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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01020383 | Comparative Study of ALX-0081 Versus GPIIb/IIIa Inhibitor in High Risk Percutaneous Coronary Intervention (PCI) Patients | PHASE2 | COMPLETED | 364 | — | — | Sep 1, 2009 | Mar 1, 2012 | Apr 4, 2023 | 39 | Austria, Belgium +5 |
| Arm | Type | Description |
|---|---|---|
| ALX-0081 | EXPERIMENTAL | - |
| GPIIb/IIIa inhibitor | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| ALX-0081 | DRUG | 4 i.v. bolus injections, once every 6 hours; first dose of 6 mg, three subsequent doses of 4 mg |
| ReoPro® | DRUG | 0.25 mg/kg i.v. bolus injection followed by continuous i.v. infusion of 0.125 µg/kg/min (to a max. of 10 µg/min) for 12 hours |
Inclusion Criteria: * Have unstable angina or NSTEMI,or stable angina with at least 2 factors indicating a high risk PCI as follows: patient related: diabetic patients, renal failure (glomerular filtration rate \< 60), reduced left ventricular ejection fraction \< 35%, age \> 75 years, female gende...