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Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes

Study acronym: VA-IMPACT
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 2 wordsv49 See this version in full on ClinicalTrials.gov ↗
  2. Primary and study completion dates: Mar 31, 2029 to Sep 28, 2029 Site details revised at 3 of 40 sitesv48 Show 1 more changeShow less
    • Site details revised at 3 of 40 sites
  3. Study description revisedv47 See this version in full on ClinicalTrials.gov ↗
  4. Site details revised at 2 of 40 sitesv46
  5. Study description revisedv45 See this version in full on ClinicalTrials.gov ↗
Show 43 earlier versionsHide 43 earlier versions
  1. Site details revised at 1 of 40 sitesv44
  2. Site details revised at 1 of 40 sitesv43
  3. Site details revised at 1 of 40 sitesv42
  4. Site details revised at 1 of 40 sitesv41
  5. Site details revised at 1 of 40 sitesv40
  6. Site details revised at 1 of 40 sitesv39
  7. Site details revised at 1 of 40 sitesv38
  8. Site details revised at 1 of 40 sitesv37
  9. Site details revised at 3 of 40 sitesv36
  10. Site details revised at 1 of 40 sitesv35
  11. Site details revised at 1 of 40 sitesv34
  12. Site details revised at 34 of 40 sitesv33
  13. Trial status: Not Yet Recruiting to Recruiting Site details revised at 40 of 40 sitesv32 Show 1 more changeShow less
    • Site details revised at 40 of 40 sites
  14. Start date: Jan 1, 2023 to Apr 3, 2023 Primary and study completion dates: Dec 31, 2028 to Mar 31, 2029v31 Show 1 more changeShow less
    • Primary and study completion dates: Dec 31, 2028 to Mar 31, 2029
  15. Start date: Oct 1, 2022 to Jan 1, 2023 Primary and study completion dates: Sep 30, 2028 to Dec 31, 2028v30 Show 1 more changeShow less
    • Primary and study completion dates: Sep 30, 2028 to Dec 31, 2028
  16. Eligibility criteria shortened, about 314 words Site contacts updated at 1 of 40 sites · Study description shortened, about 1 wordv29 Show 2 more changesShow less
    • Site contacts updated at 1 of 40 sites
    • Study description shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  17. Primary and study completion dates: Aug 21, 2024 to Sep 30, 2028 Start date: Feb 21, 2019 to Oct 1, 2022 · Trial status: Active, Not Recruiting to Not Yet Recruiting · Enrollment target: 7868 to 7410 · 4 morev28 Show 7 more changesShow less
    • Start date: Feb 21, 2019 to Oct 1, 2022
    • Trial status: Active, Not Recruiting to Not Yet Recruiting
    • Enrollment target: 7868 to 7410
    • Study sites: 11 to 40
    • Eligibility criteria expanded, about 33 words
    • Secondary endpoints: details revised at 1 of 3 entries
    • Study description shortened, about 19 words

