Stroke Prophylaxis With Apixaban in Chronic Kidney Disease Stage 5 Patients With Atrial Fibrillation

Launched by REGION STOCKHOLM · Jan 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called apixaban to see if it can help prevent strokes in patients with severe chronic kidney disease (stage 5) who also have a heart condition known as atrial fibrillation (AF). The researchers want to find out if taking apixaban can lower the chances of having a stroke without causing too many serious bleeding problems. They will compare the effects of apixaban with standard care, which does not include anticoagulation (medications that help prevent blood clots).

To participate in this study, you need to be an adult with stage 5 chronic kidney disease and a diagnosis of atrial fibrillation. This means your kidneys are not working well, and you may be on dialysis or have very low kidney function. You will be randomly assigned to either take apixaban or receive standard care for up to six years. Throughout the trial, doctors will monitor your health closely to track any strokes, major bleeding, or other serious health issues. If you are interested, it’s important to discuss with your healthcare provider to see if you qualify and to understand what participation would involve.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Signed Written Informed Consent
• • 2. 18 years of age or older
• • 3. 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).
• • 4. Diagnosis of chronic (i.e., repeated) paroxysmal, persistent, or permanent atrial fibrillation (AF) or atrial flutter (AFL)
• • 5. CHA2DS2-VASc score ≥2 or more for men ≥3 or more for women as an indication for oral anticoagulation
• • 6. Women of childbearing potential (WOCBP) should have a negative highly effective pregnancy test at screening and must agree to follow instructions for method(s) of contraception for the duration of treatment
• Exclusion Criteria:
• Participants may not be included in the study if any of the following criteria are met:
• • 1. AF or AFL due to reversible causes (e.g., thyrotoxicosis, pericarditis)
• • 2. Any degree of rheumatic mitral stenosis or moderate-to-severe non-rheumatic mitral stenosis at the time of inclusion into the study
• • 3. Any condition other than AF or AFL that requires chronic anticoagulation (e.g., a prosthetic mechanical heart valve, antiphospholipid syndrome).
• • 4. Any contraindication for anticoagulation including
• • 1. endocarditis
• • 2. documented intolerance for apixaban
• • 3. liver disease with documented coagulation disorder
• • 4. pregnancy or breast feeding
• • 5. Active bleeding or serious bleeding within 3 months, or
• • 1. documented hemorrhagic blood dyscrasia
• • 2. patients currently receiving dual antiplatelet therapy
• • 6. Planned for surgery
• • 1. kidney transplantation with a living donor within 3 months
• • 2. active on the kidney transplant waiting list at a kidney transplant center where apixaban use is prohibited
• • 3. valvular heart disease surgery
• • 7. Current use of strong inhibitors of both CYP3A4 and P-glycoprotein in accordance with the summary of product characteristics (SmPC) of apixaban or regular intake of non-steroidal anti-inflammatory drugs (NSAID) or cyclooxygenase-2 (COX2) inhibitors
• • 8. 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)
• • Being active on the kidney transplant waiting list is not an exclusion criterion if it is allowed according to the current clinical guidelines at the transplant clinic where the patient is registered. The patient must report changes in waiting list status to the investigator promptly.