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Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events

Study acronym: V-PLAQUE
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment target: 609 to 610 Eligibility criteria expanded, about 11 words · Study description revised · Site details revised at 2 of 89 sites · 1 more Show 4 more changesShow less
    • Eligibility criteria expanded, about 11 words
    • Study description revised
    • Site details revised at 2 of 89 sites
    • Publications: details revised at 1 of 1 entry
  2. Enrollment target: 608 to 609v40
  3. Re-verified, no change to tracked fieldsv39
  4. Enrollment target: 610 to 608 Site details revised at 1 of 89 sitesv38 Show 1 more changeShow less
    • Site details revised at 1 of 89 sites
  5. 2 versions Re-verified since Mar 5, 2026, no change to tracked fieldsv36-v37
Show 34 earlier versionsHide 34 earlier versions
  1. Site details revised at 8 of 89 sitesv35
  2. Site details revised at 27 of 89 sitesv34
  3. Enrollment target: 608 to 610 Study sites: 91 to 89 · Primary and study completion dates: Jan 25, 2027 to Oct 26, 2026v33 Show 2 more changesShow less
    • Study sites: 91 to 89
    • Primary and study completion dates: Jan 25, 2027 to Oct 26, 2026
  4. Site details revised at 1 of 91 sitesv32
  5. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 600 to confirmed 608 · Study sites: 104 to 91v31 Show 2 more changesShow less
    • Enrollment target: estimated 600 to confirmed 608
    • Study sites: 104 to 91
  6. Study sites revised (104)v30 See this version in full on ClinicalTrials.gov ↗
  7. Study sites revised (104)v29 See this version in full on ClinicalTrials.gov ↗
  8. Study sites: 103 to 104 Primary completion date: Jan 7, 2027 to Jan 25, 2027 · Completion date: Jan 15, 2027 to Jan 25, 2027 · Eligibility criteria shortened, about 12 words · 1 morev28 Show 4 more changesShow less
    • Primary completion date: Jan 7, 2027 to Jan 25, 2027
    • Completion date: Jan 15, 2027 to Jan 25, 2027
    • Eligibility criteria shortened, about 12 words
    • Study description shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  9. Primary completion date: Jan 2, 2026 to Jan 7, 2027 Completion date: Jan 2, 2026 to Jan 15, 2027 · Study sites revised (103)v27 Show 2 more changesShow less
    • Completion date: Jan 2, 2026 to Jan 15, 2027
    • Study sites revised (103)

    See this version in full on ClinicalTrials.gov ↗

  10. Study sites: 101 to 103v26
  11. Study sites: 93 to 101v25
  12. Study sites: 87 to 93v24
  13. Study sites: 68 to 87 Primary and study completion dates: Jul 18, 2025 to Jan 2, 2026v23 Show 1 more changeShow less
    • Primary and study completion dates: Jul 18, 2025 to Jan 2, 2026
  14. Study sites: 58 to 68v22
  15. Study sites: 56 to 58v21
  16. Study sites: 55 to 56v20
  17. Study sites: 54 to 55v19
  18. Study sites: 50 to 54v18
  19. Study sites: 45 to 50v17
  20. Study sites: 43 to 45v16
  21. Study sites: 42 to 43v15
  22. Study sites: 40 to 42v14
  23. Study sites: 38 to 40v13
  24. Study sites: 34 to 38v12
  25. Study sites: 32 to 34v11
  26. Study sites: 30 to 32v10
  27. Study sites: 27 to 30v9
  28. Study sites: 25 to 27v8
  29. Study sites: 23 to 25v7
  30. Study sites: 22 to 23v6
  31. Study sites: 11 to 22v5
  32. Study sites: 10 to 11v4
  33. Study sites: 3 to 10 Primary and study completion dates: Jun 5, 2025 to Jul 18, 2025v3 Show 1 more changeShow less
    • Primary and study completion dates: Jun 5, 2025 to Jul 18, 2025
  34. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 3 · Start date changed from estimate of May 27, 2022 to Jul 8, 2022v2 Show 2 more changesShow less
    • Study sites: 0 to 3
    • Start date changed from estimate of May 27, 2022 to Jul 8, 2022
  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.
Novartis
555 trials monitored
See 31 trials at risk
Coronary Artery Disease
1,538 trials monitored
See 68 trials at risk
CKJX839D12303 is a research study to determine if the study treatment, called inclisiran, in comparison to placebo taken in addition to statin medication can effectively reduce the total amount of plaque formed in the heart's vessels as measured by coronary computed tomography angiography (CCTA) from baseline to month 24. This study is being conducted in eligible participants with a diagnosis of non-obstructive coronary artery disease (NOCAD), where the coronary arteries are blocked less than 50%, and with no previous cardiovascular events.
Trial Details
NCT Number NCT05360446
Lead Sponsor Novartis Pharmaceuticals
Conditions Coronary Artery Disease
Enrollment 610 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov