Clinical trial NCT02123524: Rivaroxaban Anticoagulation for Superficial Vein Thrombosis
Official title: A Phase III, Multi-centre, Randomized Trial to Compare Rivaroxaban With Placebo for the Treatment of Symptomatic Leg Superficial Vein Thrombosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Symptomatic Superficial Vein Thrombosis
Keywords: Superficial Vein Thrombosis
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2014-04-25
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Efficacy
timeFrame: 90 days
measure: Safety
timeFrame: 90 Days
Secondary outcomes:
measure: Efficacy
timeFrame: Baseline,Day 7, Day 45 and Day 90
measure: Efficacy
timeFrame: Baseline and day 45
measure: Efficacy
timeFrame: Baseline, day 7, day 45 and day 90
measure: Safety
timeFrame: 90 days
measure: Safety
timeFrame: 45 days
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: St Josephs Healthcare
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Hospital
state: Ontario
city: Hamilton
country: Canada
facility: McMaster Hospital
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Montreal
country: Canada
facility: Hopital Maisonneuve - Rosemount
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montreal
country: Canada
facility: Hopital Sacre Coeur
state: Quebec
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
city: Montreal
country: Canada
facility: St Mary's Hospital
state: Quebec
Study officials:
affiliation: McMaster University/ Hamilton Health Sciences, Juravinski Hospital
name: Clive Kearon, MD
role: PRINCIPAL_INVESTIGATOR
References: