Rivaroxaban Anticoagulation for Superficial Vein Thrombosis
- Conditions
- Symptomatic Superficial Vein Thrombosis
- Interventions
- Drug: Placebo
- Registration Number
- NCT02123524
- Lead Sponsor
- McMaster University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 85
- Symptomatic Superficial Vein Thrombosis of the leg of ≥5 cm length (diagnosed clinically or with ultrasound)
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Age <18 years
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Symptoms >42 days
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Receiving an anticoagulant for another indication (example: atrial fibrillation) when Superficial Vein Thrombosis started.
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Superficial Vein Thrombosis already treated with more than 3 days of anticoagulation (example. fondaparinux or Low Molecular Weight Heparin).
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Planned treatment of Superficial Vein Thrombosis with a course of anticoagulant therapy.
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Another indication for anticoagulant therapy (example. Deep Vein Thrombosis, Pulmonary Embolism, atrial fibrillation).
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Judged to require immediate ligation of the saphenofemoral junction or stripping of thrombosed varicose veins.
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proximal Deep Vein Thrombosis or Pulmonary Embolism within the past 12 months.
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Superficial Vein Thrombosis associated with sclerotherapy or an intravenous canula.
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A high risk of bleeding as evidenced by any of the following:
- Active bleeding
- Bleeding within the past 30 days due to a cause that has not fully resolved.
- Known or expected thrombocytopenia with a platelet count of less than 80,000 x 10 9/L.
- History of ever having had spontaneous intracranial bleeding, or any intracranial bleeding within the past 3 months.
- Receiving dual antiplatelet therapy (example. aspirin and clopidogrel).
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Elevated creatinine level is suspected and creatinine clearance has not been estimated, OR creatinine clearance (Cockcroft-Gault equation) of less than 30 ml/min.
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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).
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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.
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Pregnant or lactating women, or at risk of becoming pregnant.
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Life expectancy less than 90 days
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Patient is unwilling or unable to comply with the protocol (example. unable to attend follow-up visits because of geographic inaccessibility).
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Participating in a competing clinical investigation and receiving any other investigational agent(s).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rivaroxaban Rivaroxaban Rivaroxaban 10mg tablet daily for 45 days Control Placebo Placebo tablet daily for 45 days
- Primary Outcome Measures
Name Time Method Safety 90 Days Major bleeding within 90 days.
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).
- Secondary Outcome Measures
Name Time Method Efficacy Baseline, day 7, day 45 and day 90 Any use of oral analgesics and oral/topical anti-inflammatory agents.
Safety 45 days major and minor bleeding
Trial Locations
- Locations (11)
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Montreal General Hospital
🇨🇦Montreal, Quebec, Canada
McMaster Hospital
🇨🇦Hamilton, Ontario, Canada
The Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
Hopital Sacre Coeur
🇨🇦Montreal, Quebec, Canada
St Mary's Hospital
🇨🇦Montreal, Quebec, Canada
Hamilton General Hospital
🇨🇦Hamilton, Ontario, Canada
St Josephs Healthcare
🇨🇦Hamilton, Ontario, Canada
Hopital Maisonneuve - Rosemount
🇨🇦Montreal, Quebec, Canada
Juravinski Hospital
🇨🇦Hamilton, Ontario, Canada
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada