Symptomatic Superficial Vein Thrombosis Clinical Trial
— RASETOfficial title:
A Phase III, Multi-centre, Randomized Trial to Compare Rivaroxaban With Placebo for the Treatment of Symptomatic Leg Superficial Vein Thrombosis
| Verified date | December 2018 |
| Source | McMaster University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 85 |
| Est. completion date | December 3, 2018 |
| Est. primary completion date | December 3, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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). |
| Country | Name | City | State |
|---|---|---|---|
| Canada | University of Alberta Hospital | Edmonton | Alberta |
| Canada | Hamilton General Hospital | Hamilton | Ontario |
| Canada | Juravinski Hospital | Hamilton | Ontario |
| Canada | McMaster Hospital | Hamilton | Ontario |
| Canada | St Josephs Healthcare | Hamilton | Ontario |
| Canada | Hopital Maisonneuve - Rosemount | Montreal | Quebec |
| Canada | Hopital Sacre Coeur | Montreal | Quebec |
| Canada | Jewish General Hospital | Montreal | Quebec |
| Canada | Montreal General Hospital | Montreal | Quebec |
| Canada | St Mary's Hospital | Montreal | Quebec |
| Canada | The Ottawa Hospital | Ottawa | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| McMaster University | Bayer |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | Safety | Major bleeding within 90 days. | 90 Days | |
| Secondary | Efficacy | The patient will self assess any change in leg pain using a Likert Scale. | Baseline,Day 7, Day 45 and Day 90 | |
| Secondary | 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 | Baseline and day 45 | |
| Secondary | Efficacy | Any use of oral analgesics and oral/topical anti-inflammatory agents. | Baseline, day 7, day 45 and day 90 | |
| Secondary | Safety | Death | 90 days | |
| Secondary | Safety | major and minor bleeding | 45 days |