Last updated: 11/07/2018 15:11:01
A multicentre, randomized, open-label study comparing the efficacy and safety of once daily (o.d.) Org31540/SR90107A versus adjusted dose intravenous (i.v.) unfractionated heparin (UFH) in the initial treatment of acute symptomatic pulmonary embolism (PE) (MATISSE-PE)
Clinicaltrials.gov ID
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EudraCT ID
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EU CT Number
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Trial status
Study complete
Study complete
Trial overview
Official title: A multicentre, randomized, open-label study comparing the efficacy and safety of once daily (o.d.) Org31540/SR90107A versus adjusted dose intravenous (i.v.) unfractionated heparin (UFH) in the initial treatment of acute symptomatic pulmonary embolism (PE) (MATISSE-PE)
Trial description: A multicentre, randomized, open-label study comparing the efficacy and safety of once daily (o.d.) Org31540/SR90107A versus adjusted dose intravenous (i.v.) unfractionated heparin (UFH) in the initial treatment of acute symptomatic pulmonary embolism (PE) (MATISSE-PE)
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
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Time perspective:
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Clinical publications:
Abstract: Fondaparinux in the initial treatment of pulmonary embolism in overweight patients. Piovella, F. 21st World Congress of the International Union of Angiology 5/22/2004 Rome; Italy
Abstract: Fondaparinux in the treatment of deep-vein thrombosis and pulmonary embolism. H.R. Buller, '9th Congress of the European Haematology Association 6/10/2004 Geneva; Switzerland
Abstract: Fondaparinux, a pentasaccharide vs unfractionated heparin (uh) or low molecular weight heparin (lmwh) for pulmonary embolism (pe) or deep vein thrombosis (dvt): the matisse trials. B.L. Davidson, the Matisse Steering Committee and Investigators. 99th International Conference of the American Thoracic Society 5/16/2003 Seattle, WA; USA
Abstract: Initial outpatient treatment of pulmonary embolism (pe) with fondaparinux (arixtra®). Buller, H. 21st World Congress of the International Union of Angiology 5/22/2004 Rome; Italy
Abstract: Initial outpatient treatment of pulmonary embolism with fondaparinux (arixtra@): the matisse-pe trial. F. Piovella, Matisse investigators 9th Congress of the European Haematology Association 6/10/2004 Geneva; Switzerland
Abstract: Initial outpatient treatment of venous thromboembolism with fondaparinux (arixtra®): the matisse trials. Buller, H 2 1 20th Congress of the International Society on Thrombosis and Haemostasis held jointly with the 51st Annual Meeting of the Scientific and Standardization Committee 8/6/2005 Sydney; Australia
Abstract: The Matisse-PE trial, a multicenter, randomized, open study comparing once-daily fondaparinux (arixtra) with adjusted-dose intravenous unfractionated heparin (ufh) in the initial treatment of acute symptomatic pulmonary embolism (pe). The Matisse Investigators 19th Congress of the International Society on Thrombosis and Haemostasis and 49th Annual Scientific and Standardisation Committee Meeting 7/12/2003 Birmingham; UK
Büller, H. Subcutaneous fondaparinux versus intravenous unfractionated heparin in the initial treatment of pulmonary embolism. N Engl J Med 2003;349:1695-702.
Efficacy and safety of fondaparinux (Arixtra) in the initial treatment of venous thromboembolism in obese patients, Buller, American Society of Haematology, San Diego, USA, December 4-7, 2004. ( oral)
Fondaparinux (Arixtra®) is at least as effective and as safe as unfractionated heparin or low-molecular-weight heparin in the initial treatment of symptomatic venous thromboembolism): The MATISSE trials European Association of Hospital Pharmacists March 17-19, 2004 Sevilla, Spain
Fondaparinux in the initial treatment of pulmonary embolism in overweight patients, Piovella, International Union of Angiology, Rome, Italy, May 22-26, 2004. ( oral)
Fondaparinux in the treatment of deep-vein thrombosis and pulmonary embolism, Buller, European Hematology Association, Geneva Switzerland, June 10-13, 2004. ( poster)
Fondaparinux in the treatment of deep-vein thrombosis and pulmonary embolism, Buller, International Union of Angiology, Rome, Italy, May 22-26, 2004. ( oral)
Fondaparinux in the treatment of deep-vein thrombosis and pulmonary embolism. European Hematology Association June 10-13, 2004 Geneva, Switzerland
Initial outpatient treatment of pulmonary embolism with fondaparinux (Arixtra®), Buller, International Union of Angiology, Rome, Italy, May 22-26, 2004. ( oral)
Initial outpatient treatment of pulmonary embolism with fondaparinux (Arixtra®): The MATISSE-PE trial European Hematology Association June 10-13, 2004 Geneva, Switzerland
Initial outpatient treatment of pulmonary embolism with fondaparinux (Arixtra®): The MATISSE-PE trial, Piovella, European Hematology Association, Geneva, Switzerland, June 10-13, 2004. ( poster)
Initial outpatient treatment of venous thromboembolism with fondaparinux (Arixtra): The MATISSE trials, Buller, American Society of Haematology, San Diego, USA, December 4-7, 2004. ( oral)
Medical condition
Pulmonary Embolism
Product
Not applicable
Collaborators
Not applicable
Study date(s)
N/A to Invalid Date
Type
Not applicable
Phase
3
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
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Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
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
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