Trial to Evaluate Anticoagulation Therapy in Hemodialysis Patients With Atrial Fibrillation (RENAL-AF)

Christopher Granger, MD

Status and phase: Completed; Phase 4

Conditions: Atrial Fibrillation; End Stage Renal Disease

Treatments: Drug: warfarin; Drug: apixaban

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02942407

Pro00068545

Details and patient eligibility

About

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) .

Full description

This is a multicenter study in adult patients with AF and ESRD who are on hemodialysis and who have stroke risk factors making them candidates for oral anticoagulation. Patients will be randomized to apixaban versus warfarin, and will be treated for up to 15 months.

Enrollment: 154 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

154 participants in 2 patient groups

apixaban

Experimental group

Description:

apixaban 5 mg twice daily (apixaban 2.5 mg twice daily for selected patients)

Treatment:

Drug: apixaban

warfarin

Experimental group

Description:

warfarin daily dose adjusted to target International Normalized Ration(INR) of 2-3

Treatment:

Drug: warfarin