Rivaroxaban Anticoagulation for Superficial Vein Thrombosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase III, Multi-centre, Randomized Trial to Compare Rivaroxaban With Placebo for the Treatment of Symptomatic Leg Superficial Vein Thrombosis

Conditions
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Symptomatic Superficial Vein Thrombosis

Intervention / Treatment
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* Drug: Rivaroxaban
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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: 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). 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rivaroxaban<br>Rivaroxaban 10mg tablet daily for 45 days | Drug: Rivaroxaban<br> <br> |
| Placebo Comparator: Control<br>Placebo tablet daily for 45 days | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | 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). | 90 days | 
| Safety | Major bleeding within 90 days. | 90 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | The patient will self assess any change in leg pain using a Likert Scale. | Baseline,Day 7, Day 45 and Day 90 | 
| Efficacy | Patients will rate any change in venous disease-specific quality of life (QOL) (VEINES-QOL and VEINES-Symptoms) and general health-related QOL (SF-36v2) at 45 days | Baseline and day 45 | 
| Efficacy | Any use of oral analgesics and oral/topical anti-inflammatory agents. | Baseline, day 7, day 45 and day 90 | 
| Safety | Death | 90 days | 
| Safety | major and minor bleeding | 45 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Superficial Vein Thrombosis