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Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk

Study acronym: LEADER-PAD
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 70 → 86 locations Eligibility criteria expanded, about 12 words · Secondary endpoints: details revised at 5 of 14 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 5 of 14 entries
  2. Study sites: 59 to 70v7
  3. Study sites: 14 to 59 Secondary endpoints revised (14)v6 Show 1 more changeShow less
    • Secondary endpoints revised (14)

    See this version in full on ClinicalTrials.gov ↗

  4. Primary and study completion dates: Apr 2029 to Dec 2029 Study sites: 4 to 14v5 Show 1 more changeShow less
    • Study sites: 4 to 14
  5. Enrollment target: 150 to 6150 Primary completion date: Mar 2024 to Apr 2029 · Primary endpoint revised · Study sites: 3 to 4 · 4 morev4 Show 7 more changesShow less
    • Primary completion date: Mar 2024 to Apr 2029
    • Primary endpoint revised
    • Study sites: 3 to 4
    • Completion date: Sep 2024 to Apr 2029
    • Eligibility criteria expanded, about 25 words
    • Secondary endpoints: 3 to 14
    • Study description expanded, about 8 words

    See this version in full on ClinicalTrials.gov ↗

Show 2 earlier versionsHide 2 earlier versions
  1. Primary completion date: Mar 2023 to Mar 2024 Study sites: 1 to 3 · Completion date: Sep 2023 to Sep 2024v3 Show 2 more changesShow less
    • Study sites: 1 to 3
    • Completion date: Sep 2023 to Sep 2024
  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Mar 2021 to May 6, 2021 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Mar 2021 to May 6, 2021
    • Site details revised
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The Low dose ColchicinE in pAtients with peripheral Artery DiseasE to address residual vascular Risk (LEADER-PAD) trial will evaluate if anti-inflammatory therapy with colchicine will reduce vascular events in patients with symptomatic peripheral artery disease.
Trial Details
NCT Number NCT04774159
Lead Sponsor Population Health Research Institute
Conditions Peripheral Arterial Disease, Atherosclerosis of Extremities, Inflammation
Enrollment 6,150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov