Trial Outcomes & Findings for Efficacy Of Eptifibatide Compared To Abciximab In Primary Percutaneous Coronary Intervention (PCI) For Acute ST Elevation Myocardial Infarction (STEMI) (NCT NCT00426751)
NCT ID: NCT00426751
Last Updated: 2012-11-27
Results Overview
Sum STR was calculated as the difference between baseline (ECG I) and ECG III. The sum STR is the segment elevation resolution from all ECG leads associated with the infarct location. ST resolution, a method used to evaluate myocardial reperfusion, was expressed as a percentage of the baseline value (Complete: ≥ 70% resolution).
COMPLETED
PHASE3
429 participants
Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)
2012-11-27
Participant Flow
Participant milestones
| Measure |
Eptifibatide
Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
|
Abciximab
Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
|
|---|---|---|
|
Overall Study
STARTED
|
226
|
203
|
|
Overall Study
COMPLETED
|
204
|
183
|
|
Overall Study
NOT COMPLETED
|
22
|
20
|
Reasons for withdrawal
| Measure |
Eptifibatide
Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
|
Abciximab
Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
|
|---|---|---|
|
Overall Study
Adverse Event
|
8
|
1
|
|
Overall Study
Lost to Follow-up
|
7
|
6
|
|
Overall Study
Consent Withdrawn
|
0
|
1
|
|
Overall Study
Other Reasons
|
7
|
12
|
Baseline Characteristics
Efficacy Of Eptifibatide Compared To Abciximab In Primary Percutaneous Coronary Intervention (PCI) For Acute ST Elevation Myocardial Infarction (STEMI)
Baseline characteristics by cohort
| Measure |
Eptifibatide
n=214 Participants
Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
|
Abciximab
n=196 Participants
Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
|
Total
n=410 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
61.3 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
60.5 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
60.9 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
164 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
321 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)Population: Per Protocol (PP) Population: All randomized participants who received at least one dose of study drug, who had data that were fully evaluable for the primary endpoint, and who did not show any major protocol violation.
Sum STR was calculated as the difference between baseline (ECG I) and ECG III. The sum STR is the segment elevation resolution from all ECG leads associated with the infarct location. ST resolution, a method used to evaluate myocardial reperfusion, was expressed as a percentage of the baseline value (Complete: ≥ 70% resolution).
Outcome measures
| Measure |
Eptifibatide
n=113 Participants
Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
|
Abciximab
n=111 Participants
Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
|
|---|---|---|
|
Number of Participants With Complete Sum ST Resolution (STR) 60 Minutes (Min) After Percutaneous Coronary Intervention (PCI) (Per Protocol Population)
|
71 participants
|
65 participants
|
PRIMARY outcome
Timeframe: Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)Population: Intent-to-Treat (ITT) Population: All randomized participants who received at least one dose of study medication.
Sum STR was calculated as the difference between baseline (ECG I) and ECG III. The sum STR is the segment elevation resolution from all ECG leads associated with the infarct location. ST resolution, a method used to evaluate myocardial reperfusion, was expressed as a percentage of the baseline value (Complete: ≥ 70% resolution).
Outcome measures
| Measure |
Eptifibatide
n=214 Participants
Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
|
Abciximab
n=196 Participants
Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
|
|---|---|---|
|
Number of Participants With Complete Sum ST Resolution (STR) 60 Min After Percutaneous Coronary Intervention (PCI) (Intent-to-Treat Population)
|
124 participants
|
103 participants
|
SECONDARY outcome
Timeframe: Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)Population: ITT Population
Sum STR was calculated as the difference between baseline (ECGI) and ECG III. The sum STR is the segment elevation resolution from all ECG leads associated with infarct location. ST resolution, a method used to evaluate myocardial reperfusion, was expressed as a percentage of the baseline (Complete: ≥ 70% resolution; Partial: ≥ 30% and \< 70% resolution; None: \< 30% resolution).
Outcome measures
| Measure |
Eptifibatide
n=214 Participants
Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
|
Abciximab
n=196 Participants
Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
|
|---|---|---|
|
Number of Participants With Complete or Partial Sum ST Resolution (STR) 60 Min After PCI
Complete sum STR( ≥70%)
|
124 participants
|
103 participants
|
|
Number of Participants With Complete or Partial Sum ST Resolution (STR) 60 Min After PCI
Complete or partial sum STR (≥30%)
|
180 participants
|
154 participants
|
|
Number of Participants With Complete or Partial Sum ST Resolution (STR) 60 Min After PCI
Partial sum STR (≥30% and <70%)
|
56 participants
|
51 participants
|
|
Number of Participants With Complete or Partial Sum ST Resolution (STR) 60 Min After PCI
No sum STR (<30%)
|
34 participants
|
42 participants
|
SECONDARY outcome
Timeframe: Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)Population: ITT Population
Single lead STR is calculated as the difference (as a percentage) between baseline (ECG I) and ECG III of either the ST elevation on one of the leads (II, III, aVF, V5, and V6) or the ST depression of one of the precordial leads (V1- V4), whichever lead showed the largest deviation either at baseline or at ECG III, respectively (Complete: ≥ 70%; Partial: ≥ 30% and \<70%).
Outcome measures
| Measure |
Eptifibatide
n=214 Participants
Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
|
Abciximab
n=196 Participants
Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
|
|---|---|---|
|
Number of Participants With Complete Single Lead ST Resolution (STR) 60 Min After PCI
|
105 participants
|
82 participants
|
SECONDARY outcome
Timeframe: Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)Population: ITT Population. Some participants were un-evaluable with regard to the primary endpoint and were counted as failures. These participants were excluded from this analysis.
Sum STR was calculated as the difference between baseline (ECGI) and ECG III. The sum STR is the segment elevation resolution from all ECG leads associated with infarct location. ST resolution, a method used to evaluate myocardial reperfusion, was expressed as a percentage of the baseline.
Outcome measures
| Measure |
Eptifibatide
n=198 Participants
Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
|
Abciximab
n=183 Participants
Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
|
|---|---|---|
|
Mean Change From Baseline in the Sum ST Resolution 60 Min After PCI
|
71.6 percent change
Standard Deviation 27.2
|
66.3 percent change
Standard Deviation 31.1
|
SECONDARY outcome
Timeframe: Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)Population: ITT Population. Participants with unevaluable ECGs were excluded from analysis.
Single lead STR is calculated as the difference between baseline (ECG I) and ECG III of either the ST elevation on one of the leads (II, III, aVF, V5, and V6) or the ST depression of one of the precordial leads (V1 -V4), whichever lead showed the largest deviation either at baseline or at follow-up, respectively. STR was expressed as a percentage from baseline.
Outcome measures
| Measure |
Eptifibatide
n=176 Participants
Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
|
Abciximab
n=167 Participants
Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
|
|---|---|---|
|
Mean Change From Baseline in Single Lead ST Resolution (STR) 60 Min After PCI
|
70.2 percent change
Standard Deviation 25.5
|
64.0 percent change
Standard Deviation 28.7
|
SECONDARY outcome
Timeframe: Baseline (ECG I) and immediately prior to PCI (ECG II)Population: ITT Population. Participants who did not have an ECG II immediately before PCI were excluded from analysis.
Mean sum STR was calculated as the difference between baseline (ECGI) and ECG II: the mean of the sum of ST elevation resolution from all ECG leads associated with infarct location. ST resolution was expressed as a percentage from baseline.
Outcome measures
| Measure |
Eptifibatide
n=145 Participants
Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
|
Abciximab
n=120 Participants
Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
|
|---|---|---|
|
Mean Change From Baseline in the Sum ST Resolution (STR) Before PCI
|
25.9 percent change
Standard Deviation 32.0
|
21.2 percent change
Standard Deviation 29.0
|
SECONDARY outcome
Timeframe: 60 min +/- 15 min after PCI (ECG III)Population: ITT Population. Participants with unevaluable ECGs were excluded from analysis.
