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Superficial Vein ThrombosisPhase 3NCT01499953

Superficial Vein Thrombosis (SVT) Treated With Rivaroxaban Versus Fondaparinux

A Phase 3 study testing Rivaroxaban and Fondaparinux in people with Superficial Vein Thrombosis, run by GWT-TUD GmbH at 23 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Superficial Vein Thrombosis
What is being tested?
Rivaroxaban and Fondaparinux
Could I receive a placebo?
No, everyone receives an active treatment
How many people
472 participants
Where
23 sitesGermany
Study dates
Apr 2012to May 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • 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
Show all 31Show fewer
  • 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

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

Germany23 sites

  • Chriurgische Praxisklinik

    Baesweiler, North Rhine-Westphalia, 52499

  • Franziskus-Krankenhaus Berlin

    Berlin, 10787

  • MVZ Ramdohr, Praxis für Cardiovaskulär- u. Ultraschalldiagnostik

    Berlin, 12043

  • Praxis für Chirurgie & Gefäßmedizin

    Berlin, 12627

  • Praxis für Allgemeinmedizin und Phlebologie

    Cologne, 50670

  • Klinikum Darmstadt GmbH

    Darmstadt, 64283

  • Krankenhaus Dresden-Friedrichstadt

    Dresden, Saxony, 01067

  • Universitätsklinikum Dresden

    Dresden, Saxony, 01307

  • Gemeinschaftspraxis Eggeling und Winter

    Eschwege, 37269

  • Hautarztpraxis

    Freiburg im Breisgau, Baden-Wurttemberg, 79098

  • Oberlausitz-Gefäßpraxis

    Görlitz, Saxony, 02826

  • Asklepios Westklinikum Hamburg

    Hamburg, 22559

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Internistische Praxisgemeinschaft

    Hoppegarten, 15366

  • Akademie für Gefäßkrankheiten e.V.

    Karlsbach, 76307

  • Universitätsklinikum Leipzig AöR Innere Medizin - Angiologische Ambulanz

    Leipzig

  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck

    Lübeck, 23538

  • Praxis Dr. Franke

    Magdeburg, 39112

  • Kardiologie Mühldorf am Inn

    Mühldorf, 84453

  • Gemeinschaftspraxis Mietaschk, Bilderling, Kaiser, Tato

    München, Bavaria, 80331

  • Praxis Dr. Kähler

    Rostock, 18059

  • Praxis für Gefäßmedizin am Tegernsee

    Rottach-Egern, 83700

  • Venenzentrum Wiesbaden

    Wiesbaden, 65183

Other trials in Germany

About this study

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

The purpose of this study is to evaluate the efficacy and safety of rivaroxaban versus fondaparinux in the treatment of superficial vein thrombosis (SVT).

Read the 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

Being tested
Rivaroxaban, Fondaparinux
Keywords
superficial vein thrombosis, thrombosis, SVT
Medical subject headings
Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RivaroxabanDrug

    Also called Xarelto

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

  • FondaparinuxDrug

    Also called Arixtra

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

Study groups in NCT01499953
Study groupRoleWhat they receive
RivaroxabanExperimentalRivaroxaban for 45 days oral dose: 10 mg OD
Receives: Drug: Rivaroxaban
FondaparinuxActive comparatorFondaparinux for 45 days subcutaneous application: 2,5 mg OD
Receives: Drug: Fondaparinux

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Objectively Confirmed VTE Complications

    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.

    Measured: 45 +/- 5 days

Secondary outcomes (3)

  1. Composite Primary Efficacy Outcome

    For this, secondary efficacy outcomes were the composite primary efficacy outcome up to Day 90 and the following outcomes up to Day 45 and Day 90: each component of the primary efficacy outcome, the rate of major VTE (composite of symptomatic pulmonary embolism or symptomatic proximal DVT or VTE-related death) and the rates of surgery for SVT.

    Measured: 90 +/- 10 days

  2. Rate of Major VTE

    composite of:

    • symptomatic pulmonary embolism
    • symptomatic proximal DVT
    • VTE-related death

    Measured: 90 +/-10 days

  3. Rates of Surgery for SVT

    Measured: 90 +/-10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2011 (estimated)
  2. Study startApr 2012
  3. Primary completionMay 2016
  4. Study completionMay 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
472 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01499953
Sponsor's protocol ID
SURPRISE-2011
Status last verified
Jul 2022
First submitted
19 Dec 2011
Last updated
15 May 2023
Data monitoring committee
Yes

Publications

  • Kearon C, Carrier M, Gu CS, Schulman S, Bates SM, Kahn SR, Chagnon I, Nguyen DT, Wu C, Rudd-Scott L, Julian JA. Rivaroxaban Compared to Placebo for the Treatment of Leg Superficial Vein Thrombosis: A Randomized Trial. Semin Thromb Hemost. 2020 Nov;46(8):977-985. doi: 10.1055/s-0040-1718891. Epub 2020 Dec 23.

    PubMed 33368114

  • Beyer-Westendorf J, Schellong SM, Gerlach H, Rabe E, Weitz JI, Jersemann K, Sahin K, Bauersachs R; SURPRISE investigators. Prevention of thromboembolic complications in patients with superficial-vein thrombosis given rivaroxaban or fondaparinux: the open-label, randomised, non-inferiority SURPRISE phase 3b trial. Lancet Haematol. 2017 Mar;4(3):e105-e113. doi: 10.1016/S2352-3026(17)30014-5. Epub 2017 Feb 16.

    PubMed 28219692

  • Werth S, Bauersachs R, Gerlach H, Rabe E, Schellong S, Beyer-Westendorf J. Superficial vein thrombosis treated for 45 days with rivaroxaban versus fondaparinux: rationale and design of the SURPRISE trial. J Thromb Thrombolysis. 2016 Aug;42(2):197-204. doi: 10.1007/s11239-016-1354-3.

    PubMed 26973347

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rivaroxaban and Fondaparinux in people with Superficial Vein Thrombosis, run by GWT-TUD GmbH at 23 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Objectively Confirmed VTE Complications (time frame: 45 +/- 5 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01499953, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.

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