Trial to Evaluate Anticoagulation Therapy in Hemodialysis Patients With Atrial Fibrillation

NCT02942407 | Completed Phase 4 Results DMC

• 1 other identifier: Pro00068545
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 58

Brief 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) .

Conditions

Atrial Fibrillation; End Stage Renal Disease

Keywords

Renal dialysis

Outcome Measures

Primary Outcomes (1)

• Number of Participants Experiencing ISTH (International Society on Thrombosis and Haemostasis) Major or Clinically Relevant Non-major Bleeding

  Assess the safety of apixaban versus warfarin regarding ISTH major bleeding or clinically relevant non-major bleeding events in patients with NVAF (nonvalvular atrial fibrillation) and ESRD (end-stage renal disease) on hemodialysis. Major bleeding event is defined as:Acute clinically overt bleeding (including access site related bleeding) accompanied by 1 or more of the following: Decrease in Hgb of 2g/dL or more with overt bleeding; Transfusion of 2 or more units of packed RBCs in the setting of an overt bleeding event; Bleeding within a critical site. Hemorrhagic stroke (primary or infarction with hemorrhagic conversion) were classified as major bleeds. Non-major bleeding event is defined as: Acute or sub-acute clinically overt bleeding (including access site related bleeding) that does not meet criteria for major bleeding \& results in Hospital admission for bleeding, physician guided medical or surgical treatment for bleeding, or change in antithrombotic therapy

  Randomization up to Month 15/Final Visit

Secondary Outcomes (8)

• Number of Participants Experiencing Stroke or Systemic Embolism

  Randomization up to Month 15/Final Visit

• Number of Participants Experiencing Mortality

  Randomization up to Month 15/Final Visit

• Persistence of Therapy

  Randomization up to Month 15/Final Visit

• Apixaban Plasma Concentration, Cmax

  0-12 hours post-dose

• Apixaban Plasma Concentration, Cmin

  0-12 hours post-dose

Other Outcomes (4)

• Number of Participants Experiencing Systemic Embolism

  Randomization up to Month 15/Final Visit

• Number of Participants Experiencing Stroke

  Randomization up to Month 15/Final Visit

• Number of Participants Experiencing Stroke, Systemic Embolism, Major Bleeding or All-cause Mortality

  Randomization up to Month 15/Final Visit

Study Arms (2)

apixaban

EXPERIMENTAL

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

Drug: apixaban

warfarin

EXPERIMENTAL

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

Drug: warfarin

Interventions

apixaban DRUG

oral anticoagulant

Also known as: Eliquis

apixaban

warfarin DRUG

oral anticoagulant

Also known as: Coumadin, Jantoven

warfarin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Christopher Granger, MD: lead
• Bristol-Myers Squibb: collaborator

Study Sites (58)

Nephrology Consultants

Huntsville, Alabama, 35805, United States

Location

The Medical Research Group, Inc.

Fresno, California, 93720, United States

Location

DaVita Clinical Trials, LLC

Long Beach, California, 90806, United States

Location

Southland Renal Medical Group

Long Beach, California, 90806, United States

Location

Valley Renal Medical Group Research

Northridge, California, 91324, United States

Location

Summit Nephrology Medical Group, Inc.

Roseville, California, 95661, United States

Location

Satellite Healthcare

San Jose, California, 95126, United States

Location

Washington Nephrology Associates

Washington D.C., District of Columbia, 20010, United States

Location

South Florida Nephrology Group PA, Research Division

Coral Springs, Florida, 33071, United States

Location

LG. Diagnostic, Inc. & Cosmetic Center

Miami, Florida, 33126, United States

Location

Nuren Medical and Research Center

Miami, Florida, 33144, United States

Location

Medical Professional Clinical Research Center

Miami, Florida, 33165, United States

Location

Boise Kidney and Hypertension Institute

Meridian, Idaho, 83642, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

NANI Research

Crystal Lake, Illinois, 60014, United States

Location

NANI Research

River Forest, Illinois, 60305, United States

Location

NANI Research

Fort Wayne, Indiana, 46804, United States

Location

Northwest Louisiana Nephrology

Shreveport, Louisiana, 71101, United States

Location

Anne Arundel Medical Center

Annapolis, Maryland, 21401, United States

Location

The Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

Washington Nephrology Associates

Takoma Park, Maryland, 20912, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

South Shore Nephrology

Plymouth, Massachusetts, 02360, United States

Location

Renal and Transplant Associates of New England

Springfield, Massachusetts, 01107, United States

Location

Paragon Health Neprhology Centre

Kalamazoo, Michigan, 49007, United States

Location

St. Clair Nephrology

Port Huron, Michigan, 48060, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Southwest Mississippi Nephrology, PLLC

Brookhaven, Mississippi, 39601, United States

Location

Southern Clinical Research Group, LLC

Gulfport, Mississippi, 39501, United States

Location

Nephrology & Hypertension Associates

Tupelo, Mississippi, 38801, United States

Location

Polack Renal, LLC

St Louis, Missouri, 63136, United States

Location

Sierra Nevada Nephrology Consultants

Reno, Nevada, 89511, United States

Location

Renal Medicine Associates

Albuquerque, New Mexico, 87109, United States

Location

Advanced Kidney Care of Hudson Valley

Poughkeepsie, New York, 12601, United States

Location

Durham Nephrology Associates

Durham, North Carolina, 27704, United States

Location

East Carolina University

Greenville, North Carolina, 27834, United States

Location

Eastern Nephrology Associates, PLLC.

Kinston, North Carolina, 28504, United States

Location

Eastern Nephrology Associates, PLLC

New Bern, North Carolina, 28562, United States

Location

HNC Dialysis, Ltd.

Columbus, Ohio, 43215, United States

Location

Northeast Clinical Research Ctr

Bethlehem, Pennsylvania, 18017, United States

Location

Penn State Health - Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Columbia Nephrology Associates

Columbia, South Carolina, 29203, United States

Location

South Carolina Nephrology and Hypertension

Orangeburg, South Carolina, 29118, United States

Location

Sumter Medical Specialists

Sumter, South Carolina, 29150, United States

Location

Regional Health Clinical Research

Rapid City, South Dakota, 57701, United States

Location

Knoxville Kidney Center

Knoxville, Tennessee, 37923, United States

Location

Southwest Houston Research, Ltd.

Houston, Texas, 77099, United States

Location

Lubbock Vascular Access Center

Lubbock, Texas, 79416, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Washington Nephrology Associates

Alexandria, Virginia, 22304, United States

Location

University of Virgina Health System

Charlottesville, Virginia, 22908, United States

Location

TPMG Clinical Research

Newport News, Virginia, 23606, United States

Location

Valley Nephrology Associates

Roanoke, Virginia, 24014, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

Nephrology and Hypertension Associates

Bluefield, West Virginia, 24701, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Aspirius Research Institute

Wausau, Wisconsin, 54401, United States

Location

Related Publications (23)

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  PMID: 36335914 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Kidney Failure, Chronic

Interventions

apixaban; Warfarin; Vitamin B 6

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Picolines; Pyridines

Limitations and Caveats

PK data are not final and are undergoing further modeling and analyses that will be reported in a separate manuscript.

Results Point of Contact

• Title: Christopher Granger, MD
• Organization: Duke Universitey

christopher.granger@duke.edu

919-668-8900

Study Officials

• Christopher Granger, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Glenn Chertow, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 14, 2016
• First Posted: October 24, 2016
• Study Start: December 1, 2016
• Primary Completion: July 27, 2019
• Study Completion: August 12, 2019
• Last Updated: December 29, 2020
• Results First Posted: December 29, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (58)