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

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).


Eligibility Criteria:
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 gender and/or lesion/anatomy related: SYNTAX score \> 26, bifurcation lesions, multi-vessel disease, intracoronary thrombus.
* Adequate hematological function including platelets \> 100000/mm3.
* Body mass index (BMI) ≥18 kg/m2 and ≤ 35 kg/m2.
* Aged ≥ 18 years old.
* Women of childbearing potential must be practicing a medically acceptable contraceptive regimen. Only males who do not want to father children during the study and in the first 4 months after treatment may be included in the study. During this period, safe contraception is mandatory. Male patients who are sexually active must use a condom during intercourse and ensure that the female partner uses a reliable contraceptive method, or they must refrain from sexual intercourse during the first 4 months after treatment.
* Patients must be accessible for follow-up.
* Have a sufficient command to read and understand all instructions necessary for giving informed consent and participating in the study.
* Have signed and dated written informed consent prior to any study-related procedures.

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.