Clinical Trial

Low INR to Minimize Bleeding With Mechanical Valves Trial

Study acronym: LIMIT
Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
This study evaluates the use of a lower INR target (1.5 to 2.5) in patients with a mechanical bileaflet heart valve in the aortic position. This study will inform physicians about whether a lower INR target will decrease the risk of bleeding or increase the risk of blood clot formation and stroke. These results have the potential to reduce the burden of bleeding in patients with a mechanical heart valve who require lifelong warfarin (Coumadin) treatment.
Protocol Amendment History 14 amendments
This ClinicalTrials.gov record has been amended 14 times since 2018-08-15; most recent amendment 2025-12-31.
Status change: Not Yet Recruiting → Recruiting 2019-11-08
Trial Details
NCT Number NCT03636295
Lead Sponsor Population Health Research Institute
Collaborators: Hamilton Health Sciences Corporation
Conditions Bleeding Post-mechanical Valve Replacement, Thromboembolism Post-mechanical Valve Replacement
Enrollment 2,625 participants
Start Date 2019-09-05
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-06