NCT01499953CompletedPhase 3
Superficial Vein Thrombosis (SVT) Treated for Forty-five Days With Rivaroxaban Versus Fondaparinux
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- GWT-TUD GmbH
- Enrollment
- 472
- Locations
- 23
- Primary Endpoint
- Rate of Objectively Confirmed VTE Complications
Study Overview
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of rivaroxaban versus fondaparinux in the treatment of superficial vein thrombosis (SVT).
Detailed Description
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •thrombus extension of at least 5 cm
- •proximal thrombus end with more than 3 cm distance to the saphenofemoral junction (SFJ)
- •age > 18 years
- •written informed consent
Exclusion Criteria
- •other indication for therapeutic anticoagulation such as acute deep vein thrombosis, acute pulmonary embolism, atrial fibrillation with indication for anticoagulant therapy
- •any PE or DVT within last 6 months before inclusion
- •clinical signs of PE without objective exclusion (CT or VQ scan, angiography)
- •SVT without signs of thrombotic/inflammatory activity (activity signs: diameter > 4 mm, pain, redness, elevated local or systemic temperature)
- •SVT after sclerotherapy
- •Duration of symptoms > 3 weeks
- •pretreatment of more than 72 h with therapeutic dosages of oral or parenteral anticoagulants
- •pretreatment of more than 5 days with subtherapeutic oral or parenteral anticoagulants
- •indication for escalated antiplatelet therapy (monotherapy with aspirin > 325 g/d and any dual antiplatelet therapy)
- •SVT closer than 3 cm to saphenofemoral junction (SVJ)
- •anticipated superficial vein surgery within 90 days
- •anticipated thrombolytic therapy within 90 days
- •manifest clinically relevant bleeding
- •clinically relevant bleeding in the last 30 days before study inclusion
- •major surgery within last 30 days before inclusion
- •ophthalmic, spinal or cerebral surgery within last 90 days
- •severe head trauma within last 90 days
- •hemorrhagic stroke within last 12 months
- •hereditary or acquired severe hemorrhagic diathesis
- •gastrointestinal bleeding within last 90 days requiring endoscopy
- •uncontrolled arterial hypertension (systolic > 180 mm Hg, diastolic > 110 mm Hg)
- •acute endocarditis
- •low platelet count (< 100 x 109/l)
- •Prothrombin time < 50 %
- •calculated creatinine clearance < 30 ml/min
- •significant liver disease such as acute hepatitis, chronic active hepatitis, cirrhosis
- •life expectancy < 3 months
- •any contraindications listed for rivaroxaban or fondaparinux
- •women of child bearing potential without safe contraception method
- •pregnant or breastfeeding women
- •participation in another trial with pharmacological intervention
Arms & Interventions
Rivaroxaban
Experimental
Rivaroxaban for 45 days oral dose: 10 mg OD
Intervention: Rivaroxaban (Drug)
Fondaparinux
Active Comparator
Fondaparinux for 45 days subcutaneous application: 2,5 mg OD
Intervention: Fondaparinux (Drug)
Outcomes
Primary Outcomes
Rate of Objectively Confirmed VTE Complications
Time Frame: 45 +/- 5 days
The primary efficacy outcome was the composite of death from any cause, symptomatic pulmonary embolism (confirmed by ventilation-perfusion scanning, helical computed tomography, pulmonary angiography, or autopsy), symptomatic deep vein thrombosis (confirmed by ultrasonography or venography), or symptomatic extension towards the saphenofemoral junction or symptomatic recurrence of superficial vein thrombosis (confirmed by ultrasonography) up to day 45.
Secondary Outcomes
- Rate of Major VTE(90 +/-10 days)
- Rates of Surgery for SVT(90 +/-10 days)
- Composite Primary Efficacy Outcome(90 +/- 10 days)
Investigators
Study Sites (23)
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