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

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	ST-elevation Myocardial Infarction Infarction, Myocardial
Interventions:	Drug: Abciximab Drug: Eptifibatide

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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

Participant Flow: Overall Study

	Eptifibatide	Abciximab
STARTED	226	203
COMPLETED	204	183
NOT COMPLETED	22	20
Adverse Event	8	1
Lost to Follow-up	7	6
Consent Withdrawn	0	1
Other Reasons	7	12

Baseline Characteristics

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Reporting Groups

	Description
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

Baseline Measures

	Eptifibatide	Abciximab	Total
Number of Participants [units: participants]	214	196	410
Age ^[1] [units: years] Mean ± Standard Deviation	61.3 ± 12.5	60.5 ± 12.7	60.9 ± 12.6
Gender ^[1] [units: participants]
Female	50	39	89
Male	164	157	321

[1]	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.

[1]

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.

Outcome Measures

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1. Primary:

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

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2. Primary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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6. Secondary:

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

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7. Secondary:

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

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8. Secondary:

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

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9. Secondary:

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

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10. Secondary:

Number of Participants With TIMI 3 Patency of Infarcted Vessels Following PCI [ Time Frame: after PCI ]

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11. Secondary:

Mean Number of Corrected TIMI Frame Counts (cTIMI) Following PCI [ Time Frame: after PCI ]

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12. Secondary:

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

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13. Secondary:

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

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14. Secondary:

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

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15. Secondary:

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

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16. Secondary:

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

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17. Secondary:

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

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18. Secondary:

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

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19. Secondary:

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

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20. Secondary:

Mean Duration of Stay in the Ward [ Time Frame: until 6 months after index-MI ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:

Zeymer U, Margenet A, Haude M, Bode C, Lablanche JM, Heuer H, Schröder 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.

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00426751 History of Changes
Other Study ID Numbers:	106915
Study First Received:	January 24, 2007
Results First Received:	April 6, 2010
Last Updated:	May 17, 2012
Health Authority:	Germany: German Institute of Medical Documentation and Information