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Anticoagulant

Lower INR Warfarin for Mechanical Valve Patients (LIMIT Trial)

Phase 3
Recruiting
Led By Emilie Belley-Côté, MD, MSc
Research Sponsored by Population Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have had a bileaflet mechanical heart valve implant in the aortic position 3 or more months ago
Age is 18 or older at the time of enrolment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an expected mean of 2-3 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This triallooks at a lower INR target in patients with mechanical heart valves. It may reduce bleeding risk while minimizing stroke risk. Results may reduce need for lifelong warfarin treatment.

Who is the study for?
This trial is for adults over 18 who have had a bileaflet mechanical heart valve placed in the aortic position at least 3 months ago and can provide informed consent. It's not for those with multiple mechanical valves, pregnant individuals, or anyone using an On-X Valve.
What is being tested?
The study is testing if patients with mechanical heart valves can maintain a lower INR target (1.5 to 2.5) to reduce bleeding without increasing the risk of blood clots and stroke while on warfarin treatment.
What are the potential side effects?
Lowering the INR target may decrease bleeding risks but could potentially increase chances of developing blood clots or having a stroke; monitoring will be essential.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I had a mechanical heart valve replacement in the aortic position over 3 months ago.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an expected mean of 2-3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an expected mean of 2-3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Major bleeding
Thrombosis/thromboembolism
Secondary study objectives
All cause mortality
All clinically important bleeding
All stroke
+11 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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Reduced INR TargetExperimental Treatment1 Intervention
Warfarin therapy will be titrated to a target INR in the range of 1.5 to 2.5.
Group II: Standard INR TargetActive Control1 Intervention
Warfarin therapy will be titrated to a "standard of care" target INR range.
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?

Population Health Research InstituteLead Sponsor
164 Previous Clinical Trials
715,889 Total Patients Enrolled
Hamilton Health Sciences CorporationOTHER
377 Previous Clinical Trials
337,775 Total Patients Enrolled
Emilie Belley-Côté, MD, MScPrincipal InvestigatorMcMaster University

Media Library

Warfarin (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT03636295 — Phase 3
Blood Clot Research Study Groups: Standard INR Target, Reduced INR Target
Blood Clot Clinical Trial 2023: Warfarin Highlights & Side Effects. Trial Name: NCT03636295 — Phase 3
Warfarin (Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03636295 — Phase 3
~159 spots leftby Mar 2025
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