Takayasu ArteritisTAK-CV-2026NCT07686991
Cardiovascular Risk in Patients With Takayasu Arteritis: A Nationwide Population-Based Cohort Study
An observational study of Takayasu Arteritis and Cardiovascular Diseases, run by Groupe français d'étude des Maladies Inflammatoires de loeil at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Takayasu Arteritis, Cardiovascular Diseases
- How many people
- 8,275 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jan 2010to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
APHP_ Hôpital Pitié-Salpêtrière
Paris
APHP_ Hôpital Saint-Antoine
Paris
About this study
Official title: Major Adverse Cardiovascular Events and Territory-Specific Arterial Complications in Patients With Takayasu Arteritis Compared With Matched General-Population Controls: A Nationwide Cohort Study Using the French SNDS
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).
Read the detailed description
Study Design and Data Source This is a retrospective nationwide cohort study using the SNDS database covering approximately 99% of the French population. All patients aged 15 to 60 years with an incident hospital diagnosis of Takayasu arteritis (ICD-10 M31.4, recorded as a principal, related, or associated diagnosis; validated algorithm with positive predictive value 93.9%) between 2010 and 2024 were identified and matched without replacement to up to four general-population controls Statistical Analysis Cumulative incidence was estimated as one minus the Kaplan-Meier estimate, with 95% confidence intervals. Hazard ratios comparing patients with Takayasu arteritis to matched controls were estimated from Cox proportional-hazards models stratified on the matched set. For non-fatal outcomes, competing-risk analyses treating death as a competing event were performed (Fine-Gray subdistribution hazard ratios and Aalen-Johansen cumulative incidence functions). Within the Takayasu arteritis cohort, cumulative prednisone-equivalent glucocorticoid dose was modelled as a time-dependent covariate in multivariable Cox models adjusted for cardiovascular and disease-related factors.
Outcomes The primary outcome was the first major adverse cardiovascular event (MACE), a composite of coronary event (myocardial infarction or unstable angina), ischemic stroke, or all-cause death. Secondary outcomes included the individual MACE components and territory-specific arterial events: aortic events, visceral artery events, and major adverse limb events.
Regulatory Compliance This study was conducted using the SNDS through the permanent access granted to Assistance Publique - Hôpitaux de Paris (AP-HP), in accordance with French Decree No. 2016-1871 and French Public Health Code (Art. R. 1461-13 and 14). The study was registered in the AP-HP internal registry of research projects before initiation. In compliance with the GDPR and French regulations, individual informed consent was not required as all data were fully anonymized
- Conditions
- Takayasu Arteritis, Cardiovascular Diseases
- Keywords
- Takayasu Arteritis, MACE, Inflammation, Atherosclerosis, Cardiovascular risk
- Medical subject headings
- Takayasu Arteritis, Cardiovascular Diseases, Inflammation, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events (MACE)
Major Adverse Cardiovascular Events (MACE) Composite of myocardial infarction, ischemic stroke, or all-cause death
Measured: Up to 15 years (January 2010 to December 2024)
Secondary outcomes (6)
Coronary events
Coronary events (myocardial infarction or unstable angina)
Measured: Time Frame: Up to 15 years (2010-2024)
Ischemic stroke
Ischemic stroke
Measured: Time Frame: Up to 15 years (2010-2024)
All-cause mortality
All-cause mortality
Measured: Time Frame: Up to 15 years (2010-2024)
Aortic events
Aortic events (aortic dissection or aneurysm, or thoracic/abdominal aortic surgical or endovascular procedure) Time Frame: Up to 15 years (2010-2024)
Measured: Up to 15 years (2010-2024)
Visceral artery events
Visceral artery events (digestive or renal artery dissection, aneurysm, or revascularization)
Measured: Up to 15 years (2010-2024)
Major adverse limb events
Major adverse limb events (lower-limb revascularization or major amputation)
Measured: Up to 15 years (2010-2024)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Jan 2010
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Takayasu ArteritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 8,275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe français d'étude des Maladies Inflammatoires de loeil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexis Guedon, Principal investigator, APHP - HOPITAL SAINT ANTOINE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07686991
- Sponsor's protocol ID
- TAK-CV-2026
- Acronym
- TAK-CV-2026
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28756037Scailteux 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.
