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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
85
University of Alberta Hospital
Edmonton, Alberta, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada
St Josephs Healthcare
Hamilton, Ontario, Canada
Juravinski Hospital
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).
Time frame: 90 days
Safety
Major bleeding within 90 days.
Time frame: 90 Days
Efficacy
The patient will self assess any change in leg pain using a Likert Scale.
Time frame: 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
Time frame: Baseline and day 45
Efficacy
Any use of oral analgesics and oral/topical anti-inflammatory agents.
Time frame: Baseline, day 7, day 45 and day 90
Safety
Death
Time frame: 90 days
Safety
major and minor bleeding
Time frame: 45 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hamilton, Ontario, Canada
McMaster Hospital
Hamilton, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Hopital Maisonneuve - Rosemount
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Hopital Sacre Coeur
Montreal, Quebec, Canada
Montreal General Hospital
Montreal, Quebec, Canada
...and 1 more locations