Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00064428 | OASIS-6 : The Safety and Efficacy of Fondaparinux Versus Control Therapy in Patients With ST Segment Elevation Acute Myocardial Infarction | PHASE3 | COMPLETED | 12,092 | — | — | Aug 1, 2003 | Feb 1, 2006 | Sep 23, 2016 | - | — |
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 ≥...