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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01076764 | Effect of Otamixaban Versus Unfractionated Heparin + Eptifibatide in Patients With Unstable Angina/Non ST Elevation Myocardial Infarction Undergoing Early Invasive Strategy | PHASE3 | COMPLETED | 13,220 | — | — | Apr 1, 2010 | May 1, 2013 | May 4, 2016 | 607 | United States, Argentina +53 |
| Arm | Type | Description |
|---|---|---|
| Otamixaban - 0.080 mg/kg bolus + 0.100 mg/kg/h infusion | EXPERIMENTAL | From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first: * Drug A: Otamixaban (0.080 mg/kg bolus followed by 0.100 mg/kg/h infusion) * Drug B: Placebo (for UFH) From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first: * Drug C: Placebo (for Eptifibatide) |
| Otamixaban - 0.080 mg/kg bolus + 0.140 mg/kg/h infusion | EXPERIMENTAL | From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first: * Drug A: Otamixaban 0.080 mg/kg bolus followed by 0.140 mg/kg/h infusion) * Drug B: Placebo (for UFH) From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first: * Drug C: Placebo (for Eptifibatide) |
| UFH + Eptifibatide | ACTIVE_COMPARATOR | From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first: * Drug A: Placebo (for Otamixaban) * Drug B: UFH (60 IU/kg bolus followed by 12 IU/kg/h infusion) From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first: * Drug C: Eptifibatide (180 mcg/kg bolus followed by 2 mcg/kg/min infusion) |
| Name | Type | Description |
|---|---|---|
| Otamixaban | DRUG | Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion |
| Placebo (for Otamixaban) | DRUG | Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion |
| UFH | DRUG | Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion |
| Placebo (for UFH) | DRUG | Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion |
| Eptifibatide | DRUG | Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion |
| Placebo (for Eptifibatide) | DRUG | Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion |
Inclusion criteria: Patient with non-ST-segment elevation Acute Coronary Syndrome (NSTE-ACS) with: 1. Ischemic symptoms (chest pain or equivalent) at rest ≥ 10 minutes within 24 hours of randomization, AND 2. One of the two following criteria: * New ST-segment depression ≥ 0.1 mV (≥1 mm), ...