Efficacy Of Eptifibatide Compared To Abciximab In Primary... | NCT00426751

Status Module

Label	Type	Description	Intervention Names
Abciximab	Active Comparator	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
Eptifibatide	Experimental	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

Name	Type	Description	Arm Group Labels	Other Names
Abciximab	Drug	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.	Abciximab

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Complete or Partial Sum ST Resolution (STR) 60 Min After PCI	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).

Eligibility Module

Eligibility Criteria

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.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Alençon		61014	France
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
20670755	Derived	Zeymer U, Margenet A, Haude M, Bode C, Lablanche JM, Heuer H, Schroder R, Kropff S, Bourkaib R, Banik N, Zahn R, Teiger E. Randomized comparison of eptifibatide versus abciximab in primary percutaneous coronary intervention in patients with acute ST-segment elevation myocardial infarction: results of the EVA-AMI Trial. J Am Coll Cardiol. 2010 Aug 3;56(6):463-9. doi: 10.1016/j.jacc.2009.08.093.

ID	Title	Description
FG000	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
FG001

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Twelve participants in the eptifibatide group and 6 participants in the abciximab group were excluded from the Intent-to-Treat (ITT) and Per Protocol (PP) Populations due to uncertain infarct localization. One of these participants in the abciximab group had not received study medication and was also excluded from safety analysis. One additional participant in the abciximab group had not received study medication and was also excluded from safety analysis.

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG00071 OG00165

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Median Difference (Final Values)	2.1				90	-8.5	12.8				Yes	Non-Inferiority or Equivalence	For the assessment of differences between both treatment groups, a generalized model (under binomial probability distribution), adjusted for center, was applied.

Primary

Number of Participants With Complete Sum ST Resolution (STR) 60 Min After Percutaneous Coronary Intervention (PCI) (Intent-to-Treat Population)

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

Posted

Number

participants

Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)

ID	Title	Description
OG000	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
OG001	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

Units	Counts

Secondary

Number of Participants With Complete or Partial Sum ST Resolution (STR) 60 Min After PCI

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).

ITT Population

Posted

Number

participants

Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants

Secondary

Number of Participants With Complete Single Lead ST Resolution (STR) 60 Min After PCI

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%).

ITT Population

Posted

Number

participants

Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants

Secondary

Mean Change From Baseline in the Sum ST Resolution 60 Min After PCI

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.

Posted

Mean

Standard Deviation

percent change

Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)

ID	Title	Description
OG000	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
OG001	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

Units	Counts

Secondary

Mean Change From Baseline in Single Lead ST Resolution (STR) 60 Min After PCI

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.

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

Posted

Mean

Standard Deviation

percent change

Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)

ID	Title	Description
OG000	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
OG001	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

Units	Counts

Secondary

Mean Change From Baseline in the Sum ST Resolution (STR) Before PCI

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.

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

Posted

Mean

Standard Deviation

percent change

Baseline (ECG I) and immediately prior to PCI (ECG II)

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants

Secondary

Mean Maximum ST Deviation Existing (Max STE) 60 Min After PCI

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).

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

Posted

Mean

Standard Deviation

millimeters (mm)

60 min +/- 15 min after PCI (ECG III)

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants

Secondary

Number of Participants With the Indicated Patency of Infarcted Vessels According to Thrombolysis in Myocardial Infarction (TIMI) Classification 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.

ITT Population

Posted

Number

participants

immediately before PCI

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants

Secondary

Number of Participants With TIMI 3 Patency of Infarcted Vessels Following 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.

ITT Population

Posted

Number

participants

after PCI

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Secondary

Mean Number of Corrected TIMI Frame Counts (cTIMI) Following 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.

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

Posted

Mean

Standard Deviation

number of frame counts

after PCI

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants

Secondary

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

ITT Population

Posted

Number

participants

after PCI

ID	Title	Description
OG000	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
OG001	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

Secondary

Combined Endpoint: Number of Participants With Events of Death, Re-myocardial Infarction (MI), and Urgent Target Vessel Revascularisation (UTVR)

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.

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

Posted

Number

participants

Day 7 or hospital discharge; Day 30 after index-MI

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants

Secondary

Number of Participants Who Died, and/or Experienced Re-MI and UTVR (Individually Counted)

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

Safety Population

Posted

Number

participants

Day 7 or hospital discharge; Day 30 after index-MI

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Secondary

Number of Participants Who Experienced Stroke or Major Bleeding Complications

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).

