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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
-

Special Drug Use Investigation for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment

Completed
Conditions
Ataxia
Interventions
First Posted Date
2011-09-05
Last Posted Date
2015-07-15
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
200
Registration Number
NCT01428531

Special Drug Use Investigation (Retrospective) for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment (Over 100kg)

Completed
Conditions
Ataxia
Interventions
First Posted Date
2011-09-05
Last Posted Date
2015-07-15
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
5
Registration Number
NCT01428544

Fondaparinux EU-RMP (Adherence)

Completed
Conditions
Acute Coronary Syndrome
Interventions
First Posted Date
2011-08-01
Last Posted Date
2015-04-27
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
1
Registration Number
NCT01406301

Special Drug Use Investigation for ARIXTRA (Fondaparinux) Abdominal (Urology,Obstetrics,Gynecology)

Completed
Conditions
Cardiovascular Disease
Interventions
First Posted Date
2011-07-11
Last Posted Date
2015-03-27
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
475
Registration Number
NCT01390883

Special Drug Use Investigation for ARIXTRA (Fondaparinux) Abdominal General Surgery

Completed
Conditions
Cardiovascular Disease
Interventions
First Posted Date
2011-07-11
Last Posted Date
2014-07-28
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
329
Registration Number
NCT01390896

Retrospective Registry of Patients With Acute Heparin-induced Thrombocytopenia Type II

Completed
Conditions
Acute HIT II (Heparin-induced Thrombocytopenia Type II)
Interventions
First Posted Date
2011-02-25
Last Posted Date
2017-07-06
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
195
Registration Number
NCT01304238

The Impact of Different Anticoagulant Therapy on Hemorrhage and Coagulation After Thoracic Surgery

Not Applicable
Completed
Conditions
Lung Neoplasms
Esophageal Neoplasms
Venous Thromboembolism
Interventions
First Posted Date
2010-12-28
Last Posted Date
2014-04-29
Lead Sponsor
Shanghai Zhongshan Hospital
Target Recruit Count
362
Registration Number
NCT01267305
Locations
🇨🇳

Zhongshan Hospital, Shanghai, China

Hemorrhage Risk Prescribed Arixtra

Completed
Conditions
Thrombosis, Venous
Interventions
Drug: Fondaparinux sodium
Drug: Low molecular weight heparin (LMWH)
First Posted Date
2010-02-08
Last Posted Date
2015-05-12
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
13442
Registration Number
NCT01064362

Retrospective Study of Patients Who Were Treated With Fondaparinux Pre-, Peri- and/or Postpartum for Prophylaxis or Treatment of Venous Thromboembolism

Completed
Conditions
Thromboembolism
Venous Thromboembolism
Interventions
First Posted Date
2009-10-30
Last Posted Date
2011-08-26
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
120
Registration Number
NCT01004939
Locations
🇩🇪

GSK Investigational Site, Berlin, Germany

The Treatment of Acute Pulmonary Thromboembolism (PE) of GSK576428 (Fondaparinux Sodium) in Japanese Patients

Phase 3
Completed
Conditions
Embolism, Pulmonary
Interventions
First Posted Date
2009-09-22
Last Posted Date
2016-12-16
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
41
Registration Number
NCT00981409
Locations
🇯🇵

GSK Investigational Site, Tokyo, Japan

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