Stroke prophylaxis with Apixaban in Chronic Kidney Disease stage 5 patients with Atrial fibrillation (SACK)

Karolinska University Hospital0 个研究点目标入组 1,030 人开始时间: 2022年8月11日最近更新: 2024年7月22日

适应症

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•Signed Written informed consent (on paper or digital), Men or women =18 years, Ongoing treatment with any chronic dialysis treatment OR an estimated glomerular filtration rate (eGFR) <20 ml/min/1.73 m2 at least twice 3 months apart of which at least one occasion is <15 ml/min/1.73 m2 due to CKD during the last year (12 months)., Diagnosis of chronic (i.e., repeated) paroxysmal, persistent, or permanent atrial fibrillation (AF) or atrial flutter (AFL)., CHA2DS2-VASc score =2 for men or =3 or more for women as an indication for oral anticoagulation., Women of childbearing potential (WOCBP) should have a negative highly sensitive pregnancy test at screening and must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug.

•AF or AFL due to reversible causes (e.g., thyrotoxicosis, pericarditis)., Any degree of rheumatic mitral stenosis or moderate-to-severe non-rheumatic mitral stenosis at the time of inclusion into the study., Any condition other than AF or AFL that requires chronic anticoagulation (e.g., a prosthetic mechanical heart valve, antiphospholipid syndrome)., Any contraindication for anticoagulation including a) endocarditis, b) documented intolerance for apixaban, c) liver disease with documented coagulation disorder, d) pregnancy or breast feeding., Active bleeding or serious bleeding within 3 months, or a) documented hemorrhagic blood dyscrasia or a very high bleeding risk according to investigator, b) patients currently receiving dual antiplatelet therapy., Planned for surgery a) kidney transplantation with a living donor within 3 months, b) active on the kidney transplant waiting list at a kidney transplant center where apixaban use is prohibited, c) valvular heart disease surgery, Current use of strong inhibitors of both CYP3A4 and P-glycoprotein in accordance with the SmPC of apixaban (2,5 mg) or regular intake of NSAID or COX2 inhibitors., Any condition or circumstance in which the patient should not participate in the study according to the study investigator (reason documented in the pre-screening protocol).

发起方

Karolinska University Hospital