Max STE is measured similarly to single-lead STR, but was not compared with the ST deviation on the baseline ECG I. It was the existing ST deviation on the single ECG lead of maximum ST deviation present at 60 minutes after the PCI (ECG III).
Outcome measures
| Measure |
Eptifibatide
n=180 Participants
Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
|
Abciximab
n=172 Participants
Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
|
|---|---|---|
|
Mean Maximum ST Deviation Existing (Max STE) 60 Min After PCI
|
1.1 millimeters (mm)
Standard Deviation 1.1
|
1.4 millimeters (mm)
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: immediately before PCIPopulation: ITT Population
Number of participants with the respective patency of the infarcted vessels was evaluated by TIMI (Thrombolysis In Myocardial Infarction) flow grades (Grade 0 = No perfusion, Grade 1 = Penetration with minimal perfusion, Grade 2 = Partial perfusion, Grade 3 = Complete perfusion), as assessed by core angiography lab.
Outcome measures
| Measure |
Eptifibatide
n=214 Participants
Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
|
Abciximab
n=196 Participants
Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
|
|---|---|---|
|
Number of Participants With the Indicated Patency of Infarcted Vessels According to Thrombolysis in Myocardial Infarction (TIMI) Classification Before PCI
TIMI 0/1 patency before PCI
|
117 participants
|
123 participants
|
|
Number of Participants With the Indicated Patency of Infarcted Vessels According to Thrombolysis in Myocardial Infarction (TIMI) Classification Before PCI
TIMI 3 patency before PCI
|
74 participants
|
59 participants
|
|
Number of Participants With the Indicated Patency of Infarcted Vessels According to Thrombolysis in Myocardial Infarction (TIMI) Classification Before PCI
TIMI 2/3 patency before PCI
|
85 participants
|
67 participants
|
SECONDARY outcome
Timeframe: after PCIPopulation: ITT Population
The number of participants with TIMI grade 3 (complete perfusion) patency of the infarcted vessels following PCI, as assessed by core angiography lab, was measured.
Outcome measures
| Measure |
Eptifibatide
n=214 Participants
Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
|
Abciximab
n=196 Participants
Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
|
|---|---|---|
|
Number of Participants With TIMI 3 Patency of Infarcted Vessels Following PCI
|
145 participants
|
137 participants
|
SECONDARY outcome
Timeframe: after PCIPopulation: ITT Population. Participants with un-evaluable angiographies were excluded from analysis.
cTIMI frame counts (number of cineframes needed for dye to reach standardized distal landmarks in a coronary vessel; objective index of coronary blood flow) following PCI, as assessed by core angiography lab.
Outcome measures
| Measure |
Eptifibatide
n=165 Participants
Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
|
Abciximab
n=151 Participants
Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
|
|---|---|---|
|
Mean Number of Corrected TIMI Frame Counts (cTIMI) Following PCI
|
25.3 number of frame counts
Standard Deviation 21.0
|
23.6 number of frame counts
Standard Deviation 17.9
|
SECONDARY outcome
Timeframe: after PCIPopulation: ITT Population
The number of participants with the indicated myocardial blush grade (TMPG), used to assess the myocardial reperfusion in the infarcted myocardium following PCI (as assessed by the core angiography laboratory), was measured. Blush grades: 0 = failure of dye to enter the microvasculature; 1 = dye slowly enters but fails to exit the microvasculature; 2 = delayed entry and exit of dye from the microvasculature; 3: normal entry and exit of dye from the microvasculature. Blush that is of only mild intensity throughout the washout phase but fades minimally is also classified as grade 3.
