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Evaluation of M118 in Percutaneous Coronary Intervention (EMINENCE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Momenta Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00543400
First received: October 11, 2007
Last updated: April 30, 2013
Last verified: April 2013
History of Changes

October 11, 2007
April 30, 2013
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 ] [ Designated as safety issue: No ]
Not Provided
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, Multi-center, Open-label, Parallel Group Feasibility Study to Determine the Safety and Efficacy of the Rationally Engineered Heparin M118 vs. Unfractionated Heparin (UFH) in Subjects With Stable Coronary Artery Disease Undergoing Percutaneous Coronary Intervention (PCI) And A Pharmacokinetic, Pharmacodynamic and Heparin Antibody Substudy

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: Open Label
Primary Purpose: Prevention
  • Coronary Artery Disease (CAD)
  • Percutaneous Coronary Intervention (PCI)
  • Drug: M118
    75 IU/KG of M118, 100 IU/kg of M118 and 70 U/kg of unfractionated heparin given IV (in the vein) 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
    Please see other invention description
  • Active Comparator: 1
    Intervention: Drug: Unfractionated Heparin
  • Experimental: 2
    Intervention: Drug: M118
Rao SV, Melloni C, Myles-Dimauro S, Broderick S, Kosinski AS, Kleiman NS, Dzavík V, Tanguay JF, Chandna H, Gammon R, Rivera E, Alexander JH, Fier I, Roach J, Becker RC; EMINENCE Investigators. Evaluation of a new heparin agent in percutaneous coronary intervention: results of the phase 2 evaluation of M118 IN pErcutaNeous Coronary intErvention (EMINENCE) Trial. Circulation. 2010 Apr 20;121(15):1713-21. Epub 2010 Apr 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
503
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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00543400
MOM-M118-006, M118-006a Substudy
Yes
Momenta Pharmaceuticals, Inc.
Momenta Pharmaceuticals, Inc.
Not Provided
Principal Investigator: Sunil Rao, MD Duke Clinical Research Institute
Momenta Pharmaceuticals, Inc.
April 2013

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