Rivaroxaban Anticoagulation for Superficial Vein Thrombosis

Inclusion Criteria:

• Symptomatic Superficial Vein Thrombosis of the leg of ≥5 cm length (diagnosed clinicallyor with ultrasound)

Exclusion Criteria:

• Age <18 years

• Symptoms >42 days

• Receiving an anticoagulant for another indication (example: atrial fibrillation) whenSuperficial Vein Thrombosis started.

• Superficial Vein Thrombosis already treated with more than 3 days of anticoagulation (example. fondaparinux or Low Molecular Weight Heparin).

• Planned treatment of Superficial Vein Thrombosis with a course of anticoagulanttherapy.

• Another indication for anticoagulant therapy (example. Deep Vein Thrombosis, PulmonaryEmbolism, atrial fibrillation).

• Judged to require immediate ligation of the saphenofemoral junction or stripping ofthrombosed varicose veins.

• proximal Deep Vein Thrombosis or Pulmonary Embolism within the past 12 months.

• Superficial Vein Thrombosis associated with sclerotherapy or an intravenous canula.

• A high risk of bleeding as evidenced by any of the following:

1. Active bleeding

2. Bleeding within the past 30 days due to a cause that has not fully resolved.

3. Known or expected thrombocytopenia with a platelet count of less than 80,000 x 10 9/L.

4. History of ever having had spontaneous intracranial bleeding, or any intracranialbleeding within the past 3 months.

5. Receiving dual antiplatelet therapy (example. aspirin and clopidogrel).

• Elevated creatinine level is suspected and creatinine clearance has not beenestimated, OR creatinine clearance (Cockcroft-Gault equation) of less than 30 ml/min.

• Clinically relevant hepatic disease (including Child-Pugh B and C) is known orsuspected (example., associated with: International Normalized Ratio >1.7; totalbilirubin >2 upper limit of normal; or Alanine aminotransferase (ALT) or Aspartateaminotransferase (AST) >3 times upper limit of normal).

• Ongoing requirement for systemic treatment with azole-antimycotics (exceptfluconazole), Human Immunodeficiency Virus (HIV) -protease inhibitors, or strongCytochrome P450 3A4 (CYP3A4) inducers due to the potential interaction withrivaroxaban.

• Pregnant or lactating women, or at risk of becoming pregnant.

• Life expectancy less than 90 days

• Patient is unwilling or unable to comply with the protocol (example. unable to attendfollow-up visits because of geographic inaccessibility).

• Participating in a competing clinical investigation and receiving any otherinvestigational agent(s).