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

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.
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.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Coronary Artery Disease (CAD)
Interventions: Drug: M118
Drug: Unfractionated Heparin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
503 patients undergoing elective percutaneous coronary intervention at 43 centers in the United States and Canada were randomized

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.
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.
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.
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.

Participant Flow:   Overall Study
    70 U/kg of Unfractionated Heparin Given IV   50 IU/kg of M118   75 IU/KG of M118   100 IU/kg of M118
STARTED   151   44   152   156 
COMPLETED   146   43   148   151 
NOT COMPLETED   5   1   4   5 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
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.
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.
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.
Total Total of all reporting groups

Baseline Measures
   70 U/kg of Unfractionated Heparin Given IV   50 IU/KG of M118   75 IU/KG of M118   100 IU/KG of M118   Total 
Overall Participants Analyzed 
[Units: Participants]
 151   44   152   156   503 
Age [1] 
[Units: Years]
Mean (Full Range)
 63.8 
 (56.8 to 71.6) 
 62.9 
 (54.1 to 70.9) 
 65.3 
 (57.4 to 71.0) 
 63.0 
 (58.3 to 69.9) 
 63.9 
 (54.1 to 71.6) 
[1] Overall age of participants
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      35  23.2%      13  29.5%      44  28.9%      47  30.1%      139  27.6% 
Male      116  76.8%      31  70.5%      108  71.1%      109  69.9%      364  72.4% 


  Outcome Measures

1.  Primary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jim Roach, MD Chief Medical Officer
Organization: Momenta Pharmaceuticals
phone: 617-491-9700
e-mail: jroach@momentpharma.com


Publications of Results:
Other Publications:

Responsible Party: Momenta Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00543400     History of Changes
Other Study ID Numbers: MOM-M118-006
First Submitted: October 11, 2007
First Posted: October 15, 2007
Results First Submitted: October 25, 2013
Results First Posted: December 12, 2017
Last Update Posted: January 25, 2018