    See this version in full on ClinicalTrials.gov ↗

  18. 2 versions Re-verified since May 10, 2021, no change to tracked fieldsv26-v27
  19. Study Status, Referencesv25
  20. Trial status: Recruiting to Active, Not Recruiting Site details revised at 11 of 11 sitesv24 Show 1 more changeShow less
    • Site details revised at 11 of 11 sites
  21. Study description expanded, about 44 wordsv23 See this version in full on ClinicalTrials.gov ↗
  22. Re-verified, no change to tracked fieldsv22
  23. Site contacts updated at 1 of 11 sitesv21
  24. Secondary endpoints: details revised at 3 of 3 entriesv20
  25. Site details revised at 2 of 11 sitesv19
  26. Site details revised at 1 of 11 sitesv18
  27. Trial status: Not Yet Recruiting to Recruiting Primary and study completion dates: Aug 19, 2024 to Aug 21, 2024 · Start date changed from estimate of Feb 19, 2019 to Feb 21, 2019 · Site details revised at 11 of 11 sitesv17 Show 3 more changesShow less
    • Primary and study completion dates: Aug 19, 2024 to Aug 21, 2024
    • Start date changed from estimate of Feb 19, 2019 to Feb 21, 2019
    • Site details revised at 11 of 11 sites
  28. Primary and study completion dates: Aug 15, 2024 to Aug 19, 2024 Start date: Feb 15, 2019 to Feb 19, 2019v16 Show 1 more changeShow less
    • Start date: Feb 15, 2019 to Feb 19, 2019
  29. Start date: Jan 15, 2019 to Feb 15, 2019 Primary and study completion dates: Jul 15, 2024 to Aug 15, 2024v15 Show 1 more changeShow less
    • Primary and study completion dates: Jul 15, 2024 to Aug 15, 2024
  30. Primary and study completion dates: Jun 30, 2024 to Jul 15, 2024 Start date: Jan 2, 2019 to Jan 15, 2019v14 Show 1 more changeShow less
    • Start date: Jan 2, 2019 to Jan 15, 2019
  31. Start date: Dec 3, 2018 to Jan 2, 2019 Primary and study completion dates: May 31, 2024 to Jun 30, 2024v13 Show 1 more changeShow less
    • Primary and study completion dates: May 31, 2024 to Jun 30, 2024
  32. Start date: Nov 1, 2018 to Dec 3, 2018 Primary and study completion dates: Apr 30, 2024 to May 31, 2024v12 Show 1 more changeShow less
    • Primary and study completion dates: Apr 30, 2024 to May 31, 2024
  33. Primary and study completion dates: Apr 15, 2024 to Apr 30, 2024 Start date: Oct 15, 2018 to Nov 1, 2018v11 Show 1 more changeShow less
    • Start date: Oct 15, 2018 to Nov 1, 2018
  34. Start date: Sep 1, 2018 to Oct 15, 2018 Primary and study completion dates: Feb 29, 2024 to Apr 15, 2024v10 Show 1 more changeShow less
    • Primary and study completion dates: Feb 29, 2024 to Apr 15, 2024
  35. Eligibility criteria expanded, about 42 words Study sites revised (11)v9 Show 1 more changeShow less
    • Study sites revised (11)

    See this version in full on ClinicalTrials.gov ↗

  36. Start date: Aug 1, 2018 to Sep 1, 2018 Primary and study completion dates: Jan 31, 2024 to Feb 29, 2024v8 Show 1 more changeShow less
    • Primary and study completion dates: Jan 31, 2024 to Feb 29, 2024
  37. Start date: Jun 1, 2018 to Aug 1, 2018 Primary and study completion dates: Nov 30, 2024 to Jan 31, 2024v7 Show 1 more changeShow less
    • Primary and study completion dates: Nov 30, 2024 to Jan 31, 2024
  38. Start date: Jan 2, 2018 to Jun 1, 2018 Primary and study completion dates: Jun 30, 2024 to Nov 30, 2024v6 Show 1 more changeShow less
    • Primary and study completion dates: Jun 30, 2024 to Nov 30, 2024
  39. Primary completion date: Mar 31, 2023 to Jun 30, 2024 Start date: Oct 1, 2017 to Jan 2, 2018 · Completion date: Mar 31, 2024 to Jun 30, 2024 · Eligibility criteria shortened, about 110 words · 1 morev5 Show 4 more changesShow less
    • Start date: Oct 1, 2017 to Jan 2, 2018
    • Completion date: Mar 31, 2024 to Jun 30, 2024
    • Eligibility criteria shortened, about 110 words
    • Site contacts updated at 1 of 11 sites

    See this version in full on ClinicalTrials.gov ↗

  40. Start date: May 2017 to Oct 1, 2017 Primary completion date: Oct 2023 to Mar 31, 2023 · Completion date: Oct 2023 to Mar 31, 2024 · Site contacts updated at 3 of 11 sitesv4 Show 3 more changesShow less
    • Primary completion date: Oct 2023 to Mar 31, 2023
    • Completion date: Oct 2023 to Mar 31, 2024
    • Site contacts updated at 3 of 11 sites
  41. Site contacts updated at 7 of 11 sitesv3
  42. Study sites: 1 to 11v2
  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 research will help us to learn if the medicine called metformin reduces the risk of death, heart attacks, and/or strokes in Veterans who have pre-diabetes and heart or blood vessel problems.
Trial Details
NCT Number NCT02915198
Lead Sponsor VA Office of Research and Development
Conditions Prediabetic State, Atherosclerosis, Metformin
Enrollment 7,410 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov