NCT07686991

Brief Summary

This nationwide observational cohort study compares the risk of major adverse cardiovascular events (MACE) and territory-specific arterial complications between patients with incident Takayasu arteritis and matched general-population controls, and identifies determinants of MACE within the Takayasu arteritis population, including cumulative glucocorticoid exposure, using the French National Health Data System (SNDS).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,275

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
15 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 7, 2026

Completed
Last Updated

July 7, 2026

Status Verified

June 1, 2026

Enrollment Period

15 years

First QC Date

June 30, 2026

Last Update Submit

June 30, 2026

Conditions

Keywords

Takayasu ArteritisMACEInflammationAtherosclerosisCardiovascular risk

Outcome Measures

Primary Outcomes (1)

  • Major Adverse Cardiovascular Events (MACE)

    Major Adverse Cardiovascular Events (MACE) Composite of myocardial infarction, ischemic stroke, or all-cause death

    Up to 15 years (January 2010 to December 2024)

Secondary Outcomes (6)

  • Coronary events

    Time Frame: Up to 15 years (2010-2024)

  • Ischemic stroke

    Time Frame: Up to 15 years (2010-2024)

  • All-cause mortality

    Time Frame: Up to 15 years (2010-2024)

  • Aortic events

    Up to 15 years (2010-2024)

  • Visceral artery events

    Up to 15 years (2010-2024)

  • +1 more secondary outcomes

Study Arms (2)

Takayasu arteritis cohort

Patients aged 15 to 60 years with an incident hospital diagnosis of Takayasu arteritis (ICD-10 M31.4) recorded between 2010 and 2024 (n=1,655).

Matched general-population controls

General-population controls without Takayasu arteritis, matched 4:1 (exact on sex and region, calipers on year of birth and propensity-score logit), each inheriting the index date of the matched case (n=6,620).

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 15 to 60 years hospitalized for incident Takayasu arteritis in France identified from the SNDS database, together with up to four matched general-population controls per case.

You may qualify if:

  • Age 15 to 60 years Cases: incident hospital diagnosis of Takayasu arteritis (ICD-10 M31.4) recorded as principal, related, or associated diagnosis between 2010 and 2024 Cases matched 4:1 to general-population controls (exact on sex and region; calipers on year of birth and propensity-score logit) Controls: alive and active in the database at the index date (≥1 reimbursed contact in the prior 365 days), residing in the same region, with no recorded Takayasu arteritis diagnosis

You may not qualify if:

  • Cases who could not be matched to at least four eligible general-population controls Age outside the 15 to 60 years range at the index date

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

APHP_ Hôpital Pitié-Salpêtrière

Paris, France

Location

APHP_ Hôpital Saint-Antoine

Paris, France

Location

Related Publications (3)

  • Tuppin P, Rudant J, Constantinou P, Gastaldi-Menager C, Rachas A, de Roquefeuil L, Maura G, Caillol H, Tajahmady A, Coste J, Gissot C, Weill A, Fagot-Campagna A. Value of a national administrative database to guide public decisions: From the systeme national d'information interregimes de l'Assurance Maladie (SNIIRAM) to the systeme national des donnees de sante (SNDS) in France. Rev Epidemiol Sante Publique. 2017 Oct;65 Suppl 4:S149-S167. doi: 10.1016/j.respe.2017.05.004. Epub 2017 Jul 27.

    PMID: 28756037BACKGROUND
  • Scailteux LM, Droitcourt C, Balusson F, Nowak E, Kerbrat S, Dupuy A, Drezen E, Happe A, Oger E. French administrative health care database (SNDS): The value of its enrichment. Therapie. 2019 Apr;74(2):215-223. doi: 10.1016/j.therap.2018.09.072. Epub 2018 Oct 25.

    PMID: 30392702BACKGROUND
  • Guedon AF, Espitia O, Beydon M, Ghrenassia E, Mirault T, Messas E, Tubach F, Seror R, Boccara F, Cohen A, Frikke-Schmidt R, Nordestgaard BG, Dellal A, Fain O, Mekinian A, Carrat F. Cardiovascular risk among Giant cells arteritis patients. Eur J Prev Cardiol. 2026 Jan 14:zwag034. doi: 10.1093/eurjpc/zwag034. Online ahead of print.

    PMID: 41537566BACKGROUND

MeSH Terms

Conditions

Takayasu ArteritisCardiovascular DiseasesInflammationAtherosclerosis

Condition Hierarchy (Ancestors)

Aortic Arch SyndromesAortic DiseasesVascular DiseasesArteritisVasculitisSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Alexis Guedon

    APHP - HOPITAL SAINT ANTOINE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2026

First Posted

July 7, 2026

Study Start

January 1, 2010

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

July 7, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations