Symptomatic Superficial Vein Thrombosis
Conditions
Keywords
Superficial Vein Thrombosis
Brief summary
This is a Phase III, randomized, placebo controlled, blinded, parallel two arm, multicentre trial that will compare rivaroxaban 10mg daily with placebo in patients with symptomatic leg Superficial Vein Thrombosis (\> or = 5cm) that otherwise would not initially be treated with anticoagulant therapy.
Detailed description
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.
Interventions
DRUGRivaroxaban
DRUGPlacebo
Sponsors
Bayer
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | 90 days | Treatment failure at 90 days (composite of: treated with non-study anticoagulant therapy; proximal Deep Vein Thrombosis or Pulmonary Embolism; surgery for Superficial Vein Thrombosis). |
| Safety | 90 Days | Major bleeding within 90 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | Baseline,Day 7, Day 45 and Day 90 | The patient will self assess any change in leg pain using a Likert Scale. |
| Safety | 90 days | Death |
Countries
Canada
Outcome results
None listed