Superficial vein thrombosis (SVT) of legs treated with Rivaroxaban versus Fondaparinux
Phase 1
- Conditions
- ower extremity superficial vein thrombosis (SVT)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2011-005158-73-DE
- Lead Sponsor
- GWT-TUD GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
?acute symptomatic supragenual superficial vein thrombosis of the leg
?at least one of the following major risk factor for VTE:
-age > 65 years or
-male sex or
-history of DVT/PE/SVT or
-history of cancer or active cancer or
-autoimmune disease or
-SVT of a non-varicose vein
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 506
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 506
Exclusion Criteria
?renal insufficiency (< 30 ml/min)
?high risk of bleeding
?indication for therapeutic anticoagulation
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluation of efficacy and safety of 45 days of rivaroxaban 10 mg vs. fondaparinux 2.5 mg in the treatment of superficial vein thrombosis of risk patients for major VTE complications to prove non-inferiority of oral rivaroxaban treatment;Secondary Objective: all cause mortality rate at 90 days<br>rate of bleeding (major and non-major clinically relevant) at 90 days <br>;Primary end point(s): ?rate of objectively confirmed VTE complications (composite of death from any cause, objectively confirmed symptomatic pulmonary embolism or deep vein thrombosis, symptomatic extension of SVT towards the saphenofemoral junction or symptomatic recurrence of SVT at 47 days;Timepoint(s) of evaluation of this end point: 45 day (+/- 5 days)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): ?all cause mortality rate at 90 days<br>?rate of bleeding (major and non-major clinically relevant) at 90 days <br>;Timepoint(s) of evaluation of this end point: 90 days (+/- 10 days)