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Anticoagulant

Warfarin for Atrial Fibrillation (SAFE-D Trial)

Phase 2
Waitlist Available
Led By Ron Wald
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years from start of trial
Awards & highlights

SAFE-D Trial Summary

This trial is looking at whether or not anticoagulation is effective in reducing the risk of stroke or systemic embolism in patients with atrial fibrillation receiving dialysis.

Eligible Conditions
  • Atrial Fibrillation
  • Kidney Disease

SAFE-D Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years from start of trial
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years from start of trial for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.
Recruitment of the target population within 2 years
Secondary outcome measures
>95% of randomized patients adhere to the enrollment criteria with respect to atrial fibrillation or atrial flutter
All cause mortality
Clinically relevant non-major bleeding
+6 more

Side effects data

From 2016 Phase 3 trial • 2199 Patients • NCT02072434
5%
Atrial fibrillation
1%
International normalised ratio increased
1%
Cardiac failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Warfarin
Edoxaban

SAFE-D Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: WarfarinExperimental Treatment1 Intervention
Individuals randomized to this arm will be exposed to dose-adjusted daily warfarin targeting an international normalized ratio (INR) of 2.0-3.0.
Group II: ApixabanActive Control1 Intervention
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).
Group III: No oral anticoagulationActive Control1 Intervention
Individuals in this arm will be exposed to a treatment strategy in which no oral anticoagulation is prescribed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Warfarin
2017
Completed Phase 4
~248220

Find a Location

Who is running the clinical trial?

The George Institute for Global Health (Sydney, Australia)UNKNOWN
Unity Health TorontoLead Sponsor
537 Previous Clinical Trials
447,388 Total Patients Enrolled
3 Trials studying Atrial Fibrillation
558 Patients Enrolled for Atrial Fibrillation
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,343 Previous Clinical Trials
26,452,942 Total Patients Enrolled
20 Trials studying Atrial Fibrillation
649,770 Patients Enrolled for Atrial Fibrillation

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Warfarin been cleared by the FDA?

"Warfarin's Phase 2 status means that while there is some evidence of safety, researchers have not yet seen data supporting efficacy."

Answered by AI

How many people have been recruited for this experiment?

"Unfortunately, this particular trial is no longer looking for new patients. The listing was created on December 10th, 2019 and updated for the last time on September 26th, 2022. For reference, there are 689 trials related to atrial fibrillation and 69 studies investigating Warfarin that are actively recruiting participants."

Answered by AI

Can people currently enroll in this research project?

"According to the clinicaltrials.gov website, this trial is not currently recruiting patients. The listing was created on December 10th, 2019 and last edited September 26th, 2020. Although this study isn't taking any more participants, there are 758 other trials that are presently looking for candidates."

Answered by AI

What are some of the common conditions that Warfarin helps to manage?

"Warfarin is used to treat deep vein thrombosis. It can also be used as a prophylactic measure for cerebrovascular accident, systemic embolism, and myocardial infarction."

Answered by AI

What other patient populations have been studied with Warfarin?

"Warfarin's first clinical trials were completed in 2013 at Ain Shams University hospitals. Since then, a total of 311 studies have been conducted. As of right now, 69 separate research projects are ongoing with many taking place in Thunder Bay, Ontario."

Answered by AI

How many hospitals are running this trial?

"There are 24 locations where this trial is available, such as Thunder Bay Regional Health Sciences Centre in Thunder Bay, Hôpital Maisonneuve-Rosemont in Ottawa, and The Ottawa Hospital - Riverside Campus in Sudbury."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Strategies for the Management of Atrial Fibrillation in patiEnts Receiving Dialysis
2019. "Strategies for the Management of Atrial Fibrillation in patiEnts Receiving Dialysis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03987711.
~28 spots leftby Apr 2025
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