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Low INR to Minimize Bleeding With Mechanical Valves Trial

Study acronym: LIMIT
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Dec 31, 2026 → Dec 31, 2028
See other at-risk trials from Population Health Research Institute

Record History

  1. Primary and study completion pushed from Dec 31, 2026 to Dec 31, 2028 Primary endpoints: details revised at 1 of 2 entries · Trial sites expanded: 35 → 45 locations · Eligibility criteria expanded, about 6 words · 2 more Show 5 more changesShow less
    • Primary endpoints: details revised at 1 of 2 entries
    • Trial sites expanded: 35 → 45 locations
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 3 of 14 entries
    • Publications: details revised at 2 of 2 entries
  2. Study sites: 30 to 35v15
  3. Study sites: 26 to 30v14
  4. Study sites: 19 to 26v13
  5. Study sites: 18 to 19v12
Show 10 earlier versionsHide 10 earlier versions
  1. Primary completion date: Mar 31, 2025 to Dec 31, 2026 Study sites: 12 to 18 · Completion date: Dec 30, 2026 to Dec 31, 2026v11 Show 2 more changesShow less
    • Study sites: 12 to 18
    • Completion date: Dec 30, 2026 to Dec 31, 2026
  2. Study sites: 7 to 12v10
  3. Study sites: 6 to 7 Completion date: Apr 30, 2026 to Dec 30, 2026 · Secondary endpoints: details revised at 1 of 14 entries · Eligibility criteria shortened, about 2 wordsv9 Show 3 more changesShow less
    • Completion date: Apr 30, 2026 to Dec 30, 2026
    • Secondary endpoints: details revised at 1 of 14 entries
    • Eligibility criteria shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  4. Enrollment target: 400 to 2625v8
  5. Primary endpoints: 1 to 2 Study sites: 4 to 6 · Primary completion date: Mar 2025 to Mar 31, 2025 · Completion date: Mar 2025 to Apr 30, 2026 · 3 morev7 Show 6 more changesShow less
    • Study sites: 4 to 6
    • Primary completion date: Mar 2025 to Mar 31, 2025
    • Completion date: Mar 2025 to Apr 30, 2026
    • Secondary endpoints: 6 to 14
    • Eligibility criteria expanded, about 2 words
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  6. Primary and study completion dates: Sep 2022 to Mar 2025v6
  7. Enrollment target: 200 to 400 Eligibility criteria expanded, about 11 words · Secondary endpoints reorderedv5 Show 2 more changesShow less
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints reordered

    See this version in full on ClinicalTrials.gov ↗

  8. Lead sponsor: McMaster University to Population Health Research Institute Study sites: 1 to 4 · Collaborators expanded, about 4 wordsv4 Show 2 more changesShow less
    • Study sites: 1 to 4
    • Collaborators expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  9. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Primary and study completion dates: Aug 2022 to Sep 2022 · Start date changed from estimate of Aug 2019 to Sep 5, 2019v3 Show 3 more changesShow less
    • Study sites: 0 to 1
    • Primary and study completion dates: Aug 2022 to Sep 2022
    • Start date changed from estimate of Aug 2019 to Sep 5, 2019
  10. Primary and study completion dates: Dec 2021 to Aug 2022 Start date: Sep 2018 to Aug 2019 · Secondary endpoints: 4 to 6v2 Show 2 more changesShow less
    • Start date: Sep 2018 to Aug 2019
    • Secondary endpoints: 4 to 6

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov