Last updated: 11/07/2018 02:36:09
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 surgeryFONDACAST
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Number of participants with venous thromboembolism (VTE) or death up to the time of complete mobilization
Timeframe: Day 1 to complete mobilization plus 2 days (average of 35.9 study days)
Secondary outcomes:
Number of participants with any adjudicated components of VTE, asymptomatic DVT, symptomatic DVT, symptomatic PE, and death
Timeframe: Day 1 to complete mobilization plus 2 days (average of 35.7 study days)
Number of participants with confirmed VTE and death up to the final visit or contact
Timeframe: Day 1 to 5 weeks (plus or minus 1 week) after complete mobilization (average of 67.8 study days)
Number of participants with major bleeding from Day 1 to complete mobilization and from Day 1 up to the final visit or contact
Timeframe: 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)
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
Timeframe: 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)
Number of participants with minor bleeding from Day 1 to complete mobilization and from Day 1 up to the final visit or contact
Timeframe: 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)
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
Timeframe: 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)
Interventions:
Drug: Fondaparinux sodium
Drug: Nadroparin
Enrollment:
1351
Observational study model:
Not applicable
Primary completion date:
2011-04-07
Time perspective:
Not applicable
Clinical publications:
CM Samama,N Lecoules, G. Kierzek, YE Claessens, B Riou, N Rosencher, P Mismetti, A Sautet, K Apartsin, M. Jonas, M-T Barrellier, R Caeiro, AH van der Veen, PM Roy,. Comparison of fondaparinux with low-molecular-weight heparin for VTE prevention in patients requiring rigid or semi-rigid immobilisation for isolated non-surgical below-knee injury. J Thromb Haemost. 2013;11(10):1833-43
Medical condition
Thrombosis, Venous
Product
fondaparinux sodium, nadroparin calcium
Collaborators
Not applicable
Study date(s)
December 2008 to July 2011
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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
- 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,
Inclusion and exclusion criteria
Inclusion criteria:
- 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
Exclusion criteria:
- 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,
- 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 location(s)
Location
GSK Investigational Site
Sainte Colombe Les Vienne, France, 69560
Status
Study Complete
Location
GSK Investigational Site
Orbassano (TO), Piemonte, Italy, 10043
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Conegliano (TV), Veneto, Italy, 31015
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Moers, Nordrhein-Westfalen, Germany, 47441
Status
Study Complete
Location
GSK Investigational Site
Muenchen, Bayern, Germany, 80335
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Zerbst, Sachsen-Anhalt, Germany, 39261
Status
Study Complete
Location
GSK Investigational Site
San Sebastián de los Reyes/Madrid, Spain
Status
Study Complete
Location
GSK Investigational Site
Hamburg, Hamburg, Germany, 20246
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Torrelodones/Madrid, Spain, 28250
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Dresden, Sachsen, Germany, 01307
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bologna, Emilia-Romagna, Italy, 40136
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Wiesbaden, Hessen, Germany, 65191
Status
Terminated/Withdrawn
Location
GSK Investigational Site
MAASTRICHT, Netherlands, 6229 HX
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Majadahonda/Madrid, Spain, 28220
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Udine, Friuli-Venezia-Giulia, Italy, 33100
Status
Study Complete
Location
GSK Investigational Site
Gevelsberg, Nordrhein-Westfalen, Germany, 58285
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Luebeck, Schleswig-Holstein, Germany, 23538
Status
Study Complete
Location
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69120
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2011-04-07
Actual study completion date
2011-04-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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