Phase 4
N=154
Trial to Evaluate Anticoagulation Therapy in Hemodialysis Patients With Atrial Fibrillation
Atrial Fibrillation · End Stage Renal Disease
Bottom Line
View on ClinicalTrials.gov: NCT02942407 ↗Enrolled (actual)
154
Serious AEs
14.3%
Results posted
Dec 2020
Primary outcome: Primary: Number of Participants Experiencing ISTH (International Society on Thrombosis and Haemostasis) Major or Clinically Relevant Non-major Bleeding — 21; 16 Participants — p=0.321
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- apixaban (Drug); warfarin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Christopher Granger, MD
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing ISTH (International Society on Thrombosis and Haemostasis) Major or Clinically Relevant Non-major Bleeding |
21; 16 | 0.321 |
| SECONDARY Number of Participants Experiencing Stroke or Systemic Embolism |
2; 2 | — |
| SECONDARY Number of Participants Experiencing Mortality |
21; 13 | — |
| SECONDARY Persistence of Therapy |
304.4; 279.6 | — |
| SECONDARY Apixaban Plasma Concentration, Cmax |
59.7; 97.9 | — |
| SECONDARY Apixaban Plasma Concentration, Cmin |
28.2; 49.7 | — |
| SECONDARY Area Under the Plasma Apixaban Concentration Curve From 0 to 12 Hours After Dose (AUCO-12) |
507; 868 | — |
| SECONDARY Apixaban Pharmacodynamics, Chromogenic Factor Xa Assay |
— | — |
| SECONDARY Adherence to Treatment With Apixaban or With Warfarin |
1; 1; 4; 2; 23; 15 | — |
Summary
This is a prospective, randomized, open-label, blinded end-point evaluation trial. The patient population consists of patients on hemodialysis who have atrial fibrillation (AF) and end-stage renal disease (ESRD) .
Eligibility Criteria
Inclusion Criteria
- Males and females, age at least 18 years, or the local age of consent, whichever is greater.
- Patients with AF defined as AF on ECG at enrollment or two or more reports of AF from separate monitoring events at least 2 weeks apart (report of ECG, Holter monitor, event monitor or implantable loop recorder).
- CHA2DS2-VASc score of ≥ 2.
- End-stage renal disease treated with hemodialysis for ≥ 3 months.
- Considered by the treating physician(s) to be candidate for oral anticoagulation.
- If of childbearing potential, be willing to avoid pregnancy during the study.
Exclusion Criteria
- Not considered by the treating physician(s) to be candidates for oral anticoagulation (for example, hemoglobin 81 mg a day or need for P2Y12 antagonist therapy (for example clopidogrel, prasugrel, or ticagrelor)
- Life expectancy < 3 months
- Anticipated kidney transplant within the next 3 months
- Prisoners or others who are involuntarily incarcerated or detained
- Pregnant, breastfeeding, or considering pregnancy.
- Participation in a clinical trial of an experimental treatment within the past 30 days
Data sourced from ClinicalTrials.gov (NCT02942407). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.