See also:

ENGAGE-AF TIMI 48 High dose study, 2013	TRC9825
[NCT00781391]	download pdf: edoxaban | antithrombotics for atrial fibrillation

Treatments

Studied treatment	edoxaban 60mg once daily
Control treatment	warfarin (INR 2-3)
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
Trials register #	NCT00781391

• 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 | Hubmed | Fulltext
• 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 | Hubmed | Fulltext

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