Efficacy Of Eptifibatide Compared To Abciximab In Primary Percutaneous Coronary Intervention (PCI) For Acute ST Elevation Myocardial Infarction (STEMI)

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00426751
• Collaborator: (none)
• Enrollment: 429
• Locations: 24
• Arms: 2
• Duration (Months): 14
• Patients Per Site: 17.9
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

Multinational, multicentre, randomised, prospective, open, parallel group study directly comparing two glycoprotein-IIb/IIIa inhibitors, abciximab and eptifibatide, added early to standard treatment before primary PCI of STEMI patients with respect to effect on sum-ST-resolution after 60 minutes post-procedure and other measures of myocardial reperfusion

Condition or Disease	Intervention/Treatment	Phase
Infarction, Myocardial	Drug: Abciximab; Drug: Eptifibatide	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 429 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Eptifibatide Versus Abciximab in Primary PCI for Acute ST Elevation Myocardial Infarction
• Study Start Date: Oct 1, 2006
• Actual Primary Completion Date: Dec 1, 2007
• Actual Study Completion Date: Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Abciximab Intravenous bolus of 0.25 mg/kg followed by continuous intravenous infusion of 0.125 mcg/kg/min (max. 10 mcg/min) for 12 h after PCI.	Drug: Abciximab; Intravenous bolus of 0.25 mg/kg followed by continuous intravenous infusion of 0.125 mcg/kg/min (max. 10 mcg/min) for 12 h after PCI.
Experimental: Eptifibatide Intravenous bolus of 180 mcg/kg followed immediately by a continuous infusion of 2.0 mcg/kg/ min for 20-24 h after end of PCI, and a second bolus of 180 mcg/kg administered 10 min after the first bolus.	Drug: Eptifibatide; Intravenous bolus of 180 mcg/kg followed immediately by a continuous infusion of 2.0 mdg/kg/ min for 20-24 h after end of PCI, and a second bolus of 180 mcg/kg administered 10 min after the first bolus.; Other Names: Abciximab

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Complete Sum ST Resolution (STR) 60 Minutes (Min) After Percutaneous Coronary Intervention (PCI) (Per Protocol Population) [Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)]

   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).

2. Number of Participants With Complete Sum ST Resolution (STR) 60 Min After Percutaneous Coronary Intervention (PCI) (Intent-to-Treat Population) [Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)]

   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).

Secondary Outcome Measures

1. Number of Participants With Complete or Partial Sum ST Resolution (STR) 60 Min After PCI [Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)]

   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).

2. Number of Participants With Complete Single Lead ST Resolution (STR) 60 Min After PCI [Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)]

   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%).

3. Mean Change From Baseline in the Sum ST Resolution 60 Min After PCI [Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)]

   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.

4. Mean Change From Baseline in Single Lead ST Resolution (STR) 60 Min After PCI [Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)]

   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.

5. Mean Change From Baseline in the Sum ST Resolution (STR) Before PCI [Baseline (ECG I) and immediately prior to PCI (ECG II)]

   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.

6. Mean Maximum ST Deviation Existing (Max STE) 60 Min After PCI [60 min +/- 15 min after PCI (ECG III)]

   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).

7. Number of Participants With the Indicated Patency of Infarcted Vessels According to Thrombolysis in Myocardial Infarction (TIMI) Classification Before PCI [immediately before PCI]

   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.

8. Number of Participants With TIMI 3 Patency of Infarcted Vessels Following PCI [after PCI]

   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.

9. Mean Number of Corrected TIMI Frame Counts (cTIMI) Following PCI [after PCI]

   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.

10. Number of Participants With the Indicated Myocardial Blush Grade (TIMI Myocardial Perfusion Grade [TMPG]) After PCI [after PCI]

    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.

11. Combined Endpoint: Number of Participants With Events of Death, Re-myocardial Infarction (MI), and Urgent Target Vessel Revascularisation (UTVR) [Day 7 or hospital discharge; Day 30 after index-MI]

    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.

12. Number of Participants Who Died, and/or Experienced Re-MI and UTVR (Individually Counted) [Day 7 or hospital discharge; Day 30 after index-MI]

    The number of participants who died, and/or experienced re-MI or UTVR (individually counted) within the specified timeframe was measured.

13. Number of Participants Who Experienced Stroke or Major Bleeding Complications [Day 7 or hospital discharge; Day 30 after index-MI]

    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).

14. Number of Participants Who Died and or Experienced Re-MI Until 6 Months After PCI [until 6 Month (Day 180) after index-MI]

    The number of participants who died and/or experienced re-MI within 6 month after PCI was measured.

15. Number of Participants With Heart Failure Until 6 Months After PCI [until 6 Months (Day 180) after index-MI]

    The number of participants with heart failure within 6 month after PCI was measured.

16. Number of Participants With Major Bleedings (TIMI Classification) [Day 7 or hospital discharge; Day 30 after index-MI]

    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.

17. Number of Participants With Minor Bleedings (TIMI Classification) [Day 7 or hospital discharge; Day 30 after index-MI]

    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.

18. Mean Duration of Stay in the Ward [until 6 months after index-MI]

    Costs were measured as the duration of stay in the ward (outpatient, normal ward, and intensive care unit) within the specified timeframe was measured.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Women must be postmenopausal (i.e.12 months without menstrual period), or surgically sterile, i.e. women of child bearing potential are not allowed to be included into the study. In cases of doubt a pregnancy test should be performed. (NB -post menopausal women currently receiving hormone replacement are permissible)

• Acute myocardial infarction < 12 h defined as:

1. Angina or equivalent symptoms > 20 min and

2. ST elevation in 2 contiguous ECG leads (= 2 mm precordial lead, = 1 mm limb lead). This ECG recording serves as baseline ECG, i.e. ECG I.

• Planned primary percutaneous coronary intervention

• The subject has given written informed, dated consent to participate in the study

Exclusion Criteria:

• Subjects not able to give informed consent

• Left Bundle Branch Block

• Thrombolytic therapy within 24 hours before randomization

• Oral anticoagulation with International Normalized Ratio (INR) > 2

• Known platelets < 100.000/µl or known hemorrhagic diathesis

• Stroke or Transient Ischemic Attack (TIA) within the past 6 months or any permanent residual neurological defect

• Evidence of an active gastrointestinal or urogenital bleeding

• Major surgery within 6 weeks

• History of allergic reaction to abciximab or eptifibatide or any component used in the study (including contrast media)

• Known severe renal (creatinine clearance <30ml/min) or hepatic insufficiency as well as Alanine transaminase (ALT)/aspartate transaminase (AST) elevations = 3xUpper limit normal (ULN); isolated AST-elevation is not considered an exclusion criteria from study participation

• Severe concomitant disease with life expectation < 1 year

• Subject has participated in any study using an investigational drug or device within 30 days or within 5 half-lives of the investigational drug (whichever is longer) of entry into this study.

• Subjects who will be inaccessible due to geographic or social factors during treatment or follow-up

• In France, a subject is neither affiliated with nor a beneficiary of a social security category.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Alençon		France	61014
2	GSK Investigational Site	Bordeaux		France	33076
3	GSK Investigational Site	Caen Cedex 5		France	14033
4	GSK Investigational Site	Créteil		France	94010
5	GSK Investigational Site	Lille		France	59037
6	GSK Investigational Site	Melun		France	77000
7	GSK Investigational Site	Melun		France	77007
8	GSK Investigational Site	Nancy		France	54000
9	GSK Investigational Site	Ollioules		France	83190
10	GSK Investigational Site	Pau		France	64046
11	GSK Investigational Site	Perpignan		France	66000
12	GSK Investigational Site	Pessac Cedex		France	33604
13	GSK Investigational Site	Toulon		France	83056
14	GSK Investigational Site	Vandoeuvre Les Nancy		France	54511
15	GSK Investigational Site	Freiburg	Baden-Wuerttemberg	Germany	79106
16	GSK Investigational Site	Heidelberg	Baden-Wuerttemberg	Germany	69120
17	GSK Investigational Site	Wuerzburg	Bayern	Germany	97080
18	GSK Investigational Site	Offenbach	Hessen	Germany	63069
19	GSK Investigational Site	Aachen	Nordrhein-Westfalen	Germany	52074
20	GSK Investigational Site	Dortmund	Nordrhein-Westfalen	Germany	44137
21	GSK Investigational Site	Moenchengladbach	Nordrhein-Westfalen	Germany	41063
22	GSK Investigational Site	Neuss	Nordrhein-Westfalen	Germany	41464
23	GSK Investigational Site	Ludwigshafen	Rheinland-Pfalz	Germany	67063
24	GSK Investigational Site	Homburg	Saarland	Germany	66421

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00426751
• Other Study ID Numbers: 106915
• First Posted: Jan 25, 2007
• Last Update Posted: Nov 27, 2012
• Last Verified: Nov 1, 2012

• Keywords provided by GlaxoSmithKline: Eptifibatide; ST-elevation Myocardial Infarction; STEMI; Abciximab
• Additional relevant MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction; Abciximab; Eptifibatide

Study Results

Participant Flow

Arm/Group Title	Eptifibatide	Abciximab
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	226	203
COMPLETED	204	183
NOT COMPLETED	22	20

Baseline Characteristics

Arm/Group Title	Eptifibatide	Abciximab	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	214	196	410
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.3 (12.5)	60.5 (12.7)	60.9 (12.6)
Sex: Female, Male (Count of Participants)
Female	50 23.4%	39 19.9%	89 21.7%
Male	164 76.6%	157 80.1%	321 78.3%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Complete Sum ST Resolution (STR) 60 Minutes (Min) After Percutaneous Coronary Intervention (PCI) (Per Protocol Population)
Description	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).
Time Frame	Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Eptifibatide	Abciximab
Arm/Group Description	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	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
Measure Participants	113	111
Number [participants]	71 33.2%	65 33.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Eptifibatide, Abciximab
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	For the assessment of differences between both treatment groups, a generalized model (under binomial probability distribution), adjusted for center, was applied.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	2.1
	Confidence Interval	() 90%; -8.5 to 12.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Number of Participants With Complete Sum ST Resolution (STR) 60 Min After Percutaneous Coronary Intervention (PCI) (Intent-to-Treat Population)
Description	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).
Time Frame	Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) Population: All randomized participants who received at least one dose of study medication.

Arm/Group Title	Eptifibatide	Abciximab
Arm/Group Description	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	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
Measure Participants	214	196
Number [participants]	124 57.9%	103 52.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Eptifibatide, Abciximab
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	For the assessment of differences between both treatment groups a generalised model (under binomial probability distribution), adjusted for centre, was applied.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.8
	Confidence Interval	() 95%; -3.0 to 16.6
	Parameter Dispersion	Type: Value:
	Estimation Comments	Analysis based on the ITT population confirmed the results observed in the PP population.

3. Secondary Outcome

Title	Number of Participants With Complete or Partial Sum ST Resolution (STR) 60 Min After PCI
Description	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).
Time Frame	Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Eptifibatide	Abciximab
Arm/Group Description	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	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
Measure Participants	214	196
Complete sum STR( ≥70%)	124 57.9%	103 52.6%
Complete or partial sum STR (≥30%)	180 84.1%	154 78.6%
Partial sum STR (≥30% and <70%)	56 26.2%	51 26%
No sum STR (<30%)	34 15.9%	42 21.4%

4. Secondary Outcome

Title	Number of Participants With Complete Single Lead ST Resolution (STR) 60 Min After PCI
Description	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%).
Time Frame	Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Eptifibatide	Abciximab
Arm/Group Description	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	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
Measure Participants	214	196
Number [participants]	105 49.1%	82 41.8%

5. Secondary Outcome

Title	Mean Change From Baseline in the Sum ST Resolution 60 Min After PCI
Description	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.
Time Frame	Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Eptifibatide	Abciximab
Arm/Group Description	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	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
Measure Participants	198	183
Mean (Standard Deviation) [percent change]	71.6 (27.2)	66.3 (31.1)

6. Secondary Outcome

Title	Mean Change From Baseline in Single Lead ST Resolution (STR) 60 Min After PCI
Description	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.
Time Frame	Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)

Outcome Measure Data

Analysis Population Description

ITT Population. Participants with unevaluable ECGs were excluded from analysis.