PubMed 30392702Guedon 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.
PubMed 41537566
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Major Adverse Cardiovascular Events and Territory-Specific Arterial Complications in Patients With Takayasu Arteritis Compared With Matched General-Population Controls: A Nationwide Cohort Study Using the French SNDS
- ClinicalTrials.gov ID
- NCT07686991
- Acronym / sponsor ID
- TAK-CV-2026 / TAK-CV-2026
- Conditions
- Takayasu Arteritis, Cardiovascular Diseases
- Keywords
- Takayasu Arteritis, MACE, Inflammation, Atherosclerosis, Cardiovascular risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,275 participants (actual)
- Lead sponsor
- Groupe français d'étude des Maladies Inflammatoires de loeilUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Study Design and Data Source This is a retrospective nationwide cohort study using the SNDS database covering approximately 99% of the French population. All patients aged 15 to 60 years with an incident hospital diagnosis of Takayasu arteritis (ICD-10 M31.4, recorded as a principal, related, or associated diagnosis; validated algorithm with positive predictive value 93.9%) between 2010 and 2024 were identified and matched without replacement to up to four general-population controls Statistical Analysis Cumulative incidence was estimated as one minus the Kaplan-Meier estimate, with 95% confidence intervals. Hazard ratios comparing patients with Takayasu arteritis to matched controls were estimated from Cox proportional-hazards models stratified on the matched set. For non-fatal outcomes, competing-risk analyses treating death as a competing event were performed (Fine-Gray subdistribution hazard ratios and Aalen-Johansen cumulative incidence functions). Within the Takayasu arteritis cohort, cumulative prednisone-equivalent glucocorticoid dose was modelled as a time-dependent covariate in multivariable Cox models adjusted for cardiovascular and disease-related factors.
Outcomes The primary outcome was the first major adverse cardiovascular event (MACE), a composite of coronary event (myocardial infarction or unstable angina), ischemic stroke, or all-cause death. Secondary outcomes included the individual MACE components and territory-specific arterial events: aortic events, visceral artery events, and major adverse limb events.
Regulatory Compliance This study was conducted using the SNDS through the permanent access granted to Assistance Publique - Hôpitaux de Paris (AP-HP), in accordance with French Decree No. 2016-1871 and French Public Health Code (Art. R. 1461-13 and 14). The study was registered in the AP-HP internal registry of research projects before initiation. In compliance with the GDPR and French regulations, individual informed consent was not required as all data were fully anonymized
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major Adverse Cardiovascular Events (MACE)
Time frame: Up to 15 years (January 2010 to December 2024)
Major Adverse Cardiovascular Events (MACE) Composite of myocardial infarction, ischemic stroke, or all-cause death
6 secondary outcomes
Coronary events
Time frame: Time Frame: Up to 15 years (2010-2024)
Ischemic stroke
Time frame: Time Frame: Up to 15 years (2010-2024)
All-cause mortality
Time frame: Time Frame: Up to 15 years (2010-2024)
Aortic events
Time frame: Up to 15 years (2010-2024)
Visceral artery events
Time frame: Up to 15 years (2010-2024)
Major adverse limb events
Time frame: Up to 15 years (2010-2024)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Background: PubMed 28756037Tuppin 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.
- Background: PubMed 30392702Scailteux 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.
- Background: PubMed 41537566Guedon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexis Guedon principal investigator
APHP - HOPITAL SAINT ANTOINE
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Takayasu Arteritis and Cardiovascular Diseases, run by Groupe français d'étude des Maladies Inflammatoires de loeil at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Events (MACE) (time frame: Up to 15 years (January 2010 to December 2024)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07686991, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.