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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00543400
First Posted: October 15, 2007
Last Update Posted: November 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Momenta Pharmaceuticals, Inc.
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease (CAD) Percutaneous Coronary Intervention (PCI) Drug: M118 Drug: Unfractionated Heparin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Momenta Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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 ]

Enrollment: 503
Study Start Date: September 2007
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Unfractionated Heparin
Please see other invention description
Experimental: 2 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00543400


  Show 44 Study Locations
Sponsors and Collaborators
Momenta Pharmaceuticals, Inc.
Investigators
Principal Investigator: Sunil Rao, MD Duke Clinical Research Institute
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Momenta Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00543400     History of Changes
Other Study ID Numbers: MOM-M118-006
M118-006a Substudy
First Submitted: October 11, 2007
First Posted: October 15, 2007
Last Update Posted: November 14, 2017
Last Verified: April 2013

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Calcium heparin
Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action