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Fondaparinux

Generic Name
Fondaparinux
Brand Names
Arixtra
Drug Type
Small Molecule
Chemical Formula
C31H53N3O49S8
CAS Number
104993-28-4
Unique Ingredient Identifier
J177FOW5JL
Background

Fondaparinux (Arixtra) is a synthetic anticoagulant agent consisting of five monomeric sugar units and a O-methyl group at the reducing end of the molecule. It is structurally similar to polymeric glycosaminoglycan heparin and heparan sulfate (HS) when they are cleaved into monomeric units. The monomeric sequence in heparin and HS is thought to form the high affinity binding site for the natural anti-coagulant factor, antithrombin III (ATIII). Once bound to heparin or HS, the anticoagulant activity of ATIII is potentiated by 1000-fold. Fondaparinux potentiates the neutralizing action of ATIII on activated Factor X 300-fold. Fondaparinux may be used: to prevent venous thromboembolism in patients who have undergone orthopedic surgery of the lower limbs (e.g. hip fracture, hip replacement and knee surgery); to prevent VTE in patients undergoing abdominal surgery who are are at high risk of thromboembolic complications; in the treatment of deep vein thrombosis (DVT) and pumonary embolism (PE); in the management of unstable angina (UA) and non-ST segment elevation myocardial infarction (NSTEMI); and in the management of ST segment elevation myocardial infarction (STEMI).

Indication

Approved for: (1) prophylaxis of VTE for up to one month post surgery in patients undergoing orthopedic surgery of the lower limbs such as hip fracture, hip replacement and knee surgery; (2) prophylaxis of VTE patients undergoing abdominal surgery who are at high risk of thromboembolic complications (e.g. patients undergoing abdominal cancer surgery); (3) treatment of acute DVT and PE; (4) management of UA and NSTEMI for the prevention of death and subsequent myocardial infarction (MI); and (5) management of STEMI for the prevention of death and myocardial reinfarction in patients who are managed with thrombolytics or who are initially to receive no form of reperfusion therapy. Fondaparinux should not be used as the sole anticoagulant during percutaneous coronary intervention (PCI) due to an increased risk of guiding catheter thrombosis.

Associated Conditions
Acute Pulmonary Embolism (PE), Deep Vein Thrombosis, Non ST Segment Elevation Myocardial Infarction (NSTEMI), ST Segment Elevation Myocardial Infarction (STEMI), Unstable Angina Pectoris, Acute, superficial, symptomatic Vein Thrombosis
Associated Therapies
-

Fondaparinux 1,5 mg for the Prevention of Venous Thromboembolism (VTE) in Medical Patients With Renal Insufficiency

Phase 4
Terminated
Conditions
Medical Patients
Renal Insufficiency
Interventions
First Posted Date
2009-06-25
Last Posted Date
2012-04-24
Lead Sponsor
Università degli Studi dell'Insubria
Target Recruit Count
206
Registration Number
NCT00927602
Locations
🇮🇹

University Of Insubria, Varese, Italy

Evaluation of Fondaparinux in Patients With a Heart Rhythm Disturbance Who Undergo Restoration of Normal Heart Rhythm

Phase 2
Completed
Conditions
Fibrillation, Atrial
Interventions
First Posted Date
2009-06-01
Last Posted Date
2012-10-01
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
349
Registration Number
NCT00911300
Locations
🇩🇪

GSK Investigational Site, Berlin, Germany

The Treatment of Acute Deep Vein Thrombosis (DVT) of GSK576428 (Fondaparinux Sodium) in Japanese Patients

Phase 3
Completed
Conditions
Thrombosis, Venous
Interventions
First Posted Date
2009-06-01
Last Posted Date
2016-11-23
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
39
Registration Number
NCT00911157
Locations
🇯🇵

GSK Investigational Site, Tokyo, Japan

Comparing Enoxaparin to Fondaparinux to Prevent Venous Thromboembolism (VTE) in Bariatric Surgical Patients

Early Phase 1
Completed
Conditions
Deep Venous Thrombosis
Pulmonary Embolism
Interventions
First Posted Date
2009-05-06
Last Posted Date
2019-06-07
Lead Sponsor
Johns Hopkins University
Target Recruit Count
198
Registration Number
NCT00894283
Locations
🇺🇸

Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States

Prophylaxis of Thromboembolic Complications Trial: Thromboprophylaxis Needed in Below Knee Plaster Cast Immobilization for Ankle and Foot Fractures

Phase 2
Conditions
Deep Vein Thrombosis
Pulmonary Embolism
Interventions
First Posted Date
2009-04-15
Last Posted Date
2012-12-18
Lead Sponsor
Red Cross Hospital Beverwijk
Target Recruit Count
669
Registration Number
NCT00881088
Locations
🇳🇱

Medical Center Alkmaar, Alkmaar, North Holland, Netherlands

🇳🇱

University Medical Center Nijmegen, Nijmegen, Gelderland, Netherlands

🇳🇱

Red Cross Hospital, Beverwijk, N-Holland, Netherlands

and more 2 locations

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

Phase 3
Completed
Conditions
Thrombosis, Venous
Interventions
First Posted Date
2009-02-13
Last Posted Date
2016-03-16
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
1351
Registration Number
NCT00843492
Locations
🇪🇸

GSK Investigational Site, Vigo/Pontevedra, Spain

A Study of the Efficacy of Preventive Dosing of Fondaparinux Sodium Versus Placebo for the Prevention of Venous Thromboembolism (VTE) in Patients Undergoing Coronary Bypass Surgery Receiving Routine Mechanical Prophylaxis

Not Applicable
Terminated
Conditions
Deep Vein Thrombosis
Coronary Artery Bypass Surgery
Venous Thromboembolism
Interventions
Other: Placebo
Drug: Fondaparinux
First Posted Date
2008-11-11
Last Posted Date
2022-09-08
Lead Sponsor
Prairie Education and Research Cooperative
Target Recruit Count
78
Registration Number
NCT00789399

Fondaparinux for the Treatment of Heparin-Induced Thrombocytopenia (HIT)

Phase 2
Terminated
Conditions
Heparin-Induced Thrombocytopenia
Interventions
First Posted Date
2008-05-07
Last Posted Date
2019-11-08
Lead Sponsor
University of Louisville
Target Recruit Count
3
Registration Number
NCT00673439
Locations
🇺🇸

University of Louisville Hospital, Louisville, Kentucky, United States

Feasibility Study of Short Term Fondaparinux (Arixtra) in Chemotherapy-Pretreated Ovarian Carcinoma Patients at High Risk of Progression

Phase 1
Withdrawn
Conditions
Ovarian Carcinoma
First Posted Date
2008-04-16
Last Posted Date
2015-03-18
Lead Sponsor
NYU Langone Health
Registration Number
NCT00659399
Locations
🇺🇸

NYU Cancer Institute Clinical Cancer Center, New York, New York, United States

Fondaparinux in Patients With Acute Heparin-Induced Thrombocytopenia (HIT)

Phase 4
Withdrawn
Conditions
Heparin-Induced Thrombocytopenia
Interventions
First Posted Date
2008-01-29
Last Posted Date
2019-08-13
Lead Sponsor
Methodist Healthcare
Registration Number
NCT00603824
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