Evaluation of M118 in Percutaneous Coronary Intervention (EMINENCE) (EMINENCE)
Coronary Artery Disease (CAD)
About this trial
This is an interventional prevention trial for Coronary Artery Disease (CAD) focused on measuring Percutaneous Coronary Intervention (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
Sites / Locations
- Central Arkansas Veterans Healthcare System
- Washington Hospital Center, Medstar Research Institute
- Jim Moran Heart & Vascular Research Institute
- Shands Jacksonville Medical Center (UFL)
- Cardiology Research Associates
- Suncoast Cardiovascular Research
- Emory University Hospital
- Advocate Good Shephard Hospital
- Rush University Medical Center
- University of Chicago
- Trinity Medical Center
- Midwest Cardiovascular Research Foundation
- University of Kentucky-Gill Heart Institute
- Beth Israel Deaconess Medical Center
- University of Michigan Health System
- Henry Ford Hospital Heart & Vascular Institute
- Genesys Regional Medical Center
- Saint Mary's Duluth Clinic Health Center
- Minneapolis VA Medical Center
- Saint-Luke's Hospital / Mid America Heart Institute
- Saint Louis University Hospital
- UNC Health Systems
- Wake Forest University Health Sciences
- Riverside Methodist Hospital
- Genesis Health Care System
- Allegheny Hospital
- Black Hills Clinical Research Center
- Centennial Heart Cardiovascular Consultants
- Northwest Texas Healthcare System_Amarillo Heart Clinical Research Institute, Inc.
- Austin Heart, P.A.
- Plaza Medical Center of Fort Worth
- The Methodist Hospital
- Victoria Heart & Vascular Center
- Providence Health Center
- UVA Cardiology, UVA Health System
- McGuire VA Medical Center
- Comprehensive Cardiology Care
- University of Alberta Hospital, WMC
- Vancouver General Hospital: Interventional Research
- University of Ottawa Heart Institute
- Sunnybrook Health Sciences Center
- Toronto General Hospital
- St. Michael's Hospital
- Montreal Heart Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Experimental
Experimental
Experimental
70 U/kg of unfractionated heparin given IV
50 IU/KG of M118
75 IU/KG of M118
100 IU/KG of M118
Venous injection (IV) of 70 units per kilogram (U/kg) of unfractionated heparin prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
Venous injection of 50 international units per kilogram (IU/kg) of M118 prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
Venous injection of 75 IU/kg of M118 prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
Venous injection of 100 IU/kg of M118 prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.