Trial to Evaluate Anticoagulation Therapy in Hemodialysis Patients With Atrial Fibrillation

• Status: Completed
• Trial end date: 2019-08-12
• Target enrollment: 0
• Participant gender: All

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) .

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Christopher Granger; Christopher Granger, MD
• Collaborator: Bristol-Myers Squibb
• Treatments: Apixaban; Warfarin

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 < 8.5g/dL, history of intracranial hemorrhage, active bleeding, recent gastrointestinal bleed or retroperitoneal bleed, severe hepatic impairment, or anaphylactic reaction to apixaban)

• Moderate or severe mitral stenosis

• Conditions other than AF that require anticoagulation such as mechanical prosthetic valve, deep venous thrombosis, or pulmonary embolism

• Need for aspirin at a dose > 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