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Comparison of aspirin and rivaroxaban for the prevention of pulmonary embolism and deep vein thrombosis in high thrombotic risk patients with systemic lupus erythematosus (PREVENT-SLE)

Comparison of aspirin and rivaroxaban for the prevention of pulmonary embolism and deep vein thrombosis in high thrombotic risk patients with systemic lupus erythematosus (PREVENT-SLE)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117175
Enrollment
Unknown
Registered
2026-01-20
Start date
2026-01-21
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

Systemic lupus erythematosus

Interventions

Aspirin group:Take 100mg of aspirin per day
Rivaroxaban group:Take 10mg of rivaroxaban per day

Sponsors

The Second Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Classified as SLE according to the 2019 EULAR/ACR classification criteria; (2) Age >= 18 years old; (3) aPLs were negative in two consecutive tests (with an interval of >= 12 weeks): Lupus anticoagulant negative; Anti-cardiolipin antibody IgG/IgM 2.0 µg/mL (FEU) (2000 ug/L) and no obvious acute trigger; SLE-VTE score >= 100 points.

Exclusion criteria

Exclusion criteria: (1) Active bleeding or high-risk of bleeding (platelet count 5 times ULN); (3) Severe renal insufficiency (eGFR 12 points or requiring high-dose hormones / strong immunosuppression initiation / escalation; (10) Participating in other interventional clinical trials simultaneously; (11) Refusing to sign the informed consent form; (12) Healthcare workers participating in this study.

Design outcomes

Primary

MeasureTime frame
Pulmonary embolism;Venous thrombosis (Deep Vein Thrombosis);

Secondary

MeasureTime frame
Arterial thrombosis event;Massive hemorrhage event (according to ISTH standards);All-cause mortality;Change in disease activity;

Countries

China

Contacts

Public ContactQiming Liu

The Second Xiangya Hospital of Central South University

qimingliu@csu.edu.cn+86 138 7318 1753

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 22, 2026