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Impact of Anti-TNF, Vedolizumab and Tofacitinib on Aortic Stiffness, Carotid Intima-media Thickness and Cardiovascular Risk of Patients With Ulcerative Colitis

Study acronym: VASC-UC
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 29, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Phase: Not applicable to Phase 4
    • Primary completion date: Dec 2023 to Dec 2025
    • Study completion date: Feb 2024 to Dec 2025
    v5
  2. Primary completion date: Feb 2023 to Dec 2023v4
  3. 2 versions Re-verified since Jul 8, 2021, no change to tracked fieldsv2-v3
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
An increased risk of cardiovascular (CV) diseases has been observed in patients with inflammatory bowel diseases (IBD). The impact of IBD drugs, such as anti-TNF, anti-integrins or anti-JAK, on the risk of CV events in IBD is remains unknown. Aortic pulse wave velocity (aPWV), a measure of aortic stiffness, and carotid intima media thickness (CIMT) are both predictors of cardiovascular events and are increased in patients with IBD. The investigators aimed to prospectively compare the CV risk, CIMT, arterial stiffness and biomarkers of endothelial dysfunction at baseline and after 3 and 12 months of anti-TNF, vedolizumab and tofacitinib.
Trial Details
NCT Number NCT04743518
Lead Sponsor Centre Hospitalier Universitaire, Amiens
Conditions
(from sponsor)		 Ulcerative Colitis
Related terms Colitis, Ulcerative
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov