A phase II 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

• Conditions: Thrombotic events associated with percutaneous coronary intervention (PCI) in patients with unstable angina or Non ST-Segment Elevation Myocardial Infarction (NSTEMI), or stable angina with at least 2 factors indicating a high risk PCI.; MedDRA version: 9.1Level: LLTClassification code 10011099Term: Coronary disease; MedDRA version: 9.1Level: LLTClassification code 10011076Term: Coronary artery atherosclerosis; MedDRA version: 9.1Level: LLTClassification code 10011078Term: Coronary artery disease; MedDRA version: 9.1Level: LLTClassification code 10003211Term: Arteriosclerosis coronary artery; MedDRA version: 9.1Level: LLTClassification code 10013210Term: Disorder coronary artery; MedDRA version: 9.1Level: LLTClassification code 10063933Term: Coronary stent thrombosis; MedDRA version: 9.1Level: LLTClassification code 10065608Term: Percutaneous coronary intervention; MedDRA version: 9.1Level: LLTClassification code 10051592Term: Acute coronary syndrome; MedDRA version: 9.1Level: LLTClassification code 10011067Term: Coronary angiogram abnormal

• Registration Number: EUCTR2009-012206-39-AT
• Lead Sponsor: Ablynx

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-14
• Last Update Posted: 21 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 368

Inclusion Criteria

1.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.
2.Adequate hematological function including platelets > 100000/mm3.
3.Body mass index (BMI) =18 kg/m2 and = 35 kg/m2.
4.Aged = 18 years old.
5.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 entire clinical study. As reliable contraceptive methods for female partners the following measures are accepted:
•Hormonal contraception (e.g. pill, depot injection)
•Intrauterine device
•Diaphragm with spermicide
6.Patients must be accessible for follow-up.
7.Has a sufficient command to read and understand all instructions necessary for giving informed consent and participating in the study.
8.Has signed and dated written informed consent prior to any study-related procedures.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Previous (within 30 days) treatment with GPIIb/IIIa inhibitors (such as ReoPro®).
2.ST-elevation myocardial infarction (STEMI).
3.Chronic total occlusion of a coronary artery.
4.Scheduled rotablator procedure.
5.PCI of the arterial or venous by-pass graft.
6.Any contra-indication for ReoPro®.
7.Major organ dysfunction, infection or any serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
8.Known hypersensitivity to human/humanized antibodies.
9.Women who are pregnant or lactating.
10.Dementia or significantly altered mental status that would prohibit understanding the study procedures and giving informed consent.
11.Use of vitamin K antagonists and/or Factor Xa inhibitors within 4 weeks prior to admission to the Hospital Intensive Care Unit.
12.Use of GPIIa/IIIb inhibitors other then ReoPro®, prasugrel, bivalirudin and fondaparinux prior to and throughout the study.
13.Known history of acquired or congenital bleeding disorder, coagulopathy or platelet disorder.
14.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
15.History of intracranial bleeding e.g. hemorrhagic stroke, subdural hematoma, subarachnoid hemorrhage) or history of hemorrhagic retinopathy.
16. History of ischemic stroke or TIA, within the past year prior to screening or known structural cerebral vascular lesion (e.g. arteriovenous malformation, aneurysm).
17.History of New York Heart Association class III or IV congestive heart failure or history of severe, uncontrolled cardiac arrhythmias at screening.
18.Indication for further diagnostic testing prior to decision to perform PCI, 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).
19.Use of another investigational drug or device within previous 30 days (12 weeks for investigational devices, e.g. unapproved stents) prior to screening.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified