Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
fondaparinux- UFH not indicated · 1 trial · 1 indication
the first occurrence of any component of death (all-cause mortality) or recurrent myocardial infarction
Severe hemorrhage (modified TIMI criteria)
| Arm | Type | Description |
|---|---|---|
| Fondaparinux - UFH not indicated | EXPERIMENTAL | Subjects with no indication for UFH therapy: 2.5mg od, sc, (1st dose IV) x 8 days or discharge |
| Control - UFH not indicated | PLACEBO_COMPARATOR | Subjects with no indication for UFH therapy: Fondaparinux-placebo od, sc (1st dose IV) x 8 days or discharge |
| Fondaparinux - UFH indicated | EXPERIMENTAL | Subjects indicated for UFH: 2.5mg od, sc (1st dose IV) x 8 days or discharge + UFH-placebo IV bolus + 24-48 hr infusion |
| Control - unfractionated heparin | ACTIVE_COMPARATOR | Subjects indicated for UFH: UFH IV bolus +12 IU/kg/hr infusion x 24-48 hr + fondaparinux-placebo od, sc (1st dose IV) x 8 days or discharge |
| Name | Type | Description |
|---|---|---|
| fondaparinux - UFH not indicated | DRUG | 2.5mg od, sc (1st dose IV) x 8 days or discharge |
| Control - UFH not indicated | OTHER | Fondaparinux-placebo od, sc (1st dose IV) x 8 days or discharge |
| Fondaparinux - UFH indicated | DRUG | 2.5mg od, sc (1st dose IV) x 8 days or discharge + UFH-placebo IV bolus x 24-48 hr infusion |
| Control - UFH | DRUG | UFH IV bolus +12 IU/kg/hr infusion x 24-48 hr + fondaparinux-placebo od, sc (1st dose IV) x 8 days or discharge |
Inclusion Criteria: * Subjects who presented or were admitted to hospital with: 1. Signs and symptoms of AMI 2. Were able to randomize within 12 hours of symptom onset; and- 3. Had definite ECG changes indicating STEMI: persistent ST-elevation (≥0.2mV in two contiguous precordial leads, or ≥...
Fondaparinux - UFH not indicated is used in patients with ST segment elevation acute myocardial infarction, a condition that carries a risk of thromboembolism. It was studied as an antithrombotic treatment in that acute coronary setting. The OASIS-6 trial evaluated its safety and efficacy in this patient population.
Fondaparinux - UFH not indicated is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the clinical program for this asset in cardiovascular medicine.
Fondaparinux - UFH not indicated is in Phase 3 development. Its Phase 3 trial has completed, and no trials for this asset are currently active. It is an investigational therapy rather than a marketed product.
Fondaparinux - UFH not indicated was studied in the OASIS-6 trial, registered as NCT00064428. That Phase 3 study enrolled 12,092 patients aged 21 years and older with ST segment elevation acute myocardial infarction. It was randomized, double blind, and placebo controlled, and it has completed.
Fondaparinux - UFH not indicated is a small molecule antithrombotic agent. It was developed for use in thromboembolism associated with ST segment elevation acute myocardial infarction, where clot formation is the central concern. Its Phase 3 evaluation compared it against control therapy in that acute coronary syndrome population.
Fondaparinux - UFH not indicated is also known by that same name, fondaparinux - UFH not indicated. The label reflects its use in patients for whom unfractionated heparin is not indicated. It is a small molecule developed by GSK plc for thromboembolism in acute myocardial infarction.