Last updated: 11/07/2018 16:16:09
A multicentre, randomized, double-blind study comparing the efficacy and safety of once daily (o.d.) Org31540/SR90107A versus twice daily (b.i.d.) enoxaparin in the initial treatment of acute symptomatic deep vein thrombosis (DVT) (MATISSE-DVT)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A multicentre, randomized, double-blind study comparing the efficacy and safety of once daily (o.d.) Org31540/SR90107A versus twice daily (b.i.d.) enoxaparin in the initial treatment of acute symptomatic deep vein thrombosis (DVT) (MATISSE-DVT)
Trial description: A multicentre, randomized, double-blind study comparing the efficacy and safety of once daily (o.d.) Org31540/SR90107A versus twice daily (b.i.d.) enoxaparin in the initial treatment of acute symptomatic deep vein thrombosis (DVT) (MATISSE-DVT)
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:
Not applicable
Time perspective:
Not applicable
Clinical publications:
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
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
Abstract: Initial outpatient treatment of venous thromboembolism with fondaparinux (arixtra®): the matisse trials. Buller, H 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-dvt trial, a randomized, double-blind study comparing once-daily fondaparinux (arixtra®) with the low-molecular-weight heparin (LMWH) enoxaparin, twice daily, in the initial treatment of symptomatic deep-vein thrombosis (dvt). 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
Buller HR. Fondaparinux or enoxaparin for the initial treatment of symptomatic deep venous thrombosis: a randomized trial. Ann Intern Med. 2004 Jun 1;140 (11):867-73.
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, Piovella, European Association of Hospital Pharmacists, Sevilla, Spain, March 17-19, 2004.
Fondaparinux in the treatment of deep-vein thrombosis and pulmonary embolism, Buller, European Hematology Association, Geneva, Switzerland, June 10-13, 2004.
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
Thrombosis, Venous
Product
fondaparinux sodium
Collaborators
Not applicable
Study date(s)
April 2000 to October 2001
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
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2001-18-10
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
Not applicable
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