comparative study of alx-0081 versus gpiib/iiia inhibitor in high risk percutaneous coronary intervention (pci) patients

Conditions: Unstable Angina; Non ST Segment Elevation Myocardial Infarction (NSTEMI); Stable Angina (Associated With High Risk PCI)

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).


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 \ 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.