Outcome measures
| Measure |
Eptifibatide
n=214 Participants
Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
|
Abciximab
n=196 Participants
Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
|
|---|---|---|
|
Number of Participants With the Indicated Myocardial Blush Grade (TIMI Myocardial Perfusion Grade [TMPG]) After PCI
Myocardial blush Grade 3
|
64 participants
|
54 participants
|
|
Number of Participants With the Indicated Myocardial Blush Grade (TIMI Myocardial Perfusion Grade [TMPG]) After PCI
Myocardial blush Grade 2
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Myocardial Blush Grade (TIMI Myocardial Perfusion Grade [TMPG]) After PCI
Myocardial blush Grade 1
|
98 participants
|
96 participants
|
|
Number of Participants With the Indicated Myocardial Blush Grade (TIMI Myocardial Perfusion Grade [TMPG]) After PCI
Myocardial blush Grade 0
|
13 participants
|
11 participants
|
|
Number of Participants With the Indicated Myocardial Blush Grade (TIMI Myocardial Perfusion Grade [TMPG]) After PCI
Not assessable
|
38 participants
|
34 participants
|
SECONDARY outcome
Timeframe: Day 7 or hospital discharge; Day 30 after index-MIPopulation: Safety Population: All participants who received at least one dose of study medication.
The number of participants who died, experienced re-MI, or experienced UTVR (necessity of re-PCI of the target vessel or coronary artery bypass graft \[CABG\] because of recurrent ischaemic angina within 30 days after PCI) within the specified timeframe was measured.
Outcome measures
| Measure |
Eptifibatide
n=226 Participants
Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
|
Abciximab
n=201 Participants
Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
|
|---|---|---|
|
Combined Endpoint: Number of Participants With Events of Death, Re-myocardial Infarction (MI), and Urgent Target Vessel Revascularisation (UTVR)
Death, re-MI, or UTVR until day 7 or discharge
|
12 participants
|
14 participants
|
|
Combined Endpoint: Number of Participants With Events of Death, Re-myocardial Infarction (MI), and Urgent Target Vessel Revascularisation (UTVR)
Death, re-MI, or UTVR until day 30
|
17 participants
|
17 participants
|
SECONDARY outcome
Timeframe: Day 7 or hospital discharge; Day 30 after index-MIPopulation: Safety Population
The number of participants who died, and/or experienced re-MI or UTVR (individually counted) within the specified timeframe was measured.
Outcome measures
| Measure |
Eptifibatide
n=226 Participants
Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
|
Abciximab
n=201 Participants
Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
|
|---|---|---|
|
Number of Participants Who Died, and/or Experienced Re-MI and UTVR (Individually Counted)
Deaths until day 7 or discharge
|
8 participants
|
7 participants
|
|
Number of Participants Who Died, and/or Experienced Re-MI and UTVR (Individually Counted)
Deaths until day 30
|
13 participants
|
7 participants
|
|
Number of Participants Who Died, and/or Experienced Re-MI and UTVR (Individually Counted)
Re-MI until day 7 or discharge
|
0 participants
|
3 participants
|
|
Number of Participants Who Died, and/or Experienced Re-MI and UTVR (Individually Counted)
Re-MI until day 30
|
0 participants
|
5 participants
|
|
Number of Participants Who Died, and/or Experienced Re-MI and UTVR (Individually Counted)
UTVR until day 7 or discharge
|
5 participants
|
8 participants
|
|
Number of Participants Who Died, and/or Experienced Re-MI and UTVR (Individually Counted)
UTVR until day 30
|
5 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Day 7 or hospital discharge; Day 30 after index-MIPopulation: Safety Population
Number of participants who experienced stroke (hemorrhagic, non-hemorrhagic) or major bleedings (TIMI class: intracranial haemorrhage, spontaneous bleeding, bleeding at any instrumented site, retroperitoneal bleeding, or clinically significant overt haemorrhage associated with a drop in haematocrit of ≥ 15% or a drop in haemoglobin of ≥ 5 g/dL).
