Table 1:
Recently completed, ongoing and planned RCT of OAC versus no OAC in advanced CKD with AF.
| Study | Number and selection of patients | Intervention | Duration | Primary Outcome |
|---|---|---|---|---|
| VISIONAIRE | ∼1500 patients CKD5, CHA2DS2-VASc ≥2 | Randomized 1:1:2 to edoxaban 30 mg qd, VKA (INR 2–3), or no OAC | N/A | Composite of stroke or systemic embolism; major and clinically relevant non-major bleeding (ISTH definition) |
| SACK, NCT05679024 | 1400 CKD5 or CKD5D, CHA2DS2-VASc ≥2 for men or ≥3 for women | Apixaban 2.5 mg bid vs no OAC | 72 months or when 247 primary events have been reached, whichever comes first | Time to first thromboembolic event; time to dialysis access thrombosis; time to kidney replacement therapy; delayed graft function; thrombosis of renal artery or vein in patients undergoing kidney transplantation; time to major bleeding (ISTH definition) |
| AVKDIAL, NCT02886962 | 855 prevalent HD, CHA2DS2-VASc ≥2 | VKA (INR 2–3) vs no OAC | 2 years | Severe bleeding and thrombosis |
| DANWARD, NCT03862859 | 718 prevalent dialysis; incident AF only with CHA2DS2-VASc ≥2 | VKA (INR 2–3) vs no OAC | ≤4 years | TIA, ischemic or unspecific stroke; major bleeding (ISTH definition) |
| SAFE-Db, NCT03987711 | 151 prevalent HD/PD, CHADS-65 criteria: age ≥65 or age <65 years with one of: hypertension, diabetes, congestive heart failure, stroke/TIA or peripheral embolism | VKA (INR 2–3) vs apixaban 5 mg bida vs no OAC | 26 weeks | Pilot to test feasibility of larger trial: recruitment of target population within 2 years; ≥80% participants remain in study and on allocated treatment after Week 26 |
a2.5 mg bid in patients meeting the criteria for reduced dose.
bAs of March 2024, the study is completed, but results are not yet published in a peer-reviewed journal.
TIA: transient ischemic attack; ISTH: International Society on Thrombosis and Hemostasis.