Comparative Study of ALX-0081 Versus GPIIb/IIIa Inhibitor in High Risk Percutaneous Coronary Intervention (PCI) Patients

Exclusion Criteria

• •Previous (within 30 days) treatment with GPIIb/IIIa inhibitors (such as ReoPro®).
• •ST-elevation myocardial infarction (STEMI).
• •Chronic total occlusion of a coronary artery.
• •Scheduled rotablator procedure.
• •PCI of the arterial or venous by-pass graft.
• •Any contra-indication for ReoPro®.
• •Major organ dysfunction, infection or any serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
• •Known hypersensitivity to human/humanized antibodies.
• •Women who are pregnant or lactating.
• •Dementia or significantly altered mental status that would prohibit understanding the study procedures and giving informed consent.
• •Use of vitamin K antagonists and/or Factor Xa inhibitors within 4 weeks prior to admission to the Hospital Intensive Care Unit.
• •Use of GPIIa/IIIb inhibitors other than ReoPro®; prasugrel, bivalirudin and fondaparinux prior to and throughout the study.
• •Known history of acquired or congenital bleeding disorder, coagulopathy or platelet disorder.
• •Evidence of active pathological bleeding at screening or history of clinically significant bleeding (such as gastrointestinal or genitourinary) within the last 6 months prior to screening visit, unless the cause has been definitely corrected
• •History of intracranial bleeding (e.g. hemorrhagic stroke, subdural hematoma, subarachnoid hemorrhage) or history of hemorrhagic retinopathy.
• •History of ischemic stroke or TIA, within the past year prior to screening or known structural cerebral vascular lesion (e.g. arteriovenous malformation, aneurysm).
• •History of New York Heart Association class III or IV congestive heart failure or history of severe, uncontrolled cardiac arrhythmias at screening.
• •Planned elective surgical operation or major invasive procedures or traumas from 30 days prior to screening to completion of the study at Day 30 (the decision of what constitutes a major invasive procedure or trauma will be at the discretion of the investigator in conjunction with review and approval by the Medical Monitor).
• •Use of another investigational drug or device within previous 30 days (12 weeks for investigational devices, e.g. unapproved stents) prior to screening.