600 mg q.d. for 12 month

above knee stocking for 12 month

Venous Clinical Severity Score (VCSS) is a combination of subjective symptoms and objective signs of CVD aimed to assess the severity of disease and ranges from 0 (no signs and symptoms of CVD) to 30 (severe signs and symptoms of CVD)

Chronic Lower Limb Venous Insufficiency Questionnaire - 20 items (CIVIQ-20) is a venous specific questionnaire to assess the disease-specific quality of life (QoL). It contains 20 items of 1-5 scores, totally, from 20 (best QoL) to100 (worst QoL) scores.

Full recanalization of popliteal vein suggests the residual venous obstruction (RVO) less than 20%. The RVO was assessed by duplex ultrasound and calculated as the vein cross-sectional diameter under the maximal compression divided on the diameter without any compression multiplied by 100%.

Residual venous obstruction (RVO) defined as a thrombotic masses occupying 20% and more of the vein cross-sectional diameter was measured by duplex ultrasound and calculated as the vein cross-sectional diameter under the maximal compression divided on the diameter without compression and multiplied by 100%. The extension of RVO was assessed by Marder score, the sum of all affected venous segments, evaluated by different scores (see Appendix of the Protocol), that ranged from 0 (no RVO) to 34 (RVO in all possible venous segments in one limb).

any adverse events detected or suspected

according to the International Society of Thrombosis and Hemostasis (ISTH) definition, major bleeding defined as fatal bleeding, and/or symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing a fall in hemoglobin level of 20 g/L or 1.24 mmol/L or more, or leading to transfusion of two or more units of whole blood or red cells

any non-major bleeding requiring anticoagulant withdrawal, and/or performing haemostatic measures, and/or hospitalization, and/or an unscheduled medical appointment

any non-major or non-clinically relevant bleeding does not require the suspension of therapy and changes in the patient's lifestyle

Total of all reporting groups

Race and Ethnicity were not collected from any participant.

Number of days from DVT verification to randomization

DVT without any identified clinical provocation (e.g. major surgery, trauma, immobilization, pregnancy and postpartum, estrogen-containing pills, long-travel, etc)

Chronic venous disease (CVD) according to the Clinical-Etiology-Anatomy-Pathophysiology (CEAP) clinical class: C0 - no signs for CVD; C1 - telangiectasia and reticular veins; C2 - varicose veins; C3 - venous edema; C4 - skin pigmentation, induration, venous eczema of skin white atrophy; C5 - healed venous ulcer; C6 - active venous ulcer. Preexisting CVD suggests C2 and higher CEAP clinical class.

Extension of DVT assessed with duplex ultrasound by Marder score (see Appendix 1 to the Protocol): ranges from 0 (no thrombus) to 34 (occlusion of all veins in one limb).

detection of any episode of recurrent DVT with or without clinical signs verified by duplex ultrasound

detection of symptomatic pulmonary embolism verified with CT pulmonary angiogram

Venous Clinical Severity Score (VCSS) is a combination of subjective symptoms and objective signs of CVD aimed to assess the severity of disease and ranges from 0 (no signs and symptoms of CVD) to 30 (severe signs and symptoms of CVD)

Chronic Lower Limb Venous Insufficiency Questionnaire - 20 items (CIVIQ-20) is a venous specific questionnaire to assess the disease-specific quality of life (QoL). It contains 20 items of 1-5 scores, totally, from 20 (best QoL) to100 (worst QoL) scores.

Full recanalization of popliteal vein suggests the residual venous obstruction (RVO) less than 20%. The RVO was assessed by duplex ultrasound and calculated as the vein cross-sectional diameter under the maximal compression divided on the diameter without any compression multiplied by 100%.

Residual venous obstruction (RVO) defined as a thrombotic masses occupying 20% and more of the vein cross-sectional diameter was measured by duplex ultrasound and calculated as the vein cross-sectional diameter under the maximal compression divided on the diameter without compression and multiplied by 100%. The extension of RVO was assessed by Marder score, the sum of all affected venous segments, evaluated by different scores (see Appendix of the Protocol), that ranged from 0 (no RVO) to 34 (RVO in all possible venous segments in one limb).

any adverse events detected or suspected

according to the International Society of Thrombosis and Hemostasis (ISTH) definition, major bleeding defined as fatal bleeding, and/or symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing a fall in hemoglobin level of 20 g/L or 1.24 mmol/L or more, or leading to transfusion of two or more units of whole blood or red cells

any non-major bleeding requiring anticoagulant withdrawal, and/or performing haemostatic measures, and/or hospitalization, and/or an unscheduled medical appointment

any non-major or non-clinically relevant bleeding does not require the suspension of therapy and changes in the patient's lifestyle

standard treatment of DVT with anticoagulation (rivaroxaban) and elastic compression stockings

Rivaroxaban: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month

compression stockings: above knee stocking for 12 month