Last updated: 04/01/2020 19:00:06

A multicenter, multinational, randomized, double-blind study to compare the efficacy and safety of fondaparinux sodium (Org31540/SR90107A) with dalteparin (Fragmin) in the prevention of venous thromboembolic events in high-risk abdominal surgery (PEGASUS)

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GSK study ID
EFC3557
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Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A multicenter, multinational, randomized, double-blind study to compare the efficacy and safety of fondaparinux sodium (Org31540/SR90107A) with dalteparin (Fragmin) in the prevention of venous thromboembolic events in high-risk abdominal surgery (PEGASUS)
Trial description: A multicenter, multinational, randomized, double-blind study to compare the efficacy and safety of fondaparinux sodium (Org31540/SR90107A) with dalteparin (Fragmin) in the prevention of venous thromboembolic events in high-risk abdominal surgery (PEGASUS)
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: A randomized double-blind study to compare the efficacy and safety of fondaparinux with dalteparin in the prevention of venous thromboembolism after high-risk abdominal surgery: the pegasus study. Agnelli G., Bergqvistt D. Cohen A. Gallus A. Gent T M. 19th Congress of the International Society on Thrombosis and Haemostasis and 49th Annual Scientific and Standardisation Committee Meeting 7/12/2003 Birmingham; UK
Abstract: A randomized double-blind study to compare the efficacy and safety of postoperative fondaparinux (arixtra®) and preoperative dalteparin in the prevention of venous thromboembolism after high-risk abdominal surgery: the pegasus study. Agnelli, Giancarlo, Bergqvist, David, Cohen, Alexander, Gallus, Alexander S., and Gent, Michael 45th Annual Meeting and Exposition of the American Society of Hematology 12/5/2003 San Diego, CA; USA
Agnelli G Use of neuraxial catheter for anaesthesia/analgesia in high-risk abdominal surgery patients: Lessons from the PEGASUS study [poster]. World Congress of Anaesthesiologists April 18-23, 2004, Paris, France.
Agnelli G, Bergqvist D, Cohen A, et al. Randomised double-blind study to compare the efficacy and safety of postoperative fondaparinux (Arixtra) and preoperative dalteparin in the prevention of venous thromboembolism after high-risk abdominal surgery: the PEGASUS Study [abstract]. Blood 2003; 102:15a.
Agnelli G. Postoperative fondaparinux versus preoperative dalteparin for prevention of venous thromboembolism in high-risk abdominal surgery. British Journal of Surgery 2005; 92: 1212 – 1220.
Randomized clinical trial of postoperative fondaparinux versus perioperative dalteparin for prevention of venous thromboembolism in high-risk abdominal surgery. Agnelli, G., Bergqvist, D., Cohen, A. T., Gallus, A. S., and Gent, M. Br J Surg 2005; 92. 92(10. 10):1212-20, 1212-20.
Abstract: A randomized double-blind study to compare the efficacy and safety of fondaparinux with dalteparin in the prevention of venous thromboembolism after high-risk abdominal surgery: the pegasus study. Agnelli G., Bergqvistt D. Cohen A. Gallus A. Gent T M. 19th Congress of the International Society on Thrombosis and Haemostasis and 49th Annual Scientific and Standardisation Committee Meeting 7/12/2003 Birmingham; UK
Abstract: A randomized double-blind study to compare the efficacy and safety of postoperative fondaparinux (arixtra®) and preoperative dalteparin in the prevention of venous thromboembolism after high-risk abdominal surgery: the pegasus study. Agnelli, Giancarlo, Bergqvist, David, Cohen, Alexander, Gallus, Alexander S., and Gent, Michael 45th Annual Meeting and Exposition of the American Society of Hematology 12/5/2003 San Diego, CA; USA
Agnelli G Use of neuraxial catheter for anaesthesia/analgesia in high-risk abdominal surgery patients: Lessons from the PEGASUS study [poster]. World Congress of Anaesthesiologists April 18-23, 2004, Paris, France.
Agnelli G, Bergqvist D, Cohen A, et al. Randomised double-blind study to compare the efficacy and safety of postoperative fondaparinux (Arixtra) and preoperative dalteparin in the prevention of venous thromboembolism after high-risk abdominal surgery: the PEGASUS Study [abstract]. Blood 2003; 102:15a.
Agnelli G. Postoperative fondaparinux versus preoperative dalteparin for prevention of venous thromboembolism in high-risk abdominal surgery. British Journal of Surgery 2005; 92: 1212 – 1220.
Randomized clinical trial of postoperative fondaparinux versus perioperative dalteparin for prevention of venous thromboembolism in high-risk abdominal surgery. Agnelli, G., Bergqvist, D., Cohen, A. T., Gallus, A. S., and Gent, M. Br J Surg 2005; 92. 92(10. 10):1212-20, 1212-20.
Medical condition
Secondary prevention of Thromboembolic events
Product
fondaparinux sodium
Collaborators
Not applicable
Study date(s)
N/A to Invalid Date
Type
Interventional
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

Clinical study report
Available language(s): English
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Scientific result summary
Available language(s): English
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If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

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

Additional information
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