Rivaroxaban Anticoagulation for Superficial Vein Thrombosis (RASET)

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

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.

Study Overview

• Status: Completed
• Conditions: Symptomatic Superficial Vein Thrombosis
• Intervention / Treatment: Drug: Placebo; Drug: Rivaroxaban

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.

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta Hospital
  • Ontario
    • Hamilton, Ontario, Canada, L8L2X2
      • Hamilton General Hospital
    • Hamilton, Ontario, Canada, L8N4A6
      • St Josephs Healthcare
    • Hamilton, Ontario, Canada, L8V1C3
      • Juravinski Hospital
    • Hamilton, Ontario, Canada
      • McMaster Hospital
    • Ottawa, Ontario, Canada, K1H8L6
      • The Ottawa Hospital
  • Quebec
    • Montreal, Quebec, Canada, H3T1E2
      • Jewish General Hospital
    • Montreal, Quebec, Canada, H1T 2M4
      • Hopital Maisonneuve - Rosemount
    • Montreal, Quebec, Canada, H4J1C5
      • Hopital Sacre Coeur
    • Montreal, Quebec, Canada
      • Montreal General Hospital
    • Montreal, Quebec, Canada
      • St Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rivaroxaban; Rivaroxaban 10mg tablet daily for 45 days	Drug: Rivaroxaban
Placebo Comparator: Control; Placebo tablet daily for 45 days	Drug: Placebo

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: Bayer
• Investigators: Principal Investigator: Clive Kearon, MD, McMaster University/ Hamilton Health Sciences, Juravinski Hospital

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2014
• Primary Completion (Actual): December 3, 2018
• Study Completion (Actual): December 3, 2018

Study Registration Dates

• First Submitted: April 23, 2014
• First Submitted That Met QC Criteria: April 23, 2014
• First Posted (Estimate): April 25, 2014

Study Record Updates

• Last Update Posted (Actual): December 4, 2018
• Last Update Submitted That Met QC Criteria: December 3, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Superficial Vein Thrombosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban
• Other Study ID Numbers: OCOG-2013-RASET