BridgeMD
SACK
EU CTIS ID: 2022-501600-10-00
What this study is testing
Our main objective is to study the efficacy and safety of apixaban as stroke prophylaxis in patients with CKD stage 5 and AF with or without dialysis treatment. Our study hypothesis is that compared to no anticoagulation, apixaban reduces the incidence of ischemic stroke and systemic embolism without causing an unacceptable increase in fatal or intracranial bleedings. The primary efficacy objective is to evaluate if treatment with apixaban and standard of care compared to standard of care without anticoagulation decreases the risk of ischemic stroke and systemic embolism (composite) in people with CKD stage 5 and AF (with or without dialysis).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 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.
You likely can't join if
- 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
See the full eligibility criteria
- 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 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).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.