Arm/Group Title	Eptifibatide	Abciximab
Arm/Group Description	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	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
Measure Participants	176	167
Mean (Standard Deviation) [percent change]	70.2 (25.5)	64.0 (28.7)

7. Secondary Outcome

Title	Mean Change From Baseline in the Sum ST Resolution (STR) Before PCI
Description	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.
Time Frame	Baseline (ECG I) and immediately prior to PCI (ECG II)

Outcome Measure Data

Analysis Population Description

ITT Population. Participants who did not have an ECG II immediately before PCI were excluded from analysis.

Arm/Group Title	Eptifibatide	Abciximab
Arm/Group Description	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	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
Measure Participants	145	120
Mean (Standard Deviation) [percent change]	25.9 (32.0)	21.2 (29.0)

8. Secondary Outcome

Title	Mean Maximum ST Deviation Existing (Max STE) 60 Min After PCI
Description	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).
Time Frame	60 min +/- 15 min after PCI (ECG III)

Outcome Measure Data

Analysis Population Description

ITT Population. Participants with unevaluable ECGs were excluded from analysis.

Arm/Group Title	Eptifibatide	Abciximab
Arm/Group Description	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	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
Measure Participants	180	172
Mean (Standard Deviation) [millimeters (mm)]	1.1 (1.1)	1.4 (1.4)

9. Secondary Outcome

Title	Number of Participants With the Indicated Patency of Infarcted Vessels According to Thrombolysis in Myocardial Infarction (TIMI) Classification Before PCI
Description	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.
Time Frame	immediately before PCI

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Eptifibatide	Abciximab
Arm/Group Description	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	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
Measure Participants	214	196
TIMI 3 patency before PCI	74 34.6%	59 30.1%
TIMI 2/3 patency before PCI	85 39.7%	67 34.2%
TIMI 0/1 patency before PCI	117 54.7%	123 62.8%

10. Secondary Outcome

Title	Number of Participants With TIMI 3 Patency of Infarcted Vessels Following PCI
Description	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.
Time Frame	after PCI

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Eptifibatide	Abciximab
Arm/Group Description	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	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
Measure Participants	214	196
Number [participants]	145 67.8%	137 69.9%

11. Secondary Outcome

Title	Mean Number of Corrected TIMI Frame Counts (cTIMI) Following PCI
Description	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.
Time Frame	after PCI

Outcome Measure Data

Analysis Population Description

ITT Population. Participants with un-evaluable angiographies were excluded from analysis.

Arm/Group Title	Eptifibatide	Abciximab
Arm/Group Description	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	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
Measure Participants	165	151
Mean (Standard Deviation) [number of frame counts]	25.3 (21.0)	23.6 (17.9)

12. Secondary Outcome

Title	Number of Participants With the Indicated Myocardial Blush Grade (TIMI Myocardial Perfusion Grade [TMPG]) After PCI
Description	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.
Time Frame	after PCI

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Eptifibatide	Abciximab
Arm/Group Description	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	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
Measure Participants	214	196
Myocardial blush Grade 3	64 29.9%	54 27.6%
Myocardial blush Grade 2	0 0%	0 0%
Myocardial blush Grade 1	98 45.8%	96 49%
Myocardial blush Grade 0	13 6.1%	11 5.6%
Not assessable	38 17.8%	34 17.3%

13. Secondary Outcome

Title	Combined Endpoint: Number of Participants With Events of Death, Re-myocardial Infarction (MI), and Urgent Target Vessel Revascularisation (UTVR)
Description	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.
Time Frame	Day 7 or hospital discharge; Day 30 after index-MI

Outcome Measure Data

Analysis Population Description

Safety Population: All participants who received at least one dose of study medication.

Arm/Group Title	Eptifibatide	Abciximab
Arm/Group Description	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	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
Measure Participants	226	201
Death, re-MI, or UTVR until day 7 or discharge	12 5.6%	14 7.1%
Death, re-MI, or UTVR until day 30	17 7.9%	17 8.7%

14. Secondary Outcome

Title	Number of Participants Who Died, and/or Experienced Re-MI and UTVR (Individually Counted)
Description	The number of participants who died, and/or experienced re-MI or UTVR (individually counted) within the specified timeframe was measured.
Time Frame	Day 7 or hospital discharge; Day 30 after index-MI

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Eptifibatide	Abciximab
Arm/Group Description	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	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
Measure Participants	226	201
Deaths until day 7 or discharge	8 3.7%	7 3.6%
Deaths until day 30	13 6.1%	7 3.6%
Re-MI until day 7 or discharge	0 0%	3 1.5%
Re-MI until day 30	0 0%	5 2.6%
UTVR until day 7 or discharge	5 2.3%	8 4.1%
UTVR until day 30	5 2.3%	10 5.1%

15. Secondary Outcome

Title	Number of Participants Who Experienced Stroke or Major Bleeding Complications
Description	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).
Time Frame	Day 7 or hospital discharge; Day 30 after index-MI

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Eptifibatide	Abciximab
Arm/Group Description	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	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
Measure Participants	226	201
Stroke or major bleeding until day 7 or discharge	6 2.8%	1 0.5%
Stroke or major bleeding until day 30	6 2.8%	2 1%

16. Secondary Outcome

Title	Number of Participants Who Died and or Experienced Re-MI Until 6 Months After PCI
Description	The number of participants who died and/or experienced re-MI within 6 month after PCI was measured.
Time Frame	until 6 Month (Day 180) after index-MI

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Eptifibatide	Abciximab
Arm/Group Description	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	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
Measure Participants	226	201
Number [participants]	15 7%	15 7.7%

17. Secondary Outcome

Title	Number of Participants With Heart Failure Until 6 Months After PCI
Description	The number of participants with heart failure within 6 month after PCI was measured.
Time Frame	until 6 Months (Day 180) after index-MI

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Eptifibatide	Abciximab
Arm/Group Description	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	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
Measure Participants	226	201
Number [participants]	23 10.7%	22 11.2%

18. Secondary Outcome

Title	Number of Participants With Major Bleedings (TIMI Classification)
Description	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.
Time Frame	Day 7 or hospital discharge; Day 30 after index-MI

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Eptifibatide	Abciximab
Arm/Group Description	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	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
Measure Participants	226	201
Major bleedings (TIMI classification) until day 7	6 2.8%	0 0%
Major bleedings (TIMI classification) until day 30	6 2.8%	1 0.5%

19. Secondary Outcome

Title	Number of Participants With Minor Bleedings (TIMI Classification)
Description	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.
Time Frame	Day 7 or hospital discharge; Day 30 after index-MI

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Eptifibatide	Abciximab
Arm/Group Description	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	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
Measure Participants	226	201
Minor bleedings (TIMI classification) until day 7	19 8.9%	12 6.1%
Minor bleedings (TIMI classification) until day 30	19 8.9%	12 6.1%

20. Secondary Outcome

Title	Mean Duration of Stay in the Ward
Description	Costs were measured as the duration of stay in the ward (outpatient, normal ward, and intensive care unit) within the specified timeframe was measured.
Time Frame	until 6 months after index-MI

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Eptifibatide	Abciximab
Arm/Group Description	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	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
Measure Participants	211	195
Mean (Standard Deviation) [days]	8.0 (6.7)	9.7 (11.9)

