Rivaroxaban Anticoagulation for Superficial Vein Thrombosis (RASET)

McMaster University

Status and phase

Completed

Phase 3

Conditions

Symptomatic Superficial Vein Thrombosis

Treatments

Drug: Rivaroxaban

Drug: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02123524

OCOG-2013-RASET

Details and patient eligibility

About

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.

Full 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.

Enrollment

85 patients

Sex

All

Ages

18+ years old

Volunteers

No 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).