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Rivaroxaban Anticoagulation for Superficial Vein Thrombosis (RASET)

Primary Purpose

Symptomatic Superficial Vein Thrombosis

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Rivaroxaban
Placebo
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Symptomatic Superficial Vein Thrombosis focused on measuring Superficial Vein Thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of Alberta Hospital
  • Hamilton General Hospital
  • St Josephs Healthcare
  • Juravinski Hospital
  • McMaster Hospital
  • The Ottawa Hospital
  • Hopital Maisonneuve - Rosemount
  • Jewish General Hospital
  • Hopital Sacre Coeur
  • Montreal General Hospital
  • St Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rivaroxaban

Control

Arm Description

Rivaroxaban 10mg tablet daily for 45 days

Placebo tablet daily for 45 days

Outcomes

Primary Outcome Measures

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).
Safety
Major bleeding within 90 days.

Secondary Outcome Measures

Efficacy
The patient will self assess any change in leg pain using a Likert Scale.
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
Efficacy
Any use of oral analgesics and oral/topical anti-inflammatory agents.
Safety
Death
Safety
major and minor bleeding

Full Information

First Posted
April 23, 2014
Last Updated
December 3, 2018
Sponsor
McMaster University
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT02123524
Brief Title
Rivaroxaban Anticoagulation for Superficial Vein Thrombosis
Acronym
RASET
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

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
November 11, 2014 (Actual)
Primary Completion Date
December 3, 2018 (Actual)
Study Completion Date
December 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
Bayer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Superficial Vein Thrombosis
Keywords
Superficial Vein Thrombosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rivaroxaban
Arm Type
Experimental
Arm Description
Rivaroxaban 10mg tablet daily for 45 days
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo tablet daily for 45 days
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Efficacy
Description
"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
Title
Safety
Description
Major bleeding within 90 days.
Time Frame
90 Days
Secondary Outcome Measure Information:
Title
Efficacy
Description
The patient will self assess any change in leg pain using a Likert Scale.
Time Frame
Baseline,Day 7, Day 45 and Day 90
Title
Efficacy
Description
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
Title
Efficacy
Description
Any use of oral analgesics and oral/topical anti-inflammatory agents.
Time Frame
Baseline, day 7, day 45 and day 90
Title
Safety
Description
Death
Time Frame
90 days
Title
Safety
Description
major and minor bleeding
Time Frame
45 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clive Kearon, MD
Organizational Affiliation
McMaster University/ Hamilton Health Sciences, Juravinski Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L2X2
Country
Canada
Facility Name
St Josephs Healthcare
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N4A6
Country
Canada
Facility Name
Juravinski Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V1C3
Country
Canada
Facility Name
McMaster Hospital
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H8L6
Country
Canada
Facility Name
Hopital Maisonneuve - Rosemount
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T1E2
Country
Canada
Facility Name
Hopital Sacre Coeur
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J1C5
Country
Canada
Facility Name
Montreal General Hospital
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
St Mary's Hospital
City
Montreal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.ocog.ca
Description
Related Info

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Rivaroxaban Anticoagulation for Superficial Vein Thrombosis

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