Adverse Events

Arm/Group Title	Eptifibatide		Abciximab
Arm/Group Description	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		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
All Cause Mortality
	Eptifibatide		Abciximab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Eptifibatide		Abciximab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	24/226 (10.6%)		19/201 (9.5%)
Cardiac disorders
Acute myocardial infarction	0/226 (0%)		1/201 (0.5%)
Angina pectoris	2/226 (0.9%)		2/201 (1%)
Atrioventricular block complete	0/226 (0%)		1/201 (0.5%)
Cardiac failure	2/226 (0.9%)		0/201 (0%)
Cardiogenic shock	4/226 (1.8%)		2/201 (1%)
In-stent coronary artery restenosis	1/226 (0.4%)		0/201 (0%)
Pericardial effusion	0/226 (0%)		2/201 (1%)
Ventricular fibrillation	1/226 (0.4%)		0/201 (0%)
Ventricular tachycardia	2/226 (0.9%)		0/201 (0%)
Congenital, familial and genetic disorders
Ventricular septal defect	0/226 (0%)		1/201 (0.5%)
Gastrointestinal disorders
Gastrointestinal hemorrhage	1/226 (0.4%)		0/201 (0%)
General disorders
General physical health deterioration	1/226 (0.4%)		0/201 (0%)
Malaise	0/226 (0%)		1/201 (0.5%)
Non-cardiac chest pain	1/226 (0.4%)		1/201 (0.5%)
Sudden death	1/226 (0.4%)		0/201 (0%)
Infections and infestations
Bronchitis	1/226 (0.4%)		0/201 (0%)
Gastrointestinal infection	1/226 (0.4%)		0/201 (0%)
Pneumonia	1/226 (0.4%)		1/201 (0.5%)
Sepsis	0/226 (0%)		1/201 (0.5%)
Staphylococcal infection	0/226 (0%)		1/201 (0.5%)
Tracheobronchitis	0/226 (0%)		1/201 (0.5%)
Injury, poisoning and procedural complications
Coronary artery reocclusion	1/226 (0.4%)		0/201 (0%)
In-stent arterial restenosis	1/226 (0.4%)		0/201 (0%)
Post procedural haematoma	1/226 (0.4%)		0/201 (0%)
Metabolism and nutrition disorders
Diabetes mellitus	0/226 (0%)		1/201 (0.5%)
Musculoskeletal and connective tissue disorders
Intervertebral disc displacement	1/226 (0.4%)		0/201 (0%)
Musculoskeletal chest pain	0/226 (0%)		1/201 (0.5%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer	1/226 (0.4%)		0/201 (0%)
Nervous system disorders
Cerebral hemorrhage	1/226 (0.4%)		0/201 (0%)
Ischaemic stroke	0/226 (0%)		1/201 (0.5%)
Transient ischaemic attack	1/226 (0.4%)		0/201 (0%)
Reproductive system and breast disorders
Testicular pain	1/226 (0.4%)		0/201 (0%)
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema	0/226 (0%)		1/201 (0.5%)
Chronic obstructive pulmonary disease	0/226 (0%)		1/201 (0.5%)
Dyspnoea	0/226 (0%)		1/201 (0.5%)
Dyspnoea exertional	0/226 (0%)		1/201 (0.5%)
Pneumonia aspiration	0/226 (0%)		1/201 (0.5%)
Pneumothorax	1/226 (0.4%)		0/201 (0%)
Pulmonary oedema	1/226 (0.4%)		1/201 (0.5%)
Vascular disorders
Aortic dissection	1/226 (0.4%)		0/201 (0%)
Haemorrhage	2/226 (0.9%)		0/201 (0%)
Shock	1/226 (0.4%)		0/201 (0%)
Other (Not Including Serious) Adverse Events
	Eptifibatide		Abciximab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	49/226 (21.7%)		28/201 (13.9%)
Cardiac disorders
Angina pectoris	11/226 (4.9%)		5/201 (2.5%)
Cardiac failure	5/226 (2.2%)		0/201 (0%)
Ventricular extrasystoles	7/226 (3.1%)		4/201 (2%)
Ventricular tachycardia	9/226 (4%)		6/201 (3%)
Injury, poisoning and procedural complications
Post procedural heamatoma	12/226 (5.3%)		9/201 (4.5%)
Musculoskeletal and connective tissue disorders
Back pain	5/226 (2.2%)		0/201 (0%)
Nervous system disorders
Headache	0/226 (0%)		4/201 (2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.