NCT03987711 (SAFE-D) is a Phase 2 clinical trial of Warfarin in Atrial Fibrillation, sponsored by Unity Health Toronto.

Who is sponsoring NCT03987711?

NCT03987711 is sponsored by Unity Health Toronto.

What drugs are being tested in NCT03987711?

Interventions in NCT03987711: Warfarin, Apixaban, No oral anticoagulation.

What condition does NCT03987711 study?

NCT03987711 studies Atrial Fibrillation, End Stage Renal Failure on Dialysis.

Is NCT03987711 still recruiting?

NCT03987711 is currently completed. Last updated 22 June 2023.

Last reviewed 2023-06-22 · How we verify

NCT03987711: SAFE-D

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Strategies for the Management of Atrial Fibrillation in patiEnts Receiving Dialysis

Completed Phase 2 Last updated 22 June 2023

What this trial tests

Phase 2 trial testing Warfarin in Atrial Fibrillation in 151 participants. Completed in 31 December 2022.

Timeline

10 December 2019

Primary endpoint
31 December 2022

31 December 2022

Quick facts

Lead sponsor	Unity Health Toronto
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	151
Start date	10 December 2019
Primary completion	31 December 2022
Estimated completion	31 December 2022
Sites	28 locations across Canada, Australia

Drugs / interventions tested

Warfarin (warfarin) — full drug profile →
Apixaban (apixaban) — full drug profile →
No oral anticoagulation — full drug profile →

Conditions studied

Atrial Fibrillation — all drugs for Atrial Fibrillation →
End Stage Renal Failure on Dialysis — all drugs for End Stage Renal Failure on Dialysis →

Sponsor

Unity Health Toronto — full company profile →

Who can join

18 and older, any sex, with Atrial Fibrillation or End Stage Renal Failure on Dialysis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

2021 European Heart Rhythm Association Practical Guide on the Use of Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial Fibrillation.
Steffel J, Collins R, Antz M, Cornu P, et al · · 2021 · cited 670× · PMID 33895845 · DOI 10.1093/europace/euab065
Safety and Efficacy of Vitamin K Antagonists versus Rivaroxaban in Hemodialysis Patients with Atrial Fibrillation: A Multicenter Randomized Controlled Trial.
De Vriese AS, Caluwé R, Caluwé R, Van Der Meersch H, et al · · 2021 · cited 125× · PMID 33753537 · DOI 10.1681/asn.2020111566
Atrial fibrillation and stroke prevention: 25 years of research at EP Europace journal.
Lip GYH, Proietti M, Potpara T, Mansour M, et al · · 2023 · cited 115× · PMID 37622590 · DOI 10.1093/europace/euad226
Apixaban versus No Anticoagulation in Patients Undergoing Long-Term Dialysis with Incident Atrial Fibrillation.
Mavrakanas TA, Mavrakanas TA, Garlo K, Charytan DM. · · 2020 · cited 66× · PMID 32444398 · DOI 10.2215/cjn.11650919
Anticoagulation in Patients with Chronic Kidney Disease.
Elenjickal EJ, Travlos CK, Marques P, Mavrakanas TA. · · 2024 · cited 22× · PMID 38035566 · DOI 10.1159/000535546
Direct oral anticoagulants for unusual-site venous thromboembolism.
Riva N, Ageno W. · · 2021 · cited 21× · PMID 33733025 · DOI 10.1002/rth2.12480
Stroke Prevention in Atrial Fibrillation: A Scientific Statement of <i>JACC: Asia</i> (Part 1).
Chiang CE, Chao TF, Choi EK, Lim TW, et al · · 2022 · cited 19× · PMID 36339361 · DOI 10.1016/j.jacasi.2022.05.005
Safety and Efficacy of DOACs in Patients with Advanced and End-Stage Renal Disease.
Rogula S, Gąsecka A, Mazurek T, Navarese EP, et al · · 2022 · cited 19× · PMID 35162472 · DOI 10.3390/ijerph19031436

Verify or expand the search:

Other trials of Warfarin

Trials testing the same drug.

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NCT07456085 — Rivaroxaban vs Warfarin in Patients With Mechanical Heart Valves · Phase 3 · enrolling by invitation
NCT07331389 — A Drug-Drug Interaction Study of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin · Phase 1 · recruiting
NCT05643651 — Rivaroxaban for Children Aged Over 2 Years With Giant Coronary Artery Aneurysms After Kawasaki Disease · Phase 4 · recruiting
NCT07358416 — Complications and Antiplatelet and Anticoagulant Therapy in Vascular Surgery. · active not recruiting

Other recruiting trials for Atrial Fibrillation

Currently open trials in the same condition.

NCT07429214 — A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF · NA · recruiting
NCT07271238 — Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures · NA · recruiting
NCT07388108 — Atrial Dyssynchrony to Predict Arrhythmias in the Postoperative Setting of Cardiovascular Surgery. · recruiting
NCT07428967 — AV Node Ablation and CONDUCTion System Pacing for Atrial Fibrillation With Preserved Left Ventricular Function · NA · recruiting
NCT06650995 — AlEX-DHF: Ablation and Exercise in Diastolic Heart Failure · NA · recruiting

Other Unity Health Toronto trials

Trials by the same sponsor.

NCT07507409 — Innovative Sternal Closure Techniques: Evaluating STRATAFIX™ and DERMABOND™ for Reduced Complications in CABG Patients · Phase 4 · not yet recruiting
NCT07455487 — First Appendectomy Using Revolve Surgical Robotic Arm · NA · not yet recruiting
NCT07301632 — Ecstasy to Alleviate SEvere Chronic Neuropathic Pain Trial · Phase 2 · recruiting
NCT07314905 — Adaptive Platform Trial of Treatments for Respiratory Infections in Community Settings (TreatResp) · Phase 3 · not yet recruiting
NCT06571916 — Brief Skills for Safer Living (Brief-SfSL) · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03987711 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Unity Health Toronto
Last refreshed: 22 June 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03987711.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing