← Back to Search

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

LIMIT 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.Check my eligibility

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.See study design

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.

LIMIT Trial 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.

LIMIT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an expected mean of 2-3 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Major bleeding

Thrombosis/thromboembolism

Secondary outcome measures

All cause mortality

All clinically important bleeding

All stroke

+11 more

Side effects data

From 2016 Phase 3 trial • 2199 Patients • NCT02072434

Atrial fibrillation

International normalised ratio increased

Cardiac failure

100%

80%

60%

40%

20%

Study treatment Arm

Warfarin

Edoxaban

LIMIT 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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Population Health Research InstituteLead Sponsor

155 Previous Clinical Trials

677,287 Total Patients Enrolled

4 Trials studying Bleeding

3,918 Patients Enrolled for Bleeding

Hamilton Health Sciences CorporationOTHER

368 Previous Clinical Trials

298,376 Total Patients Enrolled

3 Trials studying Bleeding

1,060 Patients Enrolled for Bleeding

Emilie Belley-Côté, MD, MScPrincipal InvestigatorMcMaster University

Media Library

Warfarin (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT03636295 — Phase 3

Bleeding Research Study Groups: Standard INR Target, Reduced INR Target

Bleeding 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

Frequently Asked Questions

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

What afflictions does Warfarin help to mitigate?

"Warfarin is a medication used to prevent the formation of clots. It is most often given to patients who have previously had thromboembolism, but it can also be prophylactic for those with venous thrombosis, cerebrovascular accident, and mechanical heart valve."

Answered by AI

Are people currently signing up to participate in this trial?

"This study, which was first made public on September 5th 2019, is currently looking for participants according to the website clinicaltrials.gov. The date of the most recent update was October 18th 2022."

Answered by AI

Has Warfarin been given the green light by the FDA?

"Since Warfarin is a Phase 3 drug, there is some data supporting its efficacy and multiple rounds of data supporting its safety, so our team at Power gives it a score of 3 for safety."

Answered by AI

How many individuals are included in this clinical trial?

"That is correct, the listing on clinicaltrials.gov says that this study is currently looking for participants. The original posting date was September 5th, 2019 and it was last updated on October 18th, 2022. They are enrolling 400 individuals total from 3 different sites."

Answered by AI

Could you list any other research studies that have used Warfarin as an experimental drug?

"At the moment, there are 29 studies underway regarding Warfarin. 9 of those live studies are currently in Phase 3. Although the majority of trials for Warfarin take place in Montreal, Quebec, there are actually 387 locations running these sorts of tests."

Answered by AI

Recent research and studies

The Journal of Thoracic and Cardiovascular SurgeryJournal

Reduced Anticoagulation After Mechanical Aortic Valve Replacement: Interim Results from the Prospective Randomized On-x Valve Anticoagulation Clinical Trial Randomized Food and Drug Administration Investigational Device Exemption Trial

Puskas, John, Marc Gerdisch, Dennis Nichols, Reed Quinn, Charles Anderson, Birger Rhenman, Lilibeth Fermin, et al.. 2014. “Reduced Anticoagulation After Mechanical Aortic Valve Replacement: Interim Results from the Prospective Randomized On-x Valve Anticoagulation Clinical Trial Randomized Food and Drug Administration Investigational Device Exemption Trial”. The Journal of Thoracic and Cardiovascular Surgery. Elsevier BV. doi:10.1016/j.jtcvs.2014.01.004.

clinicaltrials.govStudy

Low INR to Minimize Bleeding With Mechanical Valves Trial

Emilie Belley-Cote 2019. "Low INR to Minimize Bleeding With Mechanical Valves Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03636295.