Evaluation of M118 in Percutaneous Coronary Intervention (EMINENCE)

Inclusion criteria

• Age > 19 years
• Ability to give informed consent
• Documented stable CAD with a significant lesion in a native coronary artery amenable to PCI with one stent
• Planned single vessel intervention

Exclusion criteria

• Myocardial infarction or unstable angina within the prior 7 days
• Target lesion is a chronic total occlusion (present for longer than 3 months)
• Target lesion with angiographically visible thrombus or in-stent thrombosis
• Target lesion is in a bypass graft
• Planned use of a GP IIb/IIIa inhibitor or planned use of atherectomy including directional, rotational, or laser
• Known allergies or sensitivities to heparin, pork, or pork-containing products
• History of HIT
• Hemodynamic instability
• Stroke or Transient Ischemic Attack (TIA) in the prior 3 months
• Active bleeding or bleeding diathesis
• Trauma or major surgery in the preceding month or planned surgery or PCI within the 30 days after the index PCI
• Suspected aortic dissection
• Receiving oral anticoagulation therapy
• Receipt of LMWH or of UFH (except for that used during the diagnostic portion of the index procedure) within the prior 7 days
• ACT > 200 prior to study drug administration
• Severe, untreated hypertension at the time of the index PCI procedure (systolic blood pressure of > 180 mm Hg, diastolic blood pressure > 90 mm Hg)
• Hemoglobin level of less than 10.0 g/dl or a hematocrit below 30%
• Platelet count of less than 100,000 per cubic millimeter or more than 600,000 per cubic millimeter
• Creatinine clearance < 30 mL/min
• Any malignancy within the prior 5 years with the exception of non-melanoma skin cancers
• Prior enrollment in EMINENCE trial or currently receiving other experimental therapy
• Pregnant or lactating if subject is female

Substudy:

Inclusion:

• Ability to give informed consent
• Participation in the main study protocol

Exclusion:

-Inability to provide the blood specimens required by the substudy protocol