DAN-WAR-D - Danish Warfarin-Dialysis Study: Safety and efficacy of warfarin in patients with atrial fibrillation on dialysis -A nationwide parallel-group open randomized clinical trial - 02022018

Rigshospitalet0 个研究点目标入组 718 人开始时间: 2022年12月1日最近更新: 2024年7月22日

适应症

试验速览

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•>=18 years on chronic dialysis due to end-stage renal disease with de novo diagnosis of non-valvular paroxysmal, persistent or permanent atrial fibrillation OR non-treated (>2 months) prevalent paroxysmal, persistent or permanent atrial fibrillation as documented an electrocardiogram or an episode of =30 seconds on Holter monitor, or episodes = 6 minutes on event recorders or any other recording device.

•CHA2DS2-VASc Score =1, Cerebrovascular malformations, Arterial aneurisms, Ulcers or wounds (Wagner grad >1), Bacterial endocarditis < 3 months, Active bleeding contraindicating anticoagulation, Any non-elective and/or non-ambulant surgery <7 days, Cerebral hemorrhage <4 weeks, Thrombocytopenia (platelet count <100 × 109/L) <30 days., Severe liver insufficiency (spontaneous international normalized ratio >1.5) <30 days., Known intolerance to warfarin, Other indications for oral anticoagulation treatment (pulmonary embolism < 6months, deep vein thrombosis <3months, prior atrial fibrillation, mechanical heart valve prosthesis) - irrespective of whether treatment is implemented, Use of hypericum perforatum / St. John’s Wort, Uncontrolled hypertension (repeat blood pressure >180/110mmhg) < 30 days, Uncontrolled hyperthyroidism (thyroid-stimulating hormone <0.1µIU/mL) <30 days, Pregnancy or lactation, Participation in other ongoing intervention trials adjudged to influence study outcomes, Ongoing dual antiplatelet treatment, Malignancy (with exception of non-melanoma skin cancer) with recent < 1 year, ongoing, or planned curative, or palliative chemo- , radiation-, and/or scheduled surgical therapy, Endoscopy with gastrointestinal ulcer <1 month, Esophageal varices, Autoimmune og genetic coagulation disorders, Congenital alactasia, Lapp Lactase deficiency or glucose-galactose malabsorption, Pending spinal tap

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