Clinical trial NCT01020383: Comparative Study of ALX-0081 Versus GPIIb/IIIa Inhibitor in High Risk Percutaneous Coronary Intervention (PCI) Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Unstable Angina
Non ST Segment Elevation Myocardial Infarction (NSTEMI)
Stable Angina (Associated With High Risk PCI)
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-11-24
Enrollment: 364
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 \< 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.

Primary outcomes:
measure: Incidence and severity of bleeding classified by the following criteria: TIMI major bleeding events, TIMI minor bleeding events, bleeding events requiring medical attention, defined as TIMI minimal bleeding events
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
city: Linz
country: Austria
city: Vienna
country: Austria
city: Aalst
country: Belgium
city: Charleroi
country: Belgium
city: Genk
country: Belgium
city: Jette
country: Belgium
city: Liège
country: Belgium
city: Yvoir
country: Belgium
city: Brno
country: Czechia
city: Prague
country: Czechia
city: Usti nad Labem
country: Czechia
city: Bad Nauheim
country: Germany
city: Coburg
country: Germany
city: Dortmund
country: Germany
city: Hamburg
country: Germany
city: Limburg
country: Germany
city: Oldenburg
country: Germany
city: Rostock
country: Germany
city: Ashkelion
country: Israel
city: Heifa
country: Israel
city: Jerusalem
country: Israel
city: Rehovot
country: Israel
city: Tel Hashomer
country: Israel
city: Bielsko-Biała
country: Poland
city: Dąbrowa Górnicza
country: Poland
city: Gdynia
country: Poland
city: Grodzisk Mazowiecki
country: Poland
city: Katowice
country: Poland
city: Kedzierzyn
country: Poland
city: Koscierzyna
country: Poland
city: Krakow
country: Poland
city: Lódz
country: Poland
city: Poznan
country: Poland
city: Torun
country: Poland
city: Warsaw
country: Poland
city: Wroclaw
country: Poland
city: Lausanne
country: Switzerland
city: Lugano
country: Switzerland
Study officials:
affiliation: Ablynx NV
name: Josefin-Beate Holz, MD
role: STUDY_DIRECTOR
References: