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Ataciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis: A Randomized, Placebo Controlled Study

Study acronym: KATALYST-AV
StatusRecruiting
PhasePhase 2/3
Started
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Record History

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  1. Trial sites expanded: 70 → 74 locationsv11
  2. Eligibility criteria expanded, about 20 words
    • Secondary endpoints: 7 to 8
    • Site details revised at 2 of 70 sites
    v10
  3. Trial sites expanded: 58 → 70 locationsv9
  4. Study sites: 53 to 58v8
  5. Phase: Phase 3 to Phase 2/3v7 Show 7 more changesShow less
    • Primary endpoints revised (3)
    • Enrollment target: 1410 to 1276
    • Study sites: 47 to 53
    • Eligibility criteria expanded, about 85 words
    • Secondary endpoints revised (7)
    • Study description expanded, about 23 words
    • Study title expanded, about 1 word
Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 49 to 47v6
  2. Study sites: 50 to 49v5
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 17, 2025 to Jun 27, 2025
    • Site details revised at 50 of 50 sites
    v4
  4. Study sites: 0 to 50v3
  5. Secondary endpoints revised (7)
    • Primary endpoints revised (3)
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of this study is to evaluate if ataciguat slows the progression of moderate calcific aortic valve stenosis in adults.
Trial Details
NCT Number NCT07001800
Lead Sponsor Kardigan, Inc.
Conditions
(from sponsor)		 Moderate Aortic Valve Stenosis
Related terms Aortic Valve Stenosis
Enrollment 1,276 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov