{"id":11354,"date":"2024-08-14T09:42:54","date_gmt":"2024-08-14T09:42:54","guid":{"rendered":"https:\/\/www.friendly-bartik.94-130-216-58.plesk.page\/axadia\/"},"modified":"2024-12-16T13:12:46","modified_gmt":"2024-12-16T13:12:46","slug":"axadia","status":"publish","type":"page","link":"https:\/\/www.af-net.eu\/en\/axadia\/","title":{"rendered":"AXADIA"},"content":{"rendered":"\n
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AXADIA<\/strong>-AFNET 8<\/h2>\n\n\n\n
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Safety Study A<\/strong>ssessing Oral Anticoagulation with Apixa<\/strong>ban versus Vitamin-K Antagonists in Patients with Atrial Fibrillation (AF) and End-Stage Kidney Disease (ESKD) on Chronic Hemodia<\/strong>lysis Treatment<\/p>\n<\/div>\n<\/div>\n<\/div><\/div>\n\n\n\n

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Study design<\/strong><\/h2>\n\n\n\n
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Investigator-initiated, national, open-label, randomised, multicentre, phase IIIb study to evaluate the safety of the new oral anticoagulant apixaban versus the Vitanin-K anatagonist phenprocoumon in the prevention of bleeding and thromboembolic events in patients with chronic kidney disease (CKD stage 5D) with non-valvular atrial fibrillation.<\/p>\n<\/div>\n\n\n\n

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Inclusion Criteria<\/strong><\/h5>\n\n\n\n

\"\" End-stage kidney disease (ESKD) with chronic hemodialysis treatment 3 times per week (with about at least 3.5 hours per dialysis)<\/p>\n\n\n\n

\"\" Chronic (i.e. repeated) paroxysmal, persistent or permanent atrial fibrillation (AF) or atrial flutter (AFL) documented by standard or Holter ECG on at least 2 separate days before (or apart from) hemodialysis procedures<\/p>\n\n\n\n

\"\" Increased risk of stroke or systemic embolism identified by a CHA2DS2-VASc score of 2 or more as an indication for oral anticoagulation<\/p>\n\n\n\n

\"\" Patients with ischemic stroke that meet the above criteria, can be included after more than 3 months if not severely handicapped (modified Rankin scale 0 or 1 of 6, i.e. no symptoms or no significant disability and able to carry out all usual activities, despite some symptoms (Farrell, Godwin, Richards, and Warlow (1991))<\/p>\n\n\n\n

\"\" Males and females, aged 18 or older<\/p>\n<\/div>\n\n\n\n

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Exclusion Criteria<\/strong><\/h5>\n\n\n\n

\"\" AF or AFL due to reversible causes (e.g., thyrotoxicosis, pericarditis)<\/p>\n\n\n\n

\"\" Patients with a new onset of hemodialysis within the last 3 months<\/p>\n\n\n\n

\"\" Clinically significant (moderate or severe) aortic and mitral stenosis<\/p>\n\n\n\n

\"\" Conditions other than AF or AFL that require chronic anticoagulation (e.g., a prosthetic mechanical heart valve).<\/p>\n\n\n\n

\"\" Active infective endocarditis<\/p>\n\n\n\n

\"\" Any planned interventional or surgical AF or AFL ablation procedure<\/p>\n\n\n\n

\"\" Any active bleeding<\/p>\n\n\n\n