NCT02123524

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2014

Typical duration for phase_3

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

November 11, 2014

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2018

Completed
Last Updated

December 4, 2018

Status Verified

December 1, 2018

Enrollment Period

4.1 years

First QC Date

April 23, 2014

Last Update Submit

December 3, 2018

Conditions

Symptomatic Superficial Vein Thrombosis

Keywords

Superficial Vein Thrombosis

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Efficacy

    Baseline,Day 7, Day 45 and Day 90

  • Efficacy

    Baseline and day 45

  • Efficacy

    Baseline, day 7, day 45 and day 90

  • Safety

    90 days

  • Safety

    45 days

Study Arms (2)

Rivaroxaban

EXPERIMENTAL

Rivaroxaban 10mg tablet daily for 45 days

Drug: Rivaroxaban

Control

PLACEBO COMPARATOR

Placebo tablet daily for 45 days

Drug: Placebo

Interventions

RivaroxabanDRUG
Rivaroxaban
PlaceboDRUG
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Symptomatic Superficial Vein Thrombosis of the leg of ≥5 cm length (diagnosed clinically or with ultrasound)

You may not qualify if:

  • 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).
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Hamilton General Hospital

Hamilton, Ontario, L8L2X2, Canada

Location

St Josephs Healthcare

Hamilton, Ontario, L8N4A6, Canada

Location

Juravinski Hospital

Hamilton, Ontario, L8V1C3, Canada

Location

McMaster Hospital

Hamilton, Ontario, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H8L6, Canada

Location

Hopital Maisonneuve - Rosemount

Montreal, Quebec, H1T 2M4, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T1E2, Canada

Location

Hopital Sacre Coeur

Montreal, Quebec, H4J1C5, Canada

Location

Montreal General Hospital

Montreal, Quebec, Canada

Location

St Mary's Hospital

Montreal, Quebec, Canada

Location

Related Links

MeSH Terms

Interventions

Rivaroxaban

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Clive Kearon, MD

    McMaster University/ Hamilton Health Sciences, Juravinski Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2014

First Posted

April 25, 2014

Study Start

November 11, 2014

Primary Completion

December 3, 2018

Study Completion

December 3, 2018

Last Updated

December 4, 2018

Record last verified: 2018-12

Locations

CA(11)