Superficial Vein Thrombosis (SVT) Treated With Rivaroxaban Versus Fondaparinux

July 18, 2022 updated by: GWT-TUD GmbH

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
472

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10787
        • Franziskus-Krankenhaus Berlin
      • Berlin, Germany, 12043
        • MVZ Ramdohr, Praxis für Cardiovaskulär- u. Ultraschalldiagnostik
      • Berlin, Germany, 12627
        • Praxis für Chirurgie & Gefäßmedizin
      • Darmstadt, Germany, 64283
        • Klinikum Darmstadt GmbH
      • Eschwege, Germany, 37269
        • Gemeinschaftspraxis Eggeling und Winter
      • Hamburg, Germany, 22559
        • Asklepios Westklinikum Hamburg
      • Heidelberg, Germany, 69120
        • Universitatsklinikum Heidelberg
      • Hoppegarten, Germany, 15366
        • Internistische Praxisgemeinschaft
      • Karlsbach, Germany, 76307
        • Akademie für Gefäßkrankheiten e.V.
      • Köln, Germany, 50670
        • Praxis für Allgemeinmedizin und Phlebologie
      • Leipzig, Germany
        • Universitätsklinikum Leipzig AöR Innere Medizin - Angiologische Ambulanz
      • Lübeck, Germany, 23538
        • Universitätsklinikum Schleswig-Holstein, Campus Lübeck
      • Magdeburg, Germany, 39112
        • Praxis Dr. Franke
      • Mühldorf Am Inn, Germany, 84453
        • Kardiologie Mühldorf am Inn
      • Rostock, Germany, 18059
        • Praxis Dr. Kähler
      • Rottach-Egern, Germany, 83700
        • Praxis für Gefäßmedizin am Tegernsee
      • Wiesbaden, Germany, 65183
        • Venenzentrum Wiesbaden
    • Baden-Württemberg
      • Freiburg, Baden-Württemberg, Germany, 79098
        • Hautarztpraxis
    • Bayern
      • München, Bayern, Germany, 80331
        • Gemeinschaftspraxis Mietaschk, Bilderling, Kaiser, Tato
    • Nordrhein-Westfalen
      • Baesweiler, Nordrhein-Westfalen, Germany, 52499
        • Chriurgische Praxisklinik
    • Sachsen
      • Dresden, Sachsen, Germany, 01067
        • Krankenhaus Dresden-Friedrichstadt
      • Dresden, Sachsen, Germany, 01307
        • Universitätsklinikum Dresden
      • Görlitz, Sachsen, Germany, 02826
        • Oberlausitz-Gefäßpraxis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
45 +/- 5 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Composite Primary Efficacy Outcome
Time Frame: 90 +/- 10 days
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.
90 +/- 10 days
Rate of Major VTE
Time Frame: 90 +/-10 days

composite of:

  • symptomatic pulmonary embolism
  • symptomatic proximal DVT
  • VTE-related death
90 +/-10 days
Rates of Surgery for SVT
Time Frame: 90 +/-10 days
90 +/-10 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Major Bleeding (Main Safety Outcome)
Time Frame: 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.
45 +/- 5 days
Clinically Relevant Non-major, Minor and Total (Any) Bleeding
Time Frame: 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)
45 +/- 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GWT-TUD GmbH

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bayer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jan Beyer-Westendorf, MD, on behalf of GWT-TUD GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 26, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SURPRISE-2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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