Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 33 of 172 for:    "Heart Disease" | "Heparin"

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 : October 15, 2019
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
Enrollment 503
Recruitment Details 503 patients undergoing elective percutaneous coronary intervention at 43 centers in the United States and Canada were randomized
Pre-assignment Details  
Arm/Group Title 70 U/kg of Unfractionated Heparin Given IV 50 IU/kg of M118 75 IU/KG of M118 100 IU/kg of M118
Hide Arm/Group Description 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. 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. 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. 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.
Period Title: Overall Study
Started 151 44 152 156
Completed 146 43 148 151
Not Completed 5 1 4 5
Arm/Group Title 70 U/kg of Unfractionated Heparin Given IV 50 IU/KG of M118 75 IU/KG of M118 100 IU/KG of M118 Total
Hide Arm/Group Description 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. 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 151 44 152 156 503
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 151 participants 44 participants 152 participants 156 participants 503 participants
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]
Measure Description: Overall age of participants
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants 44 participants 152 participants 156 participants 503 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%
1.Primary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 70 U/kg of Unfractionated Heparin Given IV 50 IU/kg of M118 75 IU/KG of M118 100 IU/kg of M118
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 151 44 152 156
Measure Type: Number
Unit of Measure: patients experiencing an event
47 10 43 47
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 70 U/kg of Unfractionated Heparin Given IV 50 IU/kg of M118 75 IU/KG of M118 100 IU/kg of M118
Hide Arm/Group Description Venous injection 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. 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. 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. 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.
All-Cause Mortality
70 U/kg of Unfractionated Heparin Given IV 50 IU/kg of M118 75 IU/KG of M118 100 IU/kg of M118
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
70 U/kg of Unfractionated Heparin Given IV 50 IU/kg of M118 75 IU/KG of M118 100 IU/kg of M118
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   20/151 (13.25%)   5/44 (11.36%)   15/152 (9.87%)   15/156 (9.62%) 
General disorders         
All Serious Adverse Events  20/151 (13.25%)  5/44 (11.36%)  15/152 (9.87%)  15/156 (9.62%) 
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
70 U/kg of Unfractionated Heparin Given IV 50 IU/kg of M118 75 IU/KG of M118 100 IU/kg of M118
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   116/151 (76.82%)   36/44 (81.82%)   116/152 (76.32%)   114/156 (73.08%) 
Cardiac disorders         
Angina pectoris  14/151 (9.27%)  5/44 (11.36%)  12/152 (7.89%)  10/156 (6.41%) 
Gastrointestinal disorders         
Nausea  13/151 (8.61%)  3/44 (6.82%)  10/152 (6.58%)  16/156 (10.26%) 
General disorders         
Noncardiac chest pain  10/151 (6.62%)  4/44 (9.09%)  7/152 (4.61%)  14/156 (8.97%) 
Injury, poisoning and procedural complications         
Catheter site hematoma  20/151 (13.25%)  2/44 (4.55%)  22/152 (14.47%)  28/156 (17.95%) 
Catheter site pain  11/151 (7.28%)  2/44 (4.55%)  12/152 (7.89%)  17/156 (10.90%) 
Catheter site hemorrhage  8/151 (5.30%)  2/44 (4.55%)  6/152 (3.95%)  11/156 (7.05%) 
Musculoskeletal and connective tissue disorders         
Back pain  17/151 (11.26%)  11/44 (25.00%)  17/152 (11.18%)  18/156 (11.54%) 
Nervous system disorders         
Headache  16/151 (10.60%)  1/44 (2.27%)  11/152 (7.24%)  13/156 (8.33%) 
Dizziness  6/151 (3.97%)  4/44 (9.09%)  9/152 (5.92%)  7/156 (4.49%) 
Vascular disorders         
Hypotension  9/151 (5.96%)  2/44 (4.55%)  11/152 (7.24%)  6/156 (3.85%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jim Roach, MD Chief Medical Officer
Organization: Momenta Pharmaceuticals
Phone: 617-491-9700
EMail: jroach@momentpharma.com
Layout table for additonal information
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: October 15, 2019