Evaluation of M118 in Percutaneous Coronary Intervention (EMINENCE)
Condition: Coronary Artery Disease (CAD)
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: M118; Unfractionated Heparin
Intervention description: intravenous (IV) infusion; IV infusion
Intervention MeSH terms: Heparin; Calcium heparin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 503.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No
Keywords: Percutaneous Coronary Intervention (PCI)

Summary:

      The primary objective is to evaluate the safety and feasibility of using M118 as an
      anticoagulant in the target population of subjects with stable coronary artery disease (CAD)
      undergoing percutaneous coronary intervention (PCI).

      The secondary objectives are to evaluate the effect of M118 on procedural indices including
      procedure success, abrupt closure, post-procedure TIMI flow, and catheter thrombus.

      Substudy Primary Objective The primary objective of the substudy is to characterize the
      pharmacokinetic and pharmacodynamic profile of M118 among subjects with stable coronary
      artery disease undergoing elective PCI.
    

Eligibility criteria:

        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