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Evaluation of M118 in Percutaneous Coronary Intervention (EMINENCE) (EMINENCE)

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ClinicalTrials.gov Identifier: NCT00543400
Recruitment Status : Completed
First Posted : October 15, 2007
Results First Posted : December 12, 2017
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Momenta Pharmaceuticals, Inc.

October 11, 2007
October 15, 2007
October 25, 2013
December 12, 2017
January 25, 2018
September 2007
April 2009   (Final data collection date for primary outcome measure)
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. [ Time Frame: 30 days ]
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Complete list of historical versions of study NCT00543400 on ClinicalTrials.gov Archive Site
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Evaluation of M118 in Percutaneous Coronary Intervention (EMINENCE)
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)

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Coronary Artery Disease (CAD)
  • Drug: M118
    intravenous (IV) infusion
  • Drug: Unfractionated Heparin
    IV infusion
  • Active Comparator: 70 U/kg of unfractionated heparin given IV
    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.
    Intervention: Drug: Unfractionated Heparin
  • Experimental: 50 IU/KG of 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.
    Intervention: Drug: M118
  • Experimental: 75 IU/KG of 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.
    Intervention: Drug: M118
  • Experimental: 100 IU/KG of 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.
    Intervention: Drug: M118

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
503
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May 2009
April 2009   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
19 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00543400
MOM-M118-006
Yes
Not Provided
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Momenta Pharmaceuticals, Inc.
Momenta Pharmaceuticals, Inc.
Not Provided
Principal Investigator: Sunil Rao, MD Duke Clinical Research Institute
Momenta Pharmaceuticals, Inc.
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP