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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 (VASC-UC)

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ClinicalTrials.gov Identifier: NCT04743518
Recruitment Status : Recruiting
First Posted : February 8, 2021
Last Update Posted : July 9, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Other: Aortic pulse wave velocity Other: carotid intima media thickness (CIMT) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Anti-TNF, Vedolizumab and Tofacitinib on Aortic Stiffness, Carotid Intima-media Thickness and Cardiovascular Risk of Patients With Ulcerative Colitis
Actual Study Start Date : February 2, 2021
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: anti-TNF Other: Aortic pulse wave velocity
Aortic pulse wave velocity (aPWV) is a measure of aortic stiffness

Other: carotid intima media thickness (CIMT)
carotid intima media thickness (CIMT)
Active Comparator: vedolizumab Other: Aortic pulse wave velocity
Aortic pulse wave velocity (aPWV) is a measure of aortic stiffness

Other: carotid intima media thickness (CIMT)
carotid intima media thickness (CIMT)
Active Comparator: tofacitinib Other: Aortic pulse wave velocity
Aortic pulse wave velocity (aPWV) is a measure of aortic stiffness

Other: carotid intima media thickness (CIMT)
carotid intima media thickness (CIMT)


Outcome Measures
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Primary Outcome Measures :
  1. variation of carotid intima media thickness (CIMT) between the 3 patient groups [ Time Frame: at the end of month 3 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ulcerative colitis evolving for at least 6 months,
  • Patient older than 18 years,
  • Initiating a treatment by infliximab, adalimumab, golimumab, vedolizumab or tofacitinib,
  • Written informed consent.

Exclusion Criteria:

  • Patients with anti-hypertensive, antiplatelet or lipid-lowering drugs without stable dosage within the 3 months before the study and over the study period,
  • Patients with a cardiovascular event such as myocardial infarction and stroke,
  • Diabetic patient,
  • Pregnant women,
  • Minor
  • people unable to give their consent to participate
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04743518


Contacts
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Contact: Mathurin Fumery, Pr 03 22 08 88 51 Fumery.mathurin@chu-amiens.fr

Locations
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France
CHU Amiens Recruiting
Amiens, France, 80480
Contact: Mathurin Fumery, Pr    03 22 08 88 51    Fumery.mathurin@chu-amiens.fr   
Sub-Investigator: Marie-Antoinette Sevestre, Pr         
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
More Information
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT04743518    
Other Study ID Numbers: PI2020_843_0114
First Posted: February 8, 2021    Key Record Dates
Last Update Posted: July 9, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire, Amiens:
ulcerative colitis
cardiovascular risk
CIMT
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases