AzTrials
AzTrials

Atrial FibrillationPhase 2SAFE-DNCT03987711

Strategies for the Management of Atrial Fibrillation in patiEnts Receiving Dialysis

A Phase 2 study testing Warfarin, Apixaban and No oral anticoagulation in people with Atrial Fibrillation and End Stage Renal Failure on Dialysis, run by Unity Health Toronto at 28 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The prevention of atrial fibrillation related thromboembolism in the dialysis population is unclear. While the practice of anticoagulation appears favorable in patients with mild-to-moderate chronic kidney disease, no patients with severe chronic kidney disease (estimated glomerular filtration rate <25 ml/min), and… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Warfarin, Apixaban and No oral anticoagulation
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
151 participants
Where
28 sitesin 2 countries
Study dates
10 Dec 2019to 31 Dec 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years.
  • Receiving maintenance hemodialysis or peritoneal dialysis for > 90 days.
  • History of AF or atrial flutter as defined by:
  • AF or atrial flutter on a 12 lead ECG at enrollment, and not due to a reversible cause, or (ii) AF or atrial flutter documented on two separate occasions, not due to a reversible cause, at least 1 day apart prior to enrollment. AF or atrial flutter may be documented by ECG, or as an episode lasting at least 30 seconds on a rhythm strip or Holter recording, or more than 30 minutes if using pacemaker or implantable cardioverter defibrillator (ICD) recordings, or (iii) AF or atrial flutter documented on one occasion, not due to a reversible cause, prior to enrollment and being treated with an oral anticoagulant for AF or atrial flutter at enrollment. [AF or atrial flutter may be documented by ECG, or as an episode lasting at least 30 seconds on a rhythm strip or Holter recording, or more than 30 minutes if using pacemaker or implantable cardioverter defibrillator (ICD) recordings, or mentioned in the medical record], or (iv) AF or atrial flutter documented on one occasion on ECG, not due to a reversible cause, prior to enrollment and at least one more episode of AF or atrial flutter mentioned in the medical record, or (v) AF or atrial flutter documented on one occasion in a cardiologist report, not due to a reversible condition, prior to enrollment.
  • Satisfying CHADS-65 criteria: i) Age ≥65 or ii) Age <65 and one of: hypertension, diabetes mellitus, congestive heart failure, stroke/transient ischemic attack or peripheral embolism.

Who cannot join

  • Moderate or severe mitral stenosis.
  • Conditions other than non-valvular atrial fibrillation that require oral anticoagulation, such as mechanical prosthetic valve, deep venous thrombosis, or pulmonary embolism.
  • Need for aspirin at a dose > 165 mg a day, or need for aspirin in combination with P2Y12 antagonist therapy.
  • Need for an interacting drug which precludes the safe use of apixaban.
  • Life expectancy < 6 months.
  • Scheduled live-donor kidney transplant in the next 6 months.
Show all 10Show fewer
  • A woman who is pregnant or breastfeeding or unwilling to pursue methods of contraception if < 12 months since the last menstrual period.
  • Co-enrollment in a clinical trial where the intervention is deemed to interfere with the adherence, safety or efficacy of the intervention provided herein.
  • Patient's attending physician(s) (e.g., nephrologist and/or cardiologist and/or neurologist) believes that oral anticoagulation is absolutely mandated.
  • Patient's attending physician(s) (e.g., nephrologist and/or cardiologist and/or neurologist) believes that oral anticoagulation is absolutely contraindicated.

Trial locations and contacts

28 sites in 2 countries.

28 sites in 2 countries

Canada24 sites

  • Royal Victoria Regional Health Centre

    Barrie, Ontario, L4M 6M2

  • Health Sciences North

    Greater Sudbury, Ontario, P3E 5J1

  • Nova Scotia Health Authority, QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V7

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

  • Kingston Health Sciences Centre - Kingston General Hospital

    Kingston, Ontario, K7L 2V7

  • London Health Sciences Centre

    London, Ontario, N6A 5A5

  • Hôpital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

  • Centre Hospitalier de l'Université de Montréal

    Montreal, Quebec, H2X 3E4

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Hôpital du Sacré-Cœur de Montréal

    Montreal, Quebec, H4J 1C5

  • McGill University Health Centre

    Montreal, Quebec, H8S 4K4

  • Halton Healthcare - Oakville Trafalgar Memorial Hospital

    Oakville, Ontario, L6M 0L8

  • Lakeridge Health Oshawa

    Oshawa, Ontario, L1G 2B9

  • The Ottawa Hospital - Riverside Campus

    Ottawa, Ontario

  • CHU de Québec - Université Laval

    Québec, Quebec, G1R 2J6

  • Regina General Hospital

    Regina, Saskatchewan, S4P 0W5

  • Surrey Memorial Hospital

    Surrey, British Columbia, V3V 0C6

  • Thunder Bay Regional Health Sciences Centre

    Thunder Bay, Ontario, P7B 6V4

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4G 3E8

  • Unity Health Toronto, at its St. Michael's Hospital site

    Toronto, Ontario, M5B 1W8

  • University Health Network - Toronto General Hospital

    Toronto, Ontario, M6K3S2

  • St. Joseph's Health Centre Toronto

    Toronto, Ontario, M6R 1B5

  • St. Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6

  • Seven Oaks General Hospital

    Winnipeg, Manitoba, R2V 3M3

Other trials in Canada

Australia4 sites

  • Nepean Hospital

    Kingswood, New South Wales, 2747

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031

  • Royal North Shore Hospital

    Saint Leonards, New South Wales, 2065

  • St. George Hospital

    Sydney

Other trials in Australia

About this study

Official title: Strategies for the Management of Atrial Fibrillation in patiEnts Receiving Dialysis (SAFE-D)

