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Rivaroxaban Anticoagulation for Superficial Vein Thrombosis (RASET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02123524
Recruitment Status : Completed
First Posted : April 25, 2014
Last Update Posted : December 4, 2018
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
McMaster University

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.

Condition or disease Intervention/treatment Phase
Symptomatic Superficial Vein Thrombosis Drug: Rivaroxaban Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Multi-centre, Randomized Trial to Compare Rivaroxaban With Placebo for the Treatment of Symptomatic Leg Superficial Vein Thrombosis
Actual Study Start Date : November 11, 2014
Actual Primary Completion Date : December 3, 2018
Actual Study Completion Date : December 3, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

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



Primary Outcome Measures :
  1. Efficacy [ Time Frame: 90 days ]
    "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).

  2. Safety [ Time Frame: 90 Days ]
    Major bleeding within 90 days.


Secondary Outcome Measures :
  1. Efficacy [ Time Frame: Baseline,Day 7, Day 45 and Day 90 ]
    The patient will self assess any change in leg pain using a Likert Scale.

  2. Efficacy [ Time Frame: Baseline and day 45 ]
    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

  3. Efficacy [ Time Frame: Baseline, day 7, day 45 and day 90 ]
    Any use of oral analgesics and oral/topical anti-inflammatory agents.

  4. Safety [ Time Frame: 90 days ]
    Death

  5. Safety [ Time Frame: 45 days ]
    major and minor bleeding



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02123524


Locations
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Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L2X2
St Josephs Healthcare
Hamilton, Ontario, Canada, L8N4A6
Juravinski Hospital
Hamilton, Ontario, Canada, L8V1C3
McMaster Hospital
Hamilton, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H8L6
Canada, Quebec
Hopital Maisonneuve - Rosemount
Montreal, Quebec, Canada, H1T 2M4
Jewish General Hospital
Montreal, Quebec, Canada, H3T1E2
Hopital Sacre Coeur
Montreal, Quebec, Canada, H4J1C5
Montreal General Hospital
Montreal, Quebec, Canada
St Mary's Hospital
Montreal, Quebec, Canada
Sponsors and Collaborators
McMaster University
Bayer
Investigators
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Principal Investigator: Clive Kearon, MD McMaster University/ Hamilton Health Sciences, Juravinski Hospital

Additional Information:
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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT02123524     History of Changes
Other Study ID Numbers: OCOG-2013-RASET
First Posted: April 25, 2014    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018
Keywords provided by McMaster University:
Superficial Vein Thrombosis
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants