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Thrombosis, VenousPhase 3FONDACASTNCT00843492

A Study to Evaluate the Efficacy and Safety of Fondaparinux for the Prevention of Venous Blood Clots in Patients With a Plaster Cast or Other Type of Immobilization for a Below-knee Injury Not Needing Surgery

A Phase 3 study testing Fondaparinux sodium and Nadroparin in people with Thrombosis, Venous, run by GlaxoSmithKline at 122 sites in 6 countries.

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 fondaparinux in comparison with a heparin (nadroparin) in preventing deep vein thrombosis (blood clots in the leg veins), whether symptomatic or detected by ultrasound, and pulmonary embolism (blood clots that migrate to the lungs) in patients with… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thrombosis, Venous
What is being tested?
Fondaparinux sodium and Nadroparin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,351 participants
Where
122 sitesin 6 countries
Study dates
Dec 2008to Jun 2010
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

  • Requiring rigid or semi-rigid immobilization (e.g. with a plaster cast or brace) for at least 21 days and up to 45 days because of isolated non-surgical below-knee injury
  • With a no weight-bearing recommendation at the time of inclusion (partial weight bearing is permitted e.g. crutches, walking cast, relief shoes),
  • Presenting at least one of the following risk factors for venous thromboembolism: below-knee fracture or Achilles tendon rupture, age ≥40 years, body mass index > 30 kg/m2, oestrogen-containing hormonal replacement therapy or oral contraception, active cancer (treatment ongoing or stopped for less than one year), history of VTE, congenital or acquired hypercoagulable state,
  • Requiring thromboprophylaxis according to the Investigator's judgement up to complete mobilization (corresponding to cast or brace removal)
  • Able and willing to provide written informed consent

Who cannot join

  • Delay between injury and randomization greater than two days,
  • Treatment with antithrombotic or anticoagulant therapy, including low-dose anticoagulation, for more than 2 days prior to randomization,
  • Anticoagulant therapy required or likely to be required during the study period for another reason (e.g. planned surgery justifying pharmacological thromboprophylaxis, curative dose for treatment of VTE, etc.)
  • Known hypersensitivity to fondaparinux or nadroparin or their excipient,
  • Known history of heparin-induced thrombocytopenia,
  • Women of childbearing potential not using a reliable contraceptive method throughout the study period,
Show all 28Show fewer
  • Women pregnant or breast-feeding during the study period.
  • Active, clinically significant bleeding,
  • Clinically significant bleeding within the past six months,
  • Major surgery within the previous three months,
  • Intraocular (other than cataract), spinal, and/or brain surgery within the previous twelve months,
  • Haemorrhagic stroke within the previous twelve months,
  • Severe head injury within the previous three months,
  • Documented congenital or acquired bleeding tendency/disorder(s),
  • Previous (within 12 months) or active or currently treated peptic ulcer disease,
  • Uncontrolled arterial hypertension (systolic blood pressure over 180 mm Hg or diastolic blood pressure over 110 mm Hg),
  • Treatment with more than one antiplatelet agents (e.g. clopidogrel and aspirin) at any dose,
  • Need for chronic aspirin at doses≥ 325 mg or chronic NSAIDs,
  • Bacterial endocarditis,
  • Severe hepatic impairment,
  • Calculated creatinine clearance < 30 mL/min,
  • Thrombocytopenia ( <100x10_9/L)
  • Body weight < 50 kg.
  • Any condition that could prevent the patient from providing written informed consent or from adhering to study treatment,
  • Life expectancy under six months,
  • Participation in any study using an investigational drug during the previous three months,
  • Patient in whom V3 is unlikely to be feasible (e.g. patient moving house),
  • In France, a subject will not be eligible for inclusion in this study if not either affiliated to or a beneficiary of a social security system. This is an additional exclusion criterion only applying to subjects enrolled in France.

Trial locations and contacts

122 sites in 6 countries.

122 sites in 6 countries

France33 sites

  • GSK Investigational Site

    Agen, 47923

  • GSK Investigational Site

    Angers, 49100

  • GSK Investigational Site

    Antony, 92166

  • GSK Investigational Site

    Argenteuil, 95107

  • GSK Investigational Site

    Beauvais, 60021

  • GSK Investigational Site

    Bobigny, 93009

  • GSK Investigational Site

    Brest, 29609

  • GSK Investigational Site

    Cergy-Pontoise, 95303

  • GSK Investigational Site

    Clermont-Ferrand, 63000

  • GSK Investigational Site

    Colmar, 68024

  • GSK Investigational Site

    Créteil, 94010

  • GSK Investigational Site

    Grenoble, 38043

  • GSK Investigational Site

    Lille, 59037

  • GSK Investigational Site

    Lyon, 69275

  • GSK Investigational Site

    Lyon, 69365

  • GSK Investigational Site

    Lyon, 69437

  • GSK Investigational Site

    Mougins, 06250

  • GSK Investigational Site

    Nantes, 44093

  • GSK Investigational Site

    Orthez, 64301

  • GSK Investigational Site

    Paris, 75015

  • GSK Investigational Site

    Paris, 75181

  • GSK Investigational Site

    Paris, 75571

  • GSK Investigational Site

    Paris, 75651

  • GSK Investigational Site

    Paris, 75679

  • GSK Investigational Site

    Pringy, 74374

  • GSK Investigational Site

    Rennes, 35033

  • GSK Investigational Site

    Roanne, 42300

  • GSK Investigational Site

    Rouen, 76031

  • GSK Investigational Site

    Saint-Pierre, 97448

  • GSK Investigational Site

    Sainte Colombe Les Vienne, 69560

  • GSK Investigational Site

    Saintes, 17108

  • GSK Investigational Site

    Toulouse, 31059

  • GSK Investigational Site

    Valenciennes, 59300

Other trials in France

Spain30 sites

  • GSK Investigational Site

    A Coruña, 15006

  • GSK Investigational Site

    Aravaca, 28023

  • GSK Investigational Site

    Avilés/Asturias, 33400

  • GSK Investigational Site

    Barcelona, 08006

  • GSK Investigational Site

    Barcelona, 08036

  • GSK Investigational Site

    Castellon, 12004

  • GSK Investigational Site

    Córdoba, 14004

  • GSK Investigational Site

    Don Benito/Badajoz, 06400

  • GSK Investigational Site

    Ferrol. La Coruña, 15405

  • GSK Investigational Site

    Getafe/Madrid, 28905

  • GSK Investigational Site

    Jaén, 23007

  • GSK Investigational Site

    Linares, 23700

  • GSK Investigational Site

    Lugo, 27004

  • GSK Investigational Site

    Madrid, 28006

  • GSK Investigational Site

    Madrid, 28034

  • GSK Investigational Site

    Madrid, 28040

  • GSK Investigational Site

    Madrid, 28041

  • GSK Investigational Site

    Majadahonda/Madrid, 28220

  • GSK Investigational Site

    Mondragón - Guipúzcoa, 20500

  • GSK Investigational Site

    Ourense, 32005

  • GSK Investigational Site

    Palencia, 340014

  • GSK Investigational Site

    Palma de Mallorca, 07010

  • GSK Investigational Site

    Pozoblanco/Córdoba, 14400

  • GSK Investigational Site

    San Sebastián de Los Reyes/Madrid

  • GSK Investigational Site

    Santiago de Compostela, 15706

  • GSK Investigational Site

    Seville, 41071

  • GSK Investigational Site

    Torrelodones/Madrid, 28250

  • GSK Investigational Site

    Torrevieja, 03184

  • GSK Investigational Site

    Valdemoro/Madrid, 28340

  • GSK Investigational Site

    Vigo/Pontevedra, 36200

Other trials in Spain

Russia21 sites

  • GSK Investigational Site

    Barnaul, 656024

  • GSK Investigational Site

    Irkutsk, 664003

  • GSK Investigational Site

    Kemerovo, 650002

  • GSK Investigational Site

    Kursk, 305035

  • GSK Investigational Site

    Moscow, 125299

  • GSK Investigational Site

    Novosibirsk, 630117

  • GSK Investigational Site

    Perm, 614036

  • GSK Investigational Site

    Ryazan, 390026

  • GSK Investigational Site

    Saint Petersburg, 198260

  • GSK Investigational Site

    Saint Petersburgh, 192242

  • GSK Investigational Site

    Samara, 443010

  • GSK Investigational Site

    Samara, 443095

  • GSK Investigational Site

    Stavropol, 355030

  • GSK Investigational Site

    Tomsk, 634063

  • GSK Investigational Site

    Tver', 170036

  • GSK Investigational Site

    Tyumen, 625023

  • GSK Investigational Site

    Ufa, 450000

  • GSK Investigational Site

    Yaroslavl, 150003

  • GSK Investigational Site

    Yaroslavl, 150023

  • GSK Investigational Site

    Yekaterinburg, 620039

  • GSK Investigational Site

    Yekaterinburg, 620102

Other trials in Russia

Germany20 sites

  • GSK Investigational Site

    Altenburg, Thuringia, 04600

  • GSK Investigational Site

    Berlin, State of Berlin, 10559

  • GSK Investigational Site

    Berlin, State of Berlin, 12627

  • GSK Investigational Site

    Berlin, State of Berlin, 13353

  • GSK Investigational Site

    Dresden, Saxony, 01187

  • GSK Investigational Site

    Dresden, Saxony, 01307

  • GSK Investigational Site

    Erlangen, Bavaria, 91054

  • GSK Investigational Site

    Gevelsberg, North Rhine-Westphalia, 58285

  • GSK Investigational Site

    Hamburg, Free and Hanseatic City of Hamburg, 20246

  • GSK Investigational Site

    Hamburg, Free and Hanseatic City of Hamburg, 22415

  • GSK Investigational Site

    Hanover, Lower Saxony, 30625

  • GSK Investigational Site

    Heidelberg, Baden-Wurttemberg, 69120

  • GSK Investigational Site

    Lübeck, Schleswig-Holstein, 23538

  • GSK Investigational Site

    Moers, North Rhine-Westphalia, 47441

  • GSK Investigational Site

    Munich, Bavaria, 80335

  • GSK Investigational Site

    Munich, Bavaria, 80339

  • GSK Investigational Site

    Schmiedeberg, Saxony, 01762

  • GSK Investigational Site

    Wiesbaden, Hesse, 65191

  • GSK Investigational Site

    Zerbst, Saxony-Anhalt, 39261

  • GSK Investigational Site

    Zwickau, Saxony, 08060

Other trials in Germany

Italy12 sites

  • GSK Investigational Site

    Bergamo, Lombardy, 24128

  • GSK Investigational Site

    Bologna, Emilia-Romagna, 40136

  • GSK Investigational Site

    Catania, Sicily, 95126

  • GSK Investigational Site

    Conegliano (TV), Veneto, 31015

  • GSK Investigational Site

    Genoa, Liguria, 16132

  • GSK Investigational Site

    Latina, Lazio, 04100

  • GSK Investigational Site

    Milan, Lombardy, 20161

  • GSK Investigational Site

    Orbassano (TO), Piedmont, 10043

  • GSK Investigational Site

    Padova, Veneto, 35128

  • GSK Investigational Site

    Rome, Lazio, 00141

  • GSK Investigational Site

    Siena, Tuscany, 53100

  • GSK Investigational Site

    Udine, Friuli Venezia Giulia, 33100

Other trials in Italy

Netherlands6 sites

  • GSK Investigational Site

    Amersfoort, 3818 ES

  • GSK Investigational Site

    Eindhoven, 5623 EJ

  • GSK Investigational Site

    Maastricht, 6229 HX

  • GSK Investigational Site

    Sittard-geleen, 6162 BG

  • GSK Investigational Site

    Utrecht, 3582 KE

  • GSK Investigational Site

    Venlo, 5912 BL

Other trials in Netherlands

About this study

Official title: A Multicentre, Randomized, Open-label Study to Evaluate the Efficacy andSafety of Fondaparinux Versus Low Molecular Weight Heparin(Nadroparin) in Patients Requiring Rigid or Semi-rigid Immobilization for at Least 21 Days and up to 45 Days Because of Isolated Non-surgical Below-Knee Injury

The purpose of this study is to evaluate the efficacy and safety of fondaparinux in comparison with a heparin (nadroparin) in preventing deep vein thrombosis (blood clots in the leg veins), whether symptomatic or detected by ultrasound, and pulmonary embolism (blood clots that migrate to the lungs) in patients with leg injuries below the knee that require a cast or other type of immobilization but not surgery.

Read the detailed description

The study is designed to evaluate the efficacy and safety of fondaparinux sodium 2.5 mg (1.5 mg in patients with a creatinine clearance between 30 and 50 mL/min) once daily versus Low-Molecular Weight Heparin (nadroparin 2850 anti-Xa IU, 0.3 mL, once daily), with respect to the occurrence of venous thromboembolism, death and bleeding complications in patients requiring rigid or semi-rigid immobilization for at least 21 days and up to 45 days because of isolated nonsurgical below-knee injury. Treatment will be continued up to complete mobilization, e.g. plaster cast or brace removal, for a maximum of 45 days. The study will be a European, multicentre, randomized, open-label, controlled, two-parallel-group, phase III study in 1350 male and female patients 18 years of age or older, presenting with at least one additional major risk factor for VTE. After randomization (Day 1), subjects will receive subcutaneously, once daily, either fondaparinux or nadroparin up to complete mobilization. After cast or brace removal, a systematic, bilateral compression ultrasound will be done in all patients. Patients will be contacted five weeks (± one week) after complete mobilization. All suspected venous thromboembolic events, including asymptomatic deep vein thrombosis, all deaths, and all bleeding events (with the exception of certain types of minor bleeding events defined in the protocol) will be reviewed by an independent adjudication committee blind to treatment assignment.

Being tested
Fondaparinux sodium, Nadroparin
Keywords
deep vein thrombosis, immobilization, nadroparin, isolated lower-extremity injuries distal to the knee, plaster cast, non-surgical leg injury, venous thromboembolism, bleeding events, fondaparinux
Medical subject headings
Venous Thrombosis, Venous Thromboembolism

What participants receive

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

  • Fondaparinux sodiumDrug

    After randomization (Day 1), subjects will receive subcutaneously once daily fondaparinux 2.5 mg [0.5mL] (1.5 mg [0.3mL] in patients with creatinine clearance between 30 and 50 mL/min) for at least 21 Days, up to complete mobilization, corresponding to cast or brace removal. The maximal duration of treatment is 45 days.

  • NadroparinDrug

    After randomization (Day 1), subjects will receive subcutaneously once daily nadroparin 2850 anti-Xa IU (0.3 mL) for at least 21 Days, up to complete mobilization, corresponding to cast or brace removal. The maximal duration of treatment is 45 days.

Study groups in NCT00843492
Study groupRoleWhat they receive
NadroparinActive comparatorAfter randomization (Day 1), subjects will receive subcutaneously once daily nadroparin 2850 anti-Xa IU (0.3 mL) for at least 21 Days, up to complete mobilization, corresponding to cast or brace removal. The maximal duration of treatment is 45 days. Patients will then be followed up to five weeks (± one week) after the cast or brace removal.
Receives: Drug: Nadroparin
FondaparinuxExperimentalAfter randomization (Day 1), subjects will receive subcutaneously, once daily, fondaparinux 2.5 mg (1.5 mg in patients with creatinine clearance between 30 and 50 mL/min) for at least 21 Days, up to complete mobilization, corresponding to cast or brace removal. The maximal duration of treatment is 45 days. Patients will then be followed up to five weeks (± one week) after the cast or brace removal.
Receives: Drug: Fondaparinux sodium

What is being measured

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

  1. Number of Participants With Venous Thromboembolism (VTE) or Death up to the Time of Complete Mobilization

    VTE is defined as asymptomatic deep vein thrombosis (DVT: the formation of a blood clot in a deep vein) detected by systematic compression ultrasonography, symptomatic DVT, or symptomatic fatal or non-fatal pulmonary embolism (PE). An embolism is a clot in the blood that forms and blocks a blood vessel. A pulmonary embolism is a blood clot that has travelled from elsewhere in the body through the blood stream to block the main artery of the lung or one of its branches. All venous thromboembolic events and deaths were adjudicated by the independent Central Adjudication Committee (CAC).

    Measured: Day 1 to complete mobilization plus 2 days (average of 35.9 study days)

Secondary outcomes (6)

  1. Number of Participants With Any Adjudicated Components of VTE, Asymptomatic DVT, Symptomatic DVT, Symptomatic PE, and Death

    All components of the primary endpoint were considered separately: any VTE; symptomatic (providing no evidence of disease existence) DVT (the formation of a blood clot in a deep vein) detected by systematic compression ultrasonography; symptomatic(providing evidence of disease existence) DVT; symptomatic PE (blood clot that has travelled from elsewhere in the body through the blood stream to block the main artery of the lung of one of its branches); and death.

    Measured: Day 1 to complete mobilization plus 2 days (average of 35.7 study days)

  2. Number of Participants With Confirmed VTE and Death up to the Final Visit or Contact

    The number of participants with VTE (defined as asymptomatic deep vein thrombosis [DVT: the formation of a blood clot in a deep vein] detected by systematic compression ultrasonography, symptomatic DVT, or symptomatic fatal or non-fatal pulmonary embolism [PE]) and death was assessed. An embolism is a clot in the blood that forms and blocks a blood vessel. A PE is a blood clot that has travelled from elsewhere in the body through the blood stream to block the main artery of the lung or one of its branches.

    Measured: Day 1 to 5 weeks (plus or minus 1 week) after complete mobilization (average of 67.8 study days)

  3. Number of Participants With Major Bleeding From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact

    Major bleeding is defined as bleeding that results in a fatality, symptomatic bleeding in a critical area or organ, bleeding causing a fall in hemoglobin level of 20 grams/liter (1.24 millimoles/liter) or more compared with the pre-randomization hemoglobin level, or bleeding that leads to a transfusion of two or more units of whole blood or red blood cells. All episodes of bleeding were adjudicated by an independent CAC. The committee members were unaware of the participants' treatment assignment.

    Measured: Day 1 to complete mobilization plus 4 days (average of 37.7 study days); Day 1 up to final visit or contact (average of 66.3 study days)

  4. Number of Participants With Clinically Relevant Non-major Bleeding From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact

    Clinically relevant non-major bleeding that does not qualify as major is defined as bleeding leading to treatment discontinuation, and/or epistaxis (bleeding through the nose) that lasts for more than 5 minutes or necessitates intervention (e.g., packing), spontaneous macroscopic haematuria (blood in urine), gastrointestinal haemorrhage, haemoptysis (coughing up blood), or subcutaneous haematoma (localized collection of blood) > 100 centimeters squared. All episodes of bleeding were adjudicated by an independent CAC. The committee members were unaware of the participants' treatment assignment.

    Measured: Day 1 to complete mobilization plus 4 days (average of 37.7 study days); Day 1 up to final visit or contact (average of 66.3 study days)

  5. Number of Participants With Minor Bleeding From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact

    Minor bleeding is defined as clinically overt bleeding events that do not meet the criteria for major or clinically relevant non-major bleeding. All episodes of bleeding were adjudicated by an independent CAC. The committee members were unaware of the participants' treatment assignment.

    Measured: Day 1 to complete mobilization plus 4 days (average of 37.7 study days); Day 1 up to final visit or contact (average of 66.3 study days)

  6. Participants With Any Incidence of Any Bleeding Event as Adjudicated by a CAC) From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact

    All episodes of bleeding, except minor bruising, skin hematomas not greater than 5 centimeters in diameter, self-limited epistaxis (bleeding through the nose), and self-limited gingival (gum) bleeding, were adjudicated by an independent CAC. The committee members were unaware of the participants' treatment assignment.

    Measured: Day 1 to complete mobilization plus 4 days (average of 37.7 study days); Day 1 up to final visit or contact (average of 66.3 study days)

Timeline

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

  1. First posted13 Feb 2009 (estimated)
  2. Study startDec 2008
  3. Primary completionJan 2010
  4. Study completionJun 2010

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,351 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00843492
Sponsor's protocol ID
109350
Acronym
FONDACAST
Status last verified
Feb 2014
First submitted
11 Dec 2008
Last updated
16 Mar 2016
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fondaparinux sodium and Nadroparin in people with Thrombosis, Venous, run by GlaxoSmithKline at 122 sites in 6 countries.

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 5 inclusion and 28 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 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 122 sites in France, Spain, Russia, Germany, Italy and 1 more country. 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 18 Jul 2012). 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?

Number of Participants With Venous Thromboembolism (VTE) or Death up to the Time of Complete Mobilization (time frame: Day 1 to complete mobilization plus 2 days (average of 35.9 study 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 NCT00843492.

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 16 Mar 2016.

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