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

Ablynx, a Sanofi company0 sites364 target enrollmentSeptember 2009

ConditionsUnstable Angina Non ST Segment Elevation Myocardial Infarction (NSTEMI)Stable Angina (Associated With High Risk PCI)

InterventionsALX-0081 ReoPro®

DrugsALX-0081 ReoPro®

Overview

Phase: Phase 2
Intervention: ALX-0081
Conditions: Unstable Angina
Sponsor: Ablynx, a Sanofi company
Enrollment: 364
Primary Endpoint: 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
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

March 2012

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ablynx, a Sanofi company

Responsible Party

Sponsor

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/mm
•Body mass index (BMI) ≥18 kg/m2 and ≤ 35 kg/m
•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.

Arms & Interventions

ALX-0081

Intervention: ALX-0081

GPIIb/IIIa inhibitor

Intervention: ReoPro®

Outcomes

Primary Outcomes

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

Time Frame: 30 days