EUCTR2009-012206-39-AT
Active, not recruiting
Not Applicable
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
DrugsReoPro
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Ablynx
- Enrollment
- 368
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
- •\-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
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.
Outcomes
Primary Outcomes
Not specified
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