Evaluation of M118 in Percutaneous Coronary Intervention (EMINENCE)

• Register: ClinicalTrials.gov
• Last refreshed on: 6 May 2013
• Main ID: NCT00543400
• Date of registration: 11/10/2007
• Primary sponsor: Momenta Pharmaceuticals, Inc.
• Public title: Evaluation of M118 in Percutaneous Coronary Intervention (EMINENCE) EMINENCE
• Scientific 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
• Date of first enrolment: September 2007
• Target sample size: 503
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00543400
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Countries of recruitment

Canada, United States

Contacts

• Name: Sunil Rao, MD
• Affiliation: Duke Clinical Research Institute

Key inclusion & exclusion 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



Age minimum: 19 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Coronary Artery Disease (CAD)

Percutaneous Coronary Intervention (PCI)

Intervention(s)

Drug: M118

Drug: Unfractionated Heparin

Primary Outcome(s)

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]

Secondary ID(s)

M118-006a Substudy

MOM-M118-006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors