Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Fondaparinux · 10 trials · 7 indications
VTE is defined as asymptomatic deep vein thrombosis (DVT: the formation of a blood clot in a deep vein) detected by systematic compression ultrasonography, symptomatic DVT, or symptomatic fatal or non-fatal pulmonary embolism (PE). An embolism is a clot in the blood that forms and blocks a blood vessel. A pulmonary embolism is a blood clot that has travelled from elsewhere in the body through the blood stream to block the main artery of the lung or one of its branches. All venous thromboembolic events and deaths were adjudicated by the independent Central Adjudication Committee (CAC).
VTE (pulmonary thromboembolism \[PE\] and/or deep vein thrombosis \[DVT\]) was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE).
VTE (pulmonary thromboembolism \[PE\] and/or deep vein thromboembolism \[DVT\]) was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE).
Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of venous thromboembolic events (VTE) included, but were not limited to lower extremity deep vein thrombosis (DVT): erythema, warmth, pain, swelling, tenderness and pulmonary embolism (PE): pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the Central Independent Adjudication Committee of Efficacy (CIACE).
The percentage of participants with VTE, who underwent elective total hip replacement surgery, detected by routine venography, during the treatment period were reported. The percentage VTE was calculated by the number of events divided by the number of participants evaluated multiplied by 100. The Venogram was obtained post 2 calendar days after the administration of last study drug (between Day 11 and 17). Day 1 was the day of surgery and the participant was given study drug 24±2 hours after surgical closure. It was adjudicated by the Central Independent Adjudication Committee of Efficacy (CIACE).
Major bleeding defined as any clinically unusual bleeding meeting 1 of following criteria; a)Fatal bleeding; b) Including retroperitoneal and intracranial bleeding, or bleeding into critical organ (eye, adrenal gland, pericardium, spine); c) Reoperation due to bleeding or hematoma at operative site; d)Bleeding leading to hemoglobin (Hb) fall \> = 2 gram per deciliter (g/dL)(1.6 millimole per litre \[mmol/L\]) within 48 hour of the bleed; e)Bleeding that required transfusion of red blood cells (RBCs) or whole blood (WB) derived from \>= 900 milliliter (mL) of WB within 48 hours of the bleed (excluding autologous transfusion except for treatment of bleeding adverse event); f) Bleeding leading to bleeding index (BI) \>=2. The percentage was calculated by the number of events divided by the number of participants evaluated multiplied by 100. This was adjudicated by the CIACE.
first occurrence of any component of death, myocardial infarction or
incidence of adjudicated major bleeding
the incidence of VTE determined as any of the following VTE outcomes recorded up to the first venogram performed or up to Day 10, whichever occurred first: adjudicated manadatory veongram positive for DVT between Day 5 and Day 10; adjudicated symptomatic DVT and/or adjudicated non-fatal PE; adjudicated fatal PE
Cerebral neurologic events are defined as any new neurologic disorders caused by cerebrovascular embolization, e.g., Transient Ischemic Attack (TIA), cerebral infarction. The cerebrovascular origin of the event has to be confirmed by objective procedures. Systemic thromboembolism comprises any arterial thromboembolic event (e.g., peripheral vascular embolism, mesenteric infarct, or myocardial infarction). All cerebral neurologic events were adjudicated by a Central Adjudication Committee (CAC), members of which were unaware of the participants' treatment assignment.
| Arm | Type | Description |
|---|---|---|
| Nadroparin | ACTIVE_COMPARATOR | After randomization (Day 1), subjects will receive subcutaneously once daily nadroparin 2850 anti-Xa IU (0.3 mL) for at least 21 Days, up to complete mobilization, corresponding to cast or brace removal. The maximal duration of treatment is 45 days. Patients will then be followed up to five weeks (± one week) after the cast or brace removal. |
| Fondaparinux | EXPERIMENTAL | After randomization (Day 1), subjects will receive subcutaneously, once daily, fondaparinux 2.5 mg (1.5 mg in patients with creatinine clearance between 30 and 50 mL/min) for at least 21 Days, up to complete mobilization, corresponding to cast or brace removal. The maximal duration of treatment is 45 days. Patients will then be followed up to five weeks (± one week) after the cast or brace removal. |
| unfractionated heparin | OTHER | - |
| Enoxaparin | ACTIVE_COMPARATOR | - |
| Placebo + intermittent pneumatic compression (IPC) | PLACEBO_COMPARATOR | - |
| fondaparinux + intermittent pneumatic compression (IPC) | EXPERIMENTAL | - |
| Arm 1: fondaparinux | ACTIVE_COMPARATOR | - |
| Arm 2: unfractionated heparin + Vitamin-K-Antagonist | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Fondaparinux sodium | DRUG | After randomization (Day 1), subjects will receive subcutaneously once daily fondaparinux 2.5 mg \[0.5mL\] (1.5 mg \[0.3mL\] in patients with creatinine clearance between 30 and 50 mL/min) for at least 21 Days, up to complete mobilization, corresponding to cast or brace removal. The maximal duration of treatment is 45 days. |
| Nadroparin | DRUG | After randomization (Day 1), subjects will receive subcutaneously once daily nadroparin 2850 anti-Xa IU (0.3 mL) for at least 21 Days, up to complete mobilization, corresponding to cast or brace removal. The maximal duration of treatment is 45 days. |
| unfractionated heparin (UFH) | DRUG | UFH therapy will be started on Day 1 while adjusting activated partial thromboplastin time (aPTT) to maintain aPTT 1.5 to 2.5 times control. |
| GSK576428 | DRUG | - |
| Fondaparinux | DRUG | - |
| enoxaparin | DRUG | enoxaparin 1mg/kg s.c. injection twice daily x 2 to 8 days |
| placebo | OTHER | placebo, daily, s.c. starting 6 to 8 hours after surgical closure for up to 7 +/- 2 days, administered on top of IPC +/- elastic stockings (ES) |
| unfractionated heparin | DRUG | Comparison of different drugs |
| Vitamin-K-Antagonist | DRUG | Comparison of different drugs |
Inclusion Criteria: * Requiring rigid or semi-rigid immobilization (e.g. with a plaster cast or brace) for at least 21 days and up to 45 days because of isolated non-surgical below-knee injury * With a no weight-bearing recommendation at the time of inclusion (partial weight bearing is permitted e....
Fondaparinux is an investigational small molecule being developed for cardiovascular conditions including thromboembolism, venous thromboembolism, atrial fibrillation, pulmonary embolism, deep venous thrombosis, and venous thrombosis. It is being studied for the prevention of venous thromboembolic events in patients undergoing major abdominal surgery and for other thromboembolic indications.
Fondaparinux is being developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical trials to evaluate the drug's efficacy and safety for various thromboembolic conditions.
Fondaparinux is in Phase 1 of clinical development. While earlier trials have been completed, the drug remains investigational and has not been approved by regulatory authorities. It is still undergoing clinical evaluation for its safety and efficacy.
Fondaparinux has been studied in several completed trials, including NCT00038961 (APOLLO), NCT00139815 (Michelangelo-Oasis 5), NCT00320424 (Hip Fracture Study), and NCT00911300 (a Phase 2 trial in atrial fibrillation). These trials have enrolled over 21,000 participants across various thromboembolic conditions.
Yes, Fondaparinux is also known as GSK576428. A completed clinical trial, NCT00320424, titled 'Hip Fracture Study of GSK576428 (Fondaparinux Sodium)', confirms that GSK576428 is an alternative name for Fondaparinux.
Fondaparinux is a small molecule anticoagulant that works by inhibiting factor Xa, a key enzyme in the blood coagulation cascade. By targeting factor Xa, it helps prevent the formation of blood clots, which is relevant for treating and preventing thromboembolic disorders.