Trial to Evaluate Anticoagulation Therapy in Hemodialysis Patients With Atrial Fibrillation

Completed · Phase 4

Conditions studied: Atrial Fibrillation, End Stage Renal Disease

In brief

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) .

Key facts

Study ID

NCT02942407

Run by

Christopher Granger, MD

People needed

154

Starts

2016-12-01

Expected to finish

2019-08-12

Last updated by the study team

2020-12-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• The Medical Research Group, Inc. — Fresno, California, United States
• DaVita Clinical Trials, LLC — Long Beach, California, United States
• Southland Renal Medical Group — Long Beach, California, United States
• Valley Renal Medical Group Research — Northridge, California, United States
• Summit Nephrology Medical Group, Inc. — Roseville, California, United States
• Satellite Healthcare — San Jose, California, United States
• Washington Nephrology Associates — Washington D.C., District of Columbia, United States
• South Florida Nephrology Group PA, Research Division — Coral Springs, Florida, United States
• LG. Diagnostic, Inc. & Cosmetic Center — Miami, Florida, United States
• Nuren Medical and Research Center — Miami, Florida, United States
• Medical Professional Clinical Research Center — Miami, Florida, United States
• Boise Kidney and Hypertension Institute — Meridian, Idaho, United States
• Northwestern University — Chicago, Illinois, United States
• NANI Research — Crystal Lake, Illinois, United States
• NANI Research — River Forest, Illinois, United States
• NANI Research — Fort Wayne, Indiana, United States
• Northwest Louisiana Nephrology — Shreveport, Louisiana, United States
• Anne Arundel Medical Center — Annapolis, Maryland, United States
• The Johns Hopkins University — Baltimore, Maryland, United States
• Washington Nephrology Associates — Takoma Park, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• South Shore Nephrology — Plymouth, Massachusetts, United States
• Renal and Transplant Associates of New England — Springfield, Massachusetts, United States
• Paragon Health Neprhology Centre — Kalamazoo, Michigan, United States
• Nephrology Consultants — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.