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Anticoagulant

Dose reduction for Atrial Fibrillation (ADREL Trial)

Phase 2
Waitlist Available
Led By Vinai C. Bhagirath, MD MSc.
Research Sponsored by Hamilton Health Sciences Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with non-valvular atrial fibrillation (permanent, paroxysmal, or persistent) receiving apixaban with any of the following characteristics: age>85; creatinine clearance <40mL/min; or body weight <50kg.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week after dose reduction
Awards & highlights

ADREL Trial Summary

Apixaban is an anticoagulant which is increasingly being used to prevent stroke in atrial fibrillation (AF). Phase III clinical trials have demonstrated that apixaban is efficacious and safe for the overall AF population; however, patients older than age 85, with creatinine clearance <40mL/min, or who weighed <50kg were poorly represented in these trials, yet they are commonly seen in real-world clinical scenarios. Advanced age, poor renal function, and low body weight are all associated with elevated drug levels, and elevated drug levels are associated with an increased risk of bleeding. Therefore, clinicians are concerned about the risk of bleeding and are unsure of how best to treat this patient population. Although other anticoagulants are available, apixaban is attractive because it has a low rate of bleeding, low dependence on the kidneys for clearance, and does not require frequent ongoing monitoring and dose adjustment. This study will include patients taking apixaban who were not well-represented in phase III trials - those with age >85, creatinine clearance <40mL/min, or weight <50kg - who are also at increased risk of having elevated drug levels due to these clinical characteristics. Participants will have apixaban levels measured, and those with persistently elevated levels will have their dose reduced. Drug levels will be measured again after dose reduction to determine if the levels are reduced without becoming dangerously low.

ADREL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

ADREL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week after dose reduction
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week after dose reduction for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients who achieve target range
Secondary outcome measures
Proportion of patients who develop low levels after dose reduction
Proportion of patients who spontaneously develop levels below the median of the observed on-therapy range
Proportion of patients with persistently elevated levels

Side effects data

From 2018 Phase 4 trial • 557 Patients • NCT01884337
7%
Incision site pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
TOTAL KNEE REPLACEMENT (TKR)
TOTAL HIP REPLACEMENT (THR)

ADREL Trial Design

1Treatment groups
Experimental Treatment
Group I: Dose reductionExperimental Treatment1 Intervention
Eligible patients with apixaban levels persistently above 170ng/mL on two occasions, 2 weeks apart, will undergo apixaban dose reduction.

Find a Location

Who is running the clinical trial?

Hamilton Health Sciences CorporationLead Sponsor
368 Previous Clinical Trials
300,873 Total Patients Enrolled
11 Trials studying Atrial Fibrillation
13,167 Patients Enrolled for Atrial Fibrillation
Population Health Research InstituteOTHER
155 Previous Clinical Trials
679,792 Total Patients Enrolled
30 Trials studying Atrial Fibrillation
52,182 Patients Enrolled for Atrial Fibrillation
Vinai C. Bhagirath, MD MSc.Principal InvestigatorMcMaster University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~14 spots leftby Apr 2025