UMIN000028105.

Trial name or title	Evaluation of rivaroxaban for distal deep vein thrombosis – a single center, randomized, open‐label, assessor‐blind, parallel group, exploratory study
Methods	Randomised, open‐label, with blinded assessors
Participants	150 men and women aged ≥ 20 years, who have been newly diagnosed with distal DVT by CUS
Interventions	Rivaroxaban vs physical treatment only Rivaroxaban: 15 mg tablets orally administered after meal twice daily for 21 days after starting treatment (initial treatment period). Subsequently, dosage reduced to 15 mg tablet once daily for 69 days (maintenance period). If there is a bleeding risk in the initial treatment period, dosage can be reduced to 15 mg tablet once daily according to judgement of physician. In addition, physical therapy including wearing an elastic stocking or an elastic wrap shall be thoroughly instructed. Physical treatment: physical therapy including wearing an elastic stocking or an elastic wrap.
Outcomes	Primary outcome Composite endpoint of asymptomatic proximal DVT, symptomatic proximal DVT, symptomatic non‐fatal PE or fatal PE, within 90 days after starting the study Secondary outcomes 1. Occurrences of recurrent distal DVT within 90 days after starting study 2. Occurrences of symptomatic proximal DVT within 90 days after starting study 3. Occurrences of asymptomatic proximal DVT within 90 days after starting study 4. Occurrences of symptomatic PE (fatal or non‐fatal) within 90 days after starting study 5. Composite of 1–4 6. Occurrences of recurrent distal DVT within 120, 180 and 365 days after starting study 7. Occurrences of symptomatic proximal DVT within 120, 180 and 365 days after starting study 8. Occurrences of asymptomatic proximal DVT within 120, 180 and 365 days after starting study 9. Occurrences of symptomatic PE (fatal or non‐fatal) within 120, 180 and 365 days after starting study 10. Composite of 6–9 11. Composite of 7–9 12. Change in thrombus volume in 8, 21 and 90 days after starting study 13. Biomarkers related to fibrinolytic and coagulation system (D‐dimer, soluble fibrin) 14. Occurrences of *clinically relevant bleeding events within 90, 120, 180 and 365 days after starting study (*clinically relevant bleeding events: composite endpoint of major bleeding events or other clinically relevant non‐major bleeding events) 15. Composite of asymptomatic proximal DVT, symptomatic proximal DVT, symptomatic PE (fatal or non‐fatal), or clinically relevant bleeding events within 90, 120, 180 and 365 days after starting study 16. Composite of asymptomatic proximal DVT, symptomatic proximal DVT, symptomatic PE (fatal or non‐fatal), or major bleeding events within 90, 120, 180 and 365 days after starting study
Starting date	2 April 2018
Contact information	Masaaki Ito, Mie University Graduate School of Medicine, Japan
Notes

CUS: compression ultrasonography; DVT: deep vein thrombosis; LMWH: low molecular weight heparin; PE: pulmonary embolism; PTS: post‐thrombotic syndrome; sc: subcutaneous; VEINES‐QOL/Sym: VEnous INsufficiency Epidemiological and Economic Study – Quality Of Life/Symptoms; VTE: venous thromboembolism.