Evaluation of M118 in Percutaneous Coronary Intervention (EMINENCE)

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Open-label, Parallel Group Feasibility Study to Determine the Safety and Efficacy of M118 vs. Unfractionated Heparin (UFH) in Subjects With Stable Coronary Artery Disease Undergoing Percutaneous Coronary Intervention (PCI)

Conditions
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Coronary Artery Disease (CAD)

Intervention / Treatment
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* Drug: M118
* Drug: Unfractionated Heparin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 70 U/kg of unfractionated heparin given IV<br>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. | Drug: Unfractionated Heparin<br>* IV infusion<br>|
| Experimental: 50 IU/KG of M118<br>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. | Drug: M118<br>* intravenous (IV) infusion<br>|
| Experimental: 75 IU/KG of M118<br>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. | Drug: M118<br>* intravenous (IV) infusion<br>|
| Experimental: 100 IU/KG of M118<br>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. | Drug: M118<br>* intravenous (IV) infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous Coronary Intervention (PCI)