Aspirin® Plus Rivaroxaban Versus Rivaroxaban Alone for the Prevention of Venous Stent Thrombosis in Patients With PTS

Phase 2 Terminated 172 enrolled University of Zurich Klinikum Arnsberg · collab Medical University of Vienna · collab RWTH Aachen University · collab University Hospital Freiburg · collab University Hospital Heidelberg · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

To show if a combination therapy of rivaroxaban plus Aspirin® is more efficient (superiority testing) as rivaroxaban alone in the prevention of early venous stent thrombosis in patients suffering from post-thrombotic syndrome in the first 6 months following endovascular therapy To demonstrate tolerability of combination therapy of Aspirin® plus rivaroxaban in long-term treatment.

Timeline

Start: 2020-03-11
Primary completion: 2024-02-21
Completion: 2024-02-21

Outcome

Missed primary endpoint

Stopped: “Recommendation by DSMB”

paper The primary patency rate at 6 months was 94.8% versus 92.4% (absolute risk difference, 2.4% [95% CI, -13.6 to 18.0]), respectively. PMID 39874026 ↗

Publications

Barco S, Jalaie H, Sebastian T, Wolf S, Fumagalli RM, Lichtenberg M, Zeller T, Erbel C, Schlager O, Kucher N. Aspirin Plus Rivaroxaban Versus Rivaroxaban Alone for the Prevention of Venous Stent Thrombosis Among Patients With Post-Thrombotic Syndrome: The Multicenter, Multinational, Randomized, Open-Label ARIVA Trial. Circulation. 2025 Mar 25;151(12):835-846. doi: 10.1161/CIRCULATIONAHA.124.073050. Epub 2025 Jan 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aspirin	Small molecule	100 mg	Oral