Trial Outcomes & Findings for Evaluation of M118 in Percutaneous Coronary Intervention (EMINENCE) (NCT NCT00543400)
NCT ID: NCT00543400
Last Updated: 2019-10-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
503 participants
Primary outcome timeframe
30 days
Results posted on
2019-10-15
Participant Flow
503 patients undergoing elective percutaneous coronary intervention at 43 centers in the United States and Canada were randomized
Participant milestones
| Measure |
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
151
|
44
|
152
|
156
|
|
Overall Study
COMPLETED
|
146
|
43
|
148
|
151
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
4
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of M118 in Percutaneous Coronary Intervention (EMINENCE)
Baseline characteristics by cohort
| Measure |
70 U/kg of Unfractionated Heparin Given IV
n=151 Participants
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
n=44 Participants
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
n=152 Participants
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
n=156 Participants
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
n=503 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
63.8 years
n=5 Participants
|
62.9 years
n=7 Participants
|
65.3 years
n=5 Participants
|
63.0 years
n=4 Participants
|
63.9 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
139 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
116 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
109 Participants
n=4 Participants
|
364 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
70 U/kg of Unfractionated Heparin Given IV
n=151 Participants
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
n=44 Participants
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
n=152 Participants
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
n=156 Participants
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.
|
|---|---|---|---|---|
|
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.
|
47 patients experiencing an event
|
10 patients experiencing an event
|
43 patients experiencing an event
|
47 patients experiencing an event
|
Adverse Events
70 U/kg of Unfractionated Heparin Given IV
Serious events: 20 serious events
Other events: 116 other events
Deaths: 0 deaths
50 IU/kg of M118
Serious events: 5 serious events
Other events: 36 other events
Deaths: 0 deaths
75 IU/KG of M118
Serious events: 15 serious events
Other events: 116 other events
Deaths: 0 deaths
100 IU/kg of M118
Serious events: 15 serious events
Other events: 114 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
70 U/kg of Unfractionated Heparin Given IV
n=151 participants at risk
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.
|
50 IU/kg of M118
n=44 participants at risk
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
n=152 participants at risk
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
n=156 participants at risk
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.
|
|---|---|---|---|---|
|
General disorders
All Serious Adverse Events
|
13.2%
20/151
|
11.4%
5/44
|
9.9%
15/152
|
9.6%
15/156
|
Other adverse events
| Measure |
70 U/kg of Unfractionated Heparin Given IV
n=151 participants at risk
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.
|
50 IU/kg of M118
n=44 participants at risk
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
n=152 participants at risk
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
n=156 participants at risk
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.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Catheter site hematoma
|
13.2%
20/151
|
4.5%
2/44
|
14.5%
22/152
|
17.9%
28/156
|
|
Injury, poisoning and procedural complications
Catheter site pain
|
7.3%
11/151
|
4.5%
2/44
|
7.9%
12/152
|
10.9%
17/156
|
|
Injury, poisoning and procedural complications
Catheter site hemorrhage
|
5.3%
8/151
|
4.5%
2/44
|
3.9%
6/152
|
7.1%
11/156
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.3%
17/151
|
25.0%
11/44
|
11.2%
17/152
|
11.5%
18/156
|
|
General disorders
Noncardiac chest pain
|
6.6%
10/151
|
9.1%
4/44
|
4.6%
7/152
|
9.0%
14/156
|
|
Gastrointestinal disorders
Nausea
|
8.6%
13/151
|
6.8%
3/44
|
6.6%
10/152
|
10.3%
16/156
|
|
Cardiac disorders
Angina pectoris
|
9.3%
14/151
|
11.4%
5/44
|
7.9%
12/152
|
6.4%
10/156
|
|
Nervous system disorders
Headache
|
10.6%
16/151
|
2.3%
1/44
|
7.2%
11/152
|
8.3%
13/156
|
|
Nervous system disorders
Dizziness
|
4.0%
6/151
|
9.1%
4/44
|
5.9%
9/152
|
4.5%
7/156
|
|
Vascular disorders
Hypotension
|
6.0%
9/151
|
4.5%
2/44
|
7.2%
11/152
|
3.8%
6/156
|
Additional Information
Jim Roach, MD Chief Medical Officer
Momenta Pharmaceuticals
Phone: 617-491-9700
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place