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 is used for the treatment of thromboembolism, specifically studied in patients with ST segment elevation acute myocardial infarction. It is a small molecule being developed by GSK plc for cardiovascular conditions. The drug is currently in Phase 3 clinical development and remains investigational.
Fondaparinux is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The drug is in Phase 3 clinical trials for the treatment of thromboembolism, a cardiovascular condition.
Fondaparinux is in Phase 3 clinical development. It has completed one Phase 3 trial, the OASIS-6 study, which enrolled 12,092 patients. The drug is investigational and has not been approved for use.
Fondaparinux has one completed Phase 3 clinical trial, identified as NCT00064428, titled 'OASIS-6: The Safety and Efficacy of Fondaparinux Versus Control Therapy in Patients With ST Segment Elevation Acute Myocardial Infarction.' This randomized, double-blind, placebo-controlled trial enrolled 12,092 patients with thromboembolism.
Fondaparinux is not the same as unfractionated heparin (UFH). The drug is a distinct small molecule developed for thromboembolism, and UFH is not indicated for use with fondaparinux. Fondaparinux is being studied as a separate therapeutic agent in Phase 3 clinical trials.