LT, Patel SP, Patel I, Hanyok JJ, Mercuri M, Antman EM.
Edoxaban versus warfarin in patients with atrial fibrillation..
N Engl J Med 2013 Nov 28;369:2093-104
Pubmed
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Hubmed
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