Outcome measures
| Measure |
Eptifibatide
n=226 Participants
Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
|
Abciximab
n=201 Participants
Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
|
|---|---|---|
|
Number of Participants Who Experienced Stroke or Major Bleeding Complications
Stroke or major bleeding until day 7 or discharge
|
6 participants
|
1 participants
|
|
Number of Participants Who Experienced Stroke or Major Bleeding Complications
Stroke or major bleeding until day 30
|
6 participants
|
2 participants
|
SECONDARY outcome
Timeframe: until 6 Month (Day 180) after index-MIPopulation: Safety Population
The number of participants who died and/or experienced re-MI within 6 month after PCI was measured.
Outcome measures
| Measure |
Eptifibatide
n=226 Participants
Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
|
Abciximab
n=201 Participants
Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
|
|---|---|---|
|
Number of Participants Who Died and or Experienced Re-MI Until 6 Months After PCI
|
15 participants
|
15 participants
|
SECONDARY outcome
Timeframe: until 6 Months (Day 180) after index-MIPopulation: Safety Population
The number of participants with heart failure within 6 month after PCI was measured.
Outcome measures
| Measure |
Eptifibatide
n=226 Participants
Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
|
Abciximab
n=201 Participants
Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
|
|---|---|---|
|
Number of Participants With Heart Failure Until 6 Months After PCI
|
23 participants
|
22 participants
|
SECONDARY outcome
Timeframe: Day 7 or hospital discharge; Day 30 after index-MIPopulation: Safety Population
Number of participants with major bleedings (according to TIMI classification: intracranial haemorrhage, spontaneous bleeding, bleeding at any instrumented site, retroperitoneal bleeding, or clinically significant overt haemorrhage associated with a drop in haematocrit of ≥ 15% or a drop in haemoglobin of ≥ 5 g/dL) within the specified timeframe was measured.
Outcome measures
| Measure |
Eptifibatide
n=226 Participants
Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
|
Abciximab
n=201 Participants
Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
|
|---|---|---|
|
Number of Participants With Major Bleedings (TIMI Classification)
Major bleedings (TIMI classification) until day 7
|
6 participants
|
0 participants
|
|
Number of Participants With Major Bleedings (TIMI Classification)
Major bleedings (TIMI classification) until day 30
|
6 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Day 7 or hospital discharge; Day 30 after index-MIPopulation: Safety Population
The number of participants with minor bleedings (according to TIMI classification: clinically overt bleeding \[e.g., gross haematuria or haematemesis) associated with a drop in haematocrit of ≥ 9% or a drop in haemoglobin of ≥ 3 g/dL) within the specified timeframe was measured.
Outcome measures
| Measure |
Eptifibatide
n=226 Participants
Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
|
Abciximab
n=201 Participants
Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
|
|---|---|---|
|
Number of Participants With Minor Bleedings (TIMI Classification)
Minor bleedings (TIMI classification) until day 7
|
19 participants
|
12 participants
|
|
Number of Participants With Minor Bleedings (TIMI Classification)
Minor bleedings (TIMI classification) until day 30
|
19 participants
|
12 participants
|
SECONDARY outcome
Timeframe: until 6 months after index-MIPopulation: ITT Population
Costs were measured as the duration of stay in the ward (outpatient, normal ward, and intensive care unit) within the specified timeframe was measured.
