Trials / Completed
CompletedNCT01020383
Comparative Study of ALX-0081 Versus GPIIb/IIIa Inhibitor in High Risk Percutaneous Coronary Intervention (PCI) Patients
A Phase 2 Randomized, Open Label Clinical Trial in High Risk Percutaneous Coronary Intervention (PCI) Patients Receiving Standard Antithrombotic Treatment Plus Either ALX-0081 or GPIIb/IIIa Inhibitor (ReoPro®) Over a Period of 24 Hours
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 364 (actual)
- Sponsor
- Ablynx, a Sanofi company · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter, randomized and open-label Phase II study to compare the safety, tolerability and biological effectiveness of ALX-0081 versus the GPIIb/IIIa inhibitor ReoPro® in high risk PCI patients. Patients will receive standard treatment with acetylsalicylic acid (ASA) plus clopidogrel and heparin. Eligible patients will be randomly assigned to receive open-label study treatment with either ALX-0081 or ReoPro®. Patients will be stratified according to PCI type (elective or ad-hoc) and stent type (bare metal stent or drug eluting stent).
Conditions
- Unstable Angina
- Non ST Segment Elevation Myocardial Infarction (NSTEMI)
- Stable Angina (Associated With High Risk PCI)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ALX-0081 | 4 i.v. bolus injections, once every 6 hours; first dose of 6 mg, three subsequent doses of 4 mg |
| DRUG | ReoPro® | 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 |
Timeline
- Start date
- 2009-09-01
- Primary completion
- 2011-04-01
- Completion
- 2012-03-01
- First posted
- 2009-11-24
- Last updated
- 2023-04-04
Locations
39 sites across 7 countries: Austria, Belgium, Czechia, Germany, Israel, Poland, Switzerland
Source: ClinicalTrials.gov record NCT01020383. Inclusion in this directory is not an endorsement.