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RIVACAST - RIVAroxaban versus low-molecular weight heparin in patients with lower limb trauma requiring brace or CASTing

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509905-62-00
Acronym
49RC21_0376
Enrollment
1424
Registered
2024-04-12
Start date
2024-07-19
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower limb trauma requiring immobilisation

Brief summary

The primary endpoint is the rate of symptomatic venous thromboembolic events (i.e., deep venous thrombosis and/or pulmonary embolism and/or death due to pulmonary embolism) within the 45 days after the inclusion

Interventions

DRUGFRAGMINE 5 000 U.l. anti Xa/0
DRUG2 mL
DRUG45 ml
DRUGFRAXIPARINE 3 800 U.I. Axa/0
DRUG4 ml
DRUGsolution injectable (S.C.) en seringue pré-remplie
DRUGFRAXIPARINE 5 700 U.I. Axa/0
DRUG6 ml
DRUGFRAGMINE 2 500 U.l. anti Xa/0

Sponsors

Centre Hospitalier Universitaire D'Angers
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the rate of symptomatic venous thromboembolic events (i.e., deep venous thrombosis and/or pulmonary embolism and/or death due to pulmonary embolism) within the 45 days after the inclusion

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026