A Phase 2 Study of an Aptameric von Willebrand Factor Antagonist, ARC1779, in Patients with Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention

INTERVENTION: 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)/millilitre Concentration type: equal Concentration number: 1‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use 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)/millilitre Concentration type: equal Concentration number: 3‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use 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)/millilitre Concentration type: equal Concentration number: 10‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use Trade Name: ReoPro Product Name: abciximab Product Code: abciximab Pharmaceutical Form: Solution for injection INN or Proposed INN: abciximab Current Sponsor code: abciximab Other descriptive name: abciximab Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 2‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use CONDITION: 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 PRIMARY OUTCOME: 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; 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; 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; 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