Lupus & antiphospholipid syndrome
Comparison of aspirin and rivaroxaban for the prevention of pulmonary embolism and deep vein thrombosis in high thrombotic risk patients with systemic lupus erythematosus: study protocol for a multicentre, prospective, randomised controlled trial
Study context
- Population
- Adults with systemic lupus erythematosus (SLE), persistently aPL-negative, at elevated thrombotic risk (D-dimer >2.0 µg/mL or SLE-VTE score ≥100)planned
- Participants
- 456 adults
- Planned comparison
- Rivaroxaban 10 mg once daily vs enteric-coated aspirin 100 mg once daily for 12 months
- Primary endpoint
- Time to first objectively confirmed venous thromboembolism (VTE) event
Methodological detailsmulticentre, prospective, open-label, 1:1 randomisation, Secondary outcomes: arterial thrombotic events, major bleeding, all-cause mortality, longitudinal changes in disease activity, Analysis: Kaplan-Meier curves, log-rank tests and Cox proportional hazards models
- Multicentre
- Prospective
- Open-label
- 1:1 randomisation
- Secondary outcomes: arterial thrombotic events, major bleeding, all-cause mortality, longitudinal changes in disease activity
- Analysis: Kaplan-Meier curves, log-rank tests and Cox proportional hazards models
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Comparison of aspirin and rivaroxaban for the prevention of pulmonary embolism and deep vein thrombosis in high thrombotic risk patients with systemic lupus erythematosus: study protocol for a multicentre, prospective, randomised controlled trial. Lupus Sci Med. Published 20 May 2026. doi:10.
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