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NCT04363021: PREVASCLERO
Is a History of Pre-eclampsia a Risk Factor for Vascular Phenotype in Women With Systemic Sclerosis?
trial in Systemic Sclerosis in 378 participants. Completed in 31 May 2022.
31 May 2022
Quick facts
| Lead sponsor | University Hospital, Brest |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 378 |
| Start date | 6 July 2020 |
| Primary completion | 31 May 2022 |
| Estimated completion | 31 May 2022 |
| Sites | 10 locations across France |
Conditions studied
- Systemic Sclerosis — all drugs for Systemic Sclerosis →
- Preeclampsia — all drugs for Preeclampsia →
- Vascular Complications — all drugs for Vascular Complications →
Sponsor
University Hospital, Brest
Who can join
Adults 18 to 90, female only, with Systemic Sclerosis or Preeclampsia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: Pre-eclampsia, defined by the association of an arterial hypertension and significant proteinuria after 20 weeks of gestation, complicates 1 to 2% of pregnancies in France. Its pathophysiology involves angiogenesis impairment, upregulated maternal systemic inflammatory response, activation of oxidative stress and endothelial dysfunction. In a recent Danish nation-wide cohort study, pre-eclampsia was associated with a 69% increased risk of later developing scleroderma. Type of study: prospective observational case-control study. Primary objective of the study: to determine if a history of pre-eclampsia before systemic sclerosis diagnosis is an independent risk factor for vascular phenotype in sclerodermic women. Secondary objective: to describe all risk factors for vascular phenotype in sclerodermic women with a previous pregnancy longer than 6 months before scleroderma diagnosis.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04363021
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04363021 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Brest
- Last refreshed: 9 February 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04363021.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing