Evaluation of M118 in Percutaneous Coronary Intervention (EMINENCE)

Phase 2

Completed

Brief 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.

Recruitment & Eligibility

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:

Exclusion:

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

Arm && Interventions

Group	Intervention	Description
50 IU/KG of M118	M118	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.
100 IU/KG of M118	M118	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.
75 IU/KG of M118	M118	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.
70 U/kg of unfractionated heparin given IV	Unfractionated Heparin	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.

Primary Outcome Measures

Name	Time	Method
Clinical Events Defined as the Composite of 30-day Death, MI, Repeat Revascularization, Catheter Thrombus, Stroke, Thrombocytopenia, Bailout Use of Glycoprotein IIb/IIIa Inhibitors and Bleeding.	30 days

Secondary Outcome Measures

Name	Time	Method

Locations (44): Central Arkansas Veterans Healthcare System
🇺🇸
Little Rock, Arkansas, United States
Washington Hospital Center, Medstar Research Institute
🇺🇸
Washington, District of Columbia, United States
Jim Moran Heart & Vascular Research Institute
🇺🇸
Fort Lauderdale, Florida, United States
Shands Jacksonville Medical Center (UFL)
🇺🇸
Jacksonville, Florida, United States
Cardiology Research Associates
🇺🇸
Ormond Beach, Florida, United States
Suncoast Cardiovascular Research
🇺🇸
Saint Petersburg, Florida, United States
Emory University Hospital
🇺🇸
Atlanta, Georgia, United States
Advocate Good Shephard Hospital
🇺🇸
Barrington, Illinois, United States
Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
University of Chicago
🇺🇸
Chicago, Illinois, United States
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Central Arkansas Veterans Healthcare System
🇺🇸Little Rock, Arkansas, United States