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New treatment option for Chronic Kidney Diseases
Official title Stroke Prophylaxis With Apixaban in Chronic Kidney Disease Stage 5 Patients With Atrial Fibrillation
ClinicalTrials.gov ID: NCT05679024
What this study is testing
What is Apixaban 2.5 milligram Oral Tablet?
Apixaban 2.5 milligram Oral Tablet is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic kidney diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Objective: To study the efficacy and safety of apixaban as stroke prophylaxis in patients with chronic kidney disease (CKD) stage 5 and atrial fibrillation (AF) with or without dialysis treatment. The study hypothesis is that compared to no anticoagulation, apixaban reduces the incidence of ischemic stroke without causing an unacceptable increase in fatal or intracranial bleeding events.
- Phase 3: a large, late-stage study
- Time commitment: about 12 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed Written Informed Consent
- 18 years of age or older
- 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...
- Diagnosis of chronic (i.e., repeated) paroxysmal, persistent, or permanent atrial fibrillation (AF) or atrial flutter (AFL)
- CHA2DS2-VASc score ≥2 or more for men ≥3 or more for women as an indication for oral anticoagulation
You likely can't join if
- Participants may not be included in the study if any of the following criteria are met:
- 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
- endocarditis
See the full eligibility criteria
- Signed Written Informed Consent
- 18 years of age or older
- 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...
- Diagnosis of chronic (i.e., repeated) paroxysmal, persistent, or permanent atrial fibrillation (AF) or atrial flutter (AFL)
- CHA2DS2-VASc score ≥2 or more for men ≥3 or more for women as an indication for oral anticoagulation
- 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
- Participants may not be included in the study if any of the following criteria are met:
- 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
- endocarditis
- documented intolerance for apixaban
- liver disease with documented coagulation disorder
- pregnancy or breast feeding
- Active bleeding or serious bleeding within 3 months, or
- documented hemorrhagic blood dyscrasia
- patients currently receiving dual antiplatelet therapy
- Planned for surgery
- kidney transplantation with a living donor within 3 months
- active on the kidney transplant waiting list at a kidney transplant center where apixaban use is prohibited
- valvular heart disease surgery
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Helsinki, Finland
- Tampere, Finland
- Turku, Finland
- Reykjavik, Iceland
- Oslo, Norway
- Stavanger, Norway
- Tromsø, Norway
- Tønsberg, Norway
- Falun, Dalarna County, Sweden
- Östersund, Jämtland County, Sweden
- Falun, Region Dalarna, Sweden
- Mora, Region Dalarna, Sweden
- Kalmar, Region Kalmar Län, Sweden
- Kalix, Region Norrbotten, Sweden
- Lund, Region Skåne, Sweden
- Malmö, Region Skåne, Sweden
- Umeå, Region Västerbotten, Sweden
- Sundsvall, Region Västernorrland, Sweden
- Västerås, Region Västmanland, Sweden
- Borås, Region Västra Götaland, Sweden
+ 12 more site(s).
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 study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Helsinki, Finland; Tampere, Finland; Turku, Finland; Reykjavik, Iceland; Oslo, Norway; Stavanger, Norway and 26 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.