The prevention of atrial fibrillation related thromboembolism in the dialysis population is unclear. While the practice of anticoagulation appears favorable in patients with mild-to-moderate chronic kidney disease, no patients with severe chronic kidney disease (estimated glomerular filtration rate <25 ml/min), and specifically those receiving dialysis, have been included in randomized trials.Moreover, the effect of anticoagulation in the dialysis population may fundamentally differ from those studied in clinical trials. Accordingly, characterization of the optimal management strategy to reduce the risk of stroke and systemic embolism in patients with atrial fibrillation receiving dialysis is a priority. The overall goal of this pilot trial is to evaluate the feasibility of conducting a randomized controlled trial comparing anticoagulation strategies in patients with atrial fibrillation receiving dialysis (either hemodialysis or peritoneal dialysis).

Being tested
Warfarin, Apixaban, No oral anticoagulation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WarfarinDrug

    Also called Coumadin

    Individuals randomized to this arm will be exposed to dose-adjusted daily warfarin targeting an international normalized ratio (INR) of 2.0-3.0.

  • ApixabanDrug

    Also called Eliquis

    Individuals randomized to this arm will receive apixaban 5 mg twice daily (a reduced dose of 2.5 mg twice daily will be given to selected participants).

  • No oral anticoagulationOther

    No oral anticoagulation

Study groups in NCT03987711
Study groupRoleWhat they receive
WarfarinExperimentalIndividuals randomized to this arm will be exposed to dose-adjusted daily warfarin targeting an international normalized ratio (INR) of 2.0-3.0.
Receives: Drug: Warfarin
ApixabanActive comparatorIndividuals randomized to this arm will receive apixaban 5 mg twice daily (a reduced dose of 2.5 mg twice daily will be given to selected participants).
Receives: Drug: Apixaban
No oral anticoagulationActive comparatorIndividuals in this arm will be exposed to a treatment strategy in which no oral anticoagulation is prescribed.
Receives: Other: No oral anticoagulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment of the target population within 2 years

    Measured: 2 years from start of trial

  2. At least 80% of randomized participants remain in the trial and on the allocated study treatment at the end of the 26-week study period.

    Measured: 26 weeks

Secondary outcomes (9)

  1. Proportion of patients randomized to warfarin achieving a Time in the Therapeutic Range (TTR) >65%.

    Measured: 26 weeks

  2. >95% of randomized patients adhere to the enrollment criteria with respect to atrial fibrillation or atrial flutter

    Through adjudication of ECGs or other cardiac diagnostics

    Measured: End of trial

  3. Major bleeding

    As defined by the International Society of Thrombosis and Haemostasis (ISTH)

    Measured: 26 weeks

  4. Clinically relevant non-major bleeding

    As defined by the International Society of Thrombosis and Haemostasis (ISTH)

    Measured: 26 weeks

  5. Stroke and systemic embolism

    Measured: 26 weeks

  6. All cause mortality

    Measured: 26 weeks

  7. Non-fatal myocardial infarction

    Measured: 26 weeks

  8. Vascular events not related to dialysis access

    Measured: 26 weeks

  9. Events of special interest related to dialysis access, the dialysis procedure or the oral anticoagulants

    Thrombosis of fistula or graft; fistula or graft abandonment; thrombosis of dialysis catheter; red blood cell transfusions; calciphylaxis

    Measured: 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2019
  2. Study start10 Dec 2019
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
151 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03987711
Sponsor's protocol ID
SAFE-D-01
Acronym
SAFE-D
Status last verified
Jun 2023
First submitted
12 Jun 2019
Last updated
22 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Harel Z, Smyth B, Badve SV, Blum D, Beaubien-Souligny W, Silver SA, Clark E, Suri R, Mavrakanas TA, Sasal J, Prasad B, Eikelboom J, Tennankore K, Rigatto C, Prce I, Madore F, Mac-Way F, Steele A, Zeng Y, Sholzberg M, Dorian P, Yan AT, Sood MM, Gladstone DJ, Tseng E, Kitchlu A, Walsh M, Sapir D, Oliver MJ, Krishnan M, Kiaii M, Wong N, Kotwal S, Battistella M, Acedillo R, Lok C, Weir M, Wald R. Anticoagulation for Patients with Atrial Fibrillation Receiving Dialysis: A Pilot Randomized Controlled Trial. J Am Soc Nephrol. 2025 May 1;36(5):901-910. doi: 10.1681/ASN.0000000000000495. Epub 2024 Nov 4.

    PubMed 39495569

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Warfarin, Apixaban and No oral anticoagulation in people with Atrial Fibrillation and End Stage Renal Failure on Dialysis, run by Unity Health Toronto at 28 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment of the target population within 2 years (time frame: 2 years from start of trial). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03987711, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in