Superficial Vein Thrombosis (SVT) Treated With Rivaroxaban Versus Fondaparinux

Sponsor

GWT-TUD GmbH (Other)

Overall Status

Completed

CT.gov ID

NCT01499953

Collaborator

Bayer (Industry)

472

Enrollment

Locations

Arms

Duration (Months)

20.5

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Superficial Vein Thrombosis	Drug: Rivaroxaban Drug: Fondaparinux	Phase 3

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

Actual Enrollment :

472 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Superficial Vein Thrombosis (SVT) Treated for Forty-five Days With Rivaroxaban Versus Fondaparinux

Study Start Date :

Apr 1, 2012

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rivaroxaban Rivaroxaban for 45 days oral dose: 10 mg OD	Drug: Rivaroxaban Dose: 10 mg Duration: 45 (±5) days Frequency: once daily Application: oral Other Names: Xarelto
Active Comparator: Fondaparinux Fondaparinux for 45 days subcutaneous application: 2,5 mg OD	Drug: Fondaparinux Fondaparinux Dose: 2.5 mg Duration: 45 (±5) days Frequency: once daily Application: subcutaneous Other Names: Arixtra

Arm

Intervention/Treatment

Experimental: Rivaroxaban

Rivaroxaban for 45 days oral dose: 10 mg OD

Drug: Rivaroxaban

Dose: 10 mg Duration: 45 (±5) days Frequency: once daily Application: oral

Other Names:

Xarelto

Active Comparator: Fondaparinux

Fondaparinux for 45 days subcutaneous application: 2,5 mg OD

Drug: Fondaparinux

Fondaparinux Dose: 2.5 mg Duration: 45 (±5) days Frequency: once daily Application: subcutaneous

Other Names:

Arixtra

Outcome Measures

Primary Outcome Measures

Composit-Endpoint VTE [45 +/- 5 days]
Composite of death from any cause symptomatic pulmonary embolism symptomatic deep vein thrombosis symptomatic extension towards the saphenofemoral junction symptomatic recurrence of superficial vein thrombosis

Secondary Outcome Measures

composite primary efficacy outcome [90 +/- 10 days]
each component of primary efficacy outcome up to day 45 and day 90 [90 +/-10 days]
symptomatic pulmonary embolism symptomatic deep vein thrombosis symptomatic extension towards the saphenofemoral junction symptomatic recurrence of superficial vein thrombosis death from any cause
rate of major VTE [90 +/-10 days]
composite of: symptomatic pulmonary embolism symptomatic proximal DVT VTE-related death
rates of surgery for SVT [90 +/-10 days]

Other Outcome Measures

Major bleeding (Main safety outcome) [45 +/- 5 days]
associated with a fall of hemoglobin of 2 g/l or more, or; leading to a transfusion of 2 or more units of packed red blood cells or whole blood, or; occurring into a critical site such as intracranial, intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or; fatal bleeding.
clinically relevant non-major, minor and total (any) bleeding [45 +/- 5 days]
Clinically relevant, non-major bleeding is defined as any overt bleeding and associated with a medical intervention, or unscheduled contact with the physician (presence or telephone contact) temporary or complete cessation of study drug associated with any relevant discomfort to the patient (pain, impairment of activities of daily life)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hautarztpraxis	Freiburg	Baden-Württemberg	Germany	79098
2	Gemeinschaftspraxis Mietaschk, Bilderling, Kaiser, Tato	München	Bayern	Germany	80331
3	Chriurgische Praxisklinik	Baesweiler	Nordrhein-Westfalen	Germany	52499
4	Krankenhaus Dresden-Friedrichstadt	Dresden	Sachsen	Germany	01067
5	Universitätsklinikum Dresden	Dresden	Sachsen	Germany	01307
6	Oberlausitz-Gefäßpraxis	Görlitz	Sachsen	Germany	02826
7	Franziskus-Krankenhaus Berlin	Berlin		Germany	10787
8	MVZ Ramdohr, Praxis für Cardiovaskulär- u. Ultraschalldiagnostik	Berlin		Germany	12043
9	Praxis für Chirurgie & Gefäßmedizin	Berlin		Germany	12627
10	Klinikum Darmstadt GmbH	Darmstadt		Germany	64283
11	Gemeinschaftspraxis Eggeling und Winter	Eschwege		Germany	37269
12	Asklepios Westklinikum Hamburg	Hamburg		Germany	22559
13	Universitätsklinikum Heidelberg	Heidelberg		Germany	69120
14	Internistische Praxisgemeinschaft	Hoppegarten		Germany	15366
15	Akademie für Gefäßkrankheiten e.V.	Karlsbach		Germany	76307
16	Praxis für Allgemeinmedizin und Phlebologie	Köln		Germany	50670
17	Universitätsklinikum Leipzig AöR Innere Medizin - Angiologische Ambulanz	Leipzig		Germany
18	Universitätsklinikum Schleswig-Holstein, Campus Lübeck	Lübeck		Germany	23538
19	Praxis Dr. Franke	Magdeburg		Germany	39112
20	Kardiologie Mühldorf am Inn	Mühldorf am Inn		Germany	84453
21	Praxis Dr. Kähler	Rostock		Germany	18059
22	Praxis für Gefäßmedizin am Tegernsee	Rottach-Egern		Germany	83700
23	Venenzentrum Wiesbaden	Wiesbaden		Germany	65183