Rivaroxaban Anticoagulation for Superficial Vein Thrombosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-11

Study Completion Date

2018-12-03

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Symptomatic Superficial Vein Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Rivaroxaban

Rivaroxaban 10mg tablet daily for 45 days

Group Type EXPERIMENTAL

Rivaroxaban

Intervention Type DRUG

Control

Placebo tablet daily for 45 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Rivaroxaban

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No