Outcome measures
| Measure |
Eptifibatide
n=211 Participants
Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
|
Abciximab
n=195 Participants
Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
|
|---|---|---|
|
Mean Duration of Stay in the Ward
|
8.0 days
Standard Deviation 6.7
|
9.7 days
Standard Deviation 11.9
|
Adverse Events
Eptifibatide
Abciximab
Serious adverse events
| Measure |
Eptifibatide
n=226 participants at risk
Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
|
Abciximab
n=201 participants at risk
Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/226
|
0.50%
1/201
|
|
Cardiac disorders
Angina pectoris
|
0.88%
2/226
|
1.00%
2/201
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/226
|
0.50%
1/201
|
|
Cardiac disorders
Cardiac failure
|
0.88%
2/226
|
0.00%
0/201
|
|
Cardiac disorders
Cardiogenic shock
|
1.8%
4/226
|
1.00%
2/201
|
|
Cardiac disorders
In-stent coronary artery restenosis
|
0.44%
1/226
|
0.00%
0/201
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/226
|
1.00%
2/201
|
|
Cardiac disorders
Ventricular fibrillation
|
0.44%
1/226
|
0.00%
0/201
|
|
Cardiac disorders
Ventricular tachycardia
|
0.88%
2/226
|
0.00%
0/201
|
|
Congenital, familial and genetic disorders
Ventricular septal defect
|
0.00%
0/226
|
0.50%
1/201
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.44%
1/226
|
0.00%
0/201
|
|
General disorders
General physical health deterioration
|
0.44%
1/226
|
0.00%
0/201
|
|
General disorders
Malaise
|
0.00%
0/226
|
0.50%
1/201
|
|
General disorders
Non-cardiac chest pain
|
0.44%
1/226
|
0.50%
1/201
|
|
General disorders
Sudden death
|
0.44%
1/226
|
0.00%
0/201
|
|
Infections and infestations
Bronchitis
|
0.44%
1/226
|
0.00%
0/201
|
|
Infections and infestations
Gastrointestinal infection
|
0.44%
1/226
|
0.00%
0/201
|
|
Infections and infestations
Pneumonia
|
0.44%
1/226
|
0.50%
1/201
|
|
Infections and infestations
Sepsis
|
0.00%
0/226
|
0.50%
1/201
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/226
|
0.50%
1/201
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/226
|
0.50%
1/201
|
|
Injury, poisoning and procedural complications
Coronary artery reocclusion
|
0.44%
1/226
|
0.00%
0/201
|
|
Injury, poisoning and procedural complications
In-stent arterial restenosis
|
0.44%
1/226
|
0.00%
0/201
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.44%
1/226
|
0.00%
0/201
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/226
|
0.50%
1/201
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc displacement
|
0.44%
1/226
|
0.00%
0/201
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/226
|
0.50%
1/201
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.44%
1/226
|
0.00%
0/201
|
|
Nervous system disorders
Cerebral hemorrhage
|
0.44%
1/226
|
0.00%
0/201
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/226
|
0.50%
1/201
|
|
Nervous system disorders
Transient ischaemic attack
|
0.44%
1/226
|
0.00%
0/201
|
|
Reproductive system and breast disorders
Testicular pain
|
0.44%
1/226
|
0.00%
0/201
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/226
|
0.50%
1/201
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/226
|
0.50%
1/201
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/226
|
0.50%
1/201
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/226
|
0.50%
1/201
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/226
|
0.50%
1/201
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.44%
1/226
|
0.00%
0/201
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.44%
1/226
|
0.50%
1/201
|
|
Vascular disorders
Aortic dissection
|
0.44%
1/226
|
0.00%
0/201
|
|
Vascular disorders
Haemorrhage
|
0.88%
2/226
|
0.00%
0/201
|
|
Vascular disorders
Shock
|
0.44%
1/226
|
0.00%
0/201
|
Other adverse events
| Measure |
Eptifibatide
n=226 participants at risk
Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
|
Abciximab
n=201 participants at risk
Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
4.9%
11/226
|
2.5%
5/201
|
|
Cardiac disorders
Cardiac failure
|
2.2%
5/226
|
0.00%
0/201
|
|
Cardiac disorders
Ventricular extrasystoles
|
3.1%
7/226
|
2.0%
4/201
|
|
Cardiac disorders
Ventricular tachycardia
|
4.0%
9/226
|
3.0%
6/201
|
|
Injury, poisoning and procedural complications
Post procedural heamatoma
|
5.3%
12/226
|
4.5%
9/201
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
5/226
|
0.00%
0/201
|
|
Nervous system disorders
Headache
|
0.00%
0/226
|
2.0%
4/201
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER