ACS Patients with Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention (ST segemnt elevation MI and Non ST segemtn elevation MI) MedDRA version: 9.1 Level: LLT Classification code 10064345 Term: ST segment elevation myocardial infarction MedDRA version: 9.1 Level: LLT Classification code 10064347 Term: Non ST segment elevation myocardial infarction
Conditions
Interventions
Product Name: ARC1779 Injection
Product Code: ARC1779
Pharmaceutical Form: Solution for injection
Current Sponsor code: ARC1779
Other descriptive name: ARC1779
Concentration unit: mg/ml milligram(s)/m
Sponsors
Archemix Corp.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet the following requirements to be enrolled in the study: ? = 18 to = 75 years of age ? Panel A: troponin-positive NSTEMI, with diagnostic symptoms and/or ECG abnormalities present within the preceding 24 hours, and a planned “early invasive” management strategy ? Panel B: STEMI, with planned primary PCI ? Females must be of non-childbearing potential, either post-menopausal (defined as = 55 years of age AND amenorrheic for = 1 year) or must have undergone a documented hysterectomy ? Males must agree to use a medically acceptable contraceptive (abstinence or use of a condom with spermicide) for at least 30 days after participation ? Must have signed the informed consent form prior to performance of study-related procedures ? Panel A only: platelet count =100,000/mm3 on pre-randomization CBC 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
Exclusion criteria: Patients must be excluded from the study if they meet any of the following: ? History of bleeding diathesis or evidence of active abnormal bleeding within the previous 30 days ? Received treatment with fibrinolytic or GPIIb/IIIa antagonist drugs within the preceding 72 hours ? Received anticoagulant therapy with a low molecular weight heparin within the preceding 8 hours ? Severe hypertension (systolic blood pressure >200 mmHg or diastolic blood pressure >110 mmHg) not adequately controlled on antihypertensive therapy ? Major surgery or trauma within the preceding 6 weeks ? History of stroke within 30 days or any history of hemorrhagic stroke ? End-stage renal disease (ESRD) with dependency on renal dialysis ? Contraindications for ReoPro® use including known thrombocytopenia, intracranial neoplasm, arteriovenous malformation or aneurysm, vasculitis, use of IV dextran before PCI or intended use during PCI, hypertensive retinopathy, severe hepatic failure ? Known hypersensitivity to abciximab or any component of the ReoPro® product (or to murine monoclonal antibodies) ? Known hypersensitivity to aspirin, clopidogrel, or heparin ? Weight > 125 kg ? Females of childbearing potential
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ? To assess the ability of ARC1779 to alleviate ischemic phenomena related to microvascular coronary thrombosis and thromboembolism ? To assess the risk of hemorrhage attributable to ARC1779 ;Secondary Objective: ? To assess the dose-response of ARC1779 for efficacy- and safety-related effects ? To assess the therapeutic window of ARC1779 with respect to the balance of anti-thrombotic versus pro-hemorrhagic actions ? To compare ARC1779 to a GPIIb/IIIa antagonist [ReoPro® (abciximab)] with respect to therapeutic window ;Primary end point(s): Safety Parameters: For all patients, the safety of ARC1779 administration will be assessed through evaluation of the following: ? Adverse events ? Clinical bleeding events: “TIMI” major, “TIMI minor” or any other clinically significant bleeding event ? Clinical laboratory tests (serum chemistries, urinalysis) ? Coagulation tests (ACT, PT, aPTT) ? Hematological profile (blood group typing, complete blood cell count with WBC differential and platelet count) ? Vital signs ? ECG recordings for PR, QRS, and QT intervals and evidence of arrhythmias Primary Efficacy Variables: ? TMPG immediately post-PCI ? Duration of ischemia by continuous ECG recording using a Holter monitor from immediately pre-PCI up to 48 hours later | — |
Countries
Austria, Germany
Outcome results
None listed