Safety of PZ-128 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention

Inclusion Criteria

• The subject is at least 18 years of age and may be of either sex/gender and of any race and ethnicity.
• The subject is scheduled to undergo non-emergent PCI or non-emergent cardiac catheterization with the intention of performing PCI. The following classifications of the urgency of the procedure at the time the operator decides to perform it will be used for randomization stratification:
• Elective: The cardiac catheterization procedure ± PCI can be performed on an outpatient basis or during a subsequent hospitalization without significant risk of MI or death. For stable inpatients, this is a procedure that is performed during the hospitalization for convenience and ease of scheduling only and not because the subject's clinical situation demands that the procedure be performed prior to discharge.

OR

• Urgent: The cardiac catheterization ± PCI procedure should be performed on an inpatient basis and before discharge because of significant concerns about the risk of myocardial ischemia, MI and/or death. For subjects who are outpatients or in the emergency department at the time that the cardiac catheterization is requested, this is a procedure that would warrant hospital admission based on clinical presentation.
• There is no anticipation that the subject would require treatment with a GP IIb/IIIa inhibitor prior to the initiation of the cardiac catheterization ± PCI procedure if the subject were not a participant in the current research study, and no anticipation of use during the procedure.
• The subject is willing and able to give appropriate informed consent and complete all study-related procedures, and able to adhere to dosing and visit schedules (i.e., subject signs an approved informed consent document(s) and provides HIPAA authorization);
• The subject will undergo all of the pre-enrollment parameters according to the study protocol prior to randomization and have them completed within 14 days prior to the scheduled cardiac catheterization ± PCI procedure and study drug administration.
• Women of childbearing potential (all postmenarchal women who are 185 mm Hg or diastolic blood pressure >105 mm Hg with or without anti-hypertensive treatment (as demonstrated by repeated BP measurements >185/105 mm Hg including the final BP measurement before randomization).
• Hypotension: systolic blood pressure 175 kg.
• Current evidence of invasive cancer (persistent disease excluding basal cell carcinoma of the skin) or treatment for invasive cancer within the past 6 months prior to randomization.
• Left ventricular ejection fraction <25% if known (any imaging technique) or New York Heart Association (NYHA) Class IV congestive heart failure.

(Exclusionary Prior/Concomitant/Anticipated Medication/Therapy)

• Coronary interventional procedure of any kind within the past 30 days prior to randomization.
• Anticipated subsequent staged multi-vessel PCI within 30 days following the study drug administration.
• History of treatment with any parenteral GP IIb/IIIa inhibitor (GPI) within the past 30 days prior to randomization. (As stated in the Inclusion section, the planned treatment with a GPI prior to initiation of the cardiac catheterization ± PCI is not allowed; however, GPI for thrombotic bailout may be used during the PCI at the investigator's discretion).
• Concurrent or anticipated treatment with a parenteral direct thrombin inhibitor (e.g., bivalirudin) for the cardiac catheterization ± PCI procedure.
• History of treatment with another PAR1 inhibitor within the past 60 days prior to randomization or the concurrent/anticipated use after randomization up until 30 days following the study drug administration.
• History of treatment with another IV anti-platelet drug within 30 days prior to randomization or the concurrent/anticipated use after randomization up until 30 days following the study drug administration.
• Any of the following anticoagulant or thrombolytic/fibrinolytic trea