Rivaroxaban Anticoagulation for Superficial Vein Thrombosis

Launched by MCMASTER UNIVERSITY · Apr 23, 2014

Keywords

ClinConnect Summary

Patients with symptomatic superficial leg thrombosis will be randomized into two arms, a) rivaroxaban 10mg 1 tablet daily for 45 days or b) placebo to determine if rivaroxaban (10 mg once daily) is an effective and safe treatment for superficial vein thrombosis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • - Symptomatic Superficial Vein Thrombosis of the leg of ≥5 cm length (diagnosed clinically or with ultrasound)
• Exclusion Criteria:
• • Age \<18 years
• • Symptoms \>42 days
• • Receiving an anticoagulant for another indication (example: atrial fibrillation) when Superficial 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 anticoagulant therapy.
• • Another indication for anticoagulant therapy (example. Deep Vein Thrombosis, Pulmonary Embolism, atrial fibrillation).
• • Judged to require immediate ligation of the saphenofemoral junction or stripping of thrombosed 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 intracranial bleeding within the past 3 months.
• • 5. Receiving dual antiplatelet therapy (example. aspirin and clopidogrel).
• • Elevated creatinine level is suspected and creatinine clearance has not been estimated, OR creatinine clearance (Cockcroft-Gault equation) of less than 30 ml/min.
• • Clinically relevant hepatic disease (including Child-Pugh B and C) is known or suspected (example., associated with: International Normalized Ratio \>1.7; total bilirubin \>2 upper limit of normal; or Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) \>3 times upper limit of normal).
• • Ongoing requirement for systemic treatment with azole-antimycotics (except fluconazole), Human Immunodeficiency Virus (HIV) -protease inhibitors, or strong Cytochrome P450 3A4 (CYP3A4) inducers due to the potential interaction with rivaroxaban.
• • 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 attend follow-up visits because of geographic inaccessibility).
• • Participating in a competing clinical investigation and receiving any other investigational agent(s).