Safety Population

Posted

Number

participants

Day 7 or hospital discharge; Day 30 after index-MI

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants

Secondary

Number of Participants Who Died and or Experienced Re-MI Until 6 Months After PCI

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

Safety Population

Posted

Number

participants

until 6 Month (Day 180) after index-MI

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Secondary

Number of Participants With Heart Failure Until 6 Months After PCI

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

Safety Population

Posted

Number

participants

until 6 Months (Day 180) after index-MI

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Secondary

Number of Participants With Major Bleedings (TIMI Classification)

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.

Safety Population

Posted

Number

participants

Day 7 or hospital discharge; Day 30 after index-MI

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants

Secondary

Number of Participants With Minor Bleedings (TIMI Classification)

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.](streamdown:incomplete-link)

Safety Population

Posted

Number

participants

Day 7 or hospital discharge; Day 30 after index-MI

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants

Secondary

Mean Duration of Stay in the Ward

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

ITT Population

Posted

Mean

Standard Deviation

days

until 6 months after index-MI

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected226 at risk EG0011 affected201 at risk
Angina pectoris	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected226 at risk EG0012 affected201 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected226 at risk EG0011 affected201 at risk
Cardiac failure	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected226 at risk EG0010 affected201 at risk
Cardiogenic shock	Cardiac disorders	MedDRA	Systematic Assessment	EG0004 affected226 at risk EG0012 affected201 at risk
In-stent coronary artery restenosis	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected226 at risk EG0010 affected201 at risk
Pericardial effusion	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected226 at risk EG0012 affected201 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected226 at risk EG0010 affected201 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected226 at risk EG0010 affected201 at risk
Ventricular septal defect	Congenital, familial and genetic disorders	MedDRA	Systematic Assessment	EG0000 affected226 at risk EG0011 affected201 at risk
Gastrointestinal hemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected226 at risk EG0010 affected201 at risk
General physical health deterioration	General disorders	MedDRA	Systematic Assessment	EG0001 affected226 at risk EG0010 affected201 at risk
Malaise	General disorders	MedDRA	Systematic Assessment	EG0000 affected226 at risk EG0011 affected201 at risk
Non-cardiac chest pain	General disorders	MedDRA	Systematic Assessment	EG0001 affected226 at risk EG0011 affected201 at risk
Sudden death	General disorders	MedDRA	Systematic Assessment	EG0001 affected226 at risk EG0010 affected201 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected226 at risk EG0010 affected201 at risk
Gastrointestinal infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected226 at risk EG0010 affected201 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected226 at risk EG0011 affected201 at risk
Sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected226 at risk EG0011 affected201 at risk
Staphylococcal infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected226 at risk EG0011 affected201 at risk
Tracheobronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected226 at risk EG0011 affected201 at risk
Coronary artery reocclusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected226 at risk EG0010 affected201 at risk
In-stent arterial restenosis	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected226 at risk EG0010 affected201 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected226 at risk EG0010 affected201 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected226 at risk EG0011 affected201 at risk
Intervertebral disc displacement	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected226 at risk EG0010 affected201 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected226 at risk EG0011 affected201 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected226 at risk EG0010 affected201 at risk
Cerebral hemorrhage	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected226 at risk EG0010 affected201 at risk
Ischaemic stroke	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected226 at risk EG0011 affected201 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected226 at risk EG0010 affected201 at risk
Testicular pain	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected226 at risk EG0010 affected201 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected226 at risk EG0011 affected201 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected226 at risk EG0011 affected201 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected226 at risk EG0011 affected201 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected226 at risk EG0011 affected201 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected226 at risk EG0011 affected201 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected226 at risk EG0010 affected201 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected226 at risk EG0011 affected201 at risk
Aortic dissection	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected226 at risk EG0010 affected201 at risk
Haemorrhage	Vascular disorders	MedDRA	Systematic Assessment	EG0002 affected226 at risk EG0010 affected201 at risk
Shock	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected226 at risk EG0010 affected201 at risk

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases
D007238	Infarction
D007511	Ischemia
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009336	Necrosis

ID	Term
D007140	Immunoglobulin Fab Fragments
D007128	Immunoglobulin Fragments
D010446	Peptide Fragments
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D012712	Serum Globulins
D005916	Globulins
D010456	Peptides, Cyclic

ID	Title	Description
BG000	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
BG001	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
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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			24	226	49	226
EG001	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			19	201	28	201

ID	Term
D009203	Myocardial Infarction
D000072657	ST Elevation Myocardial Infarction