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

Primary Purpose

Infarction, Myocardial

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Abciximab
Eptifibatide
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infarction, Myocardial focused on measuring Eptifibatide, ST-elevation Myocardial Infarction, STEMI, Abciximab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Abciximab

Eptifibatide

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

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).
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%).
Mean Change From Baseline in the Sum ST Resolution 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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.

Full Information

First Posted
January 24, 2007
Last Updated
November 21, 2012
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00426751
Brief Title
Efficacy Of Eptifibatide Compared To Abciximab In Primary Percutaneous Coronary Intervention (PCI) For Acute ST Elevation Myocardial Infarction (STEMI)
Official Title
Eptifibatide Versus Abciximab in Primary PCI for Acute ST Elevation Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infarction, Myocardial
Keywords
Eptifibatide, ST-elevation Myocardial Infarction, STEMI, Abciximab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
429 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Abciximab
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Eptifibatide
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Abciximab
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Eptifibatide
Other Intervention Name(s)
Abciximab
Intervention Description
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.
Primary Outcome Measure Information:
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)
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)
Secondary Outcome Measure Information:
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)
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)
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)
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)
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)
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)
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
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
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
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
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
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
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
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
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
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
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: Angina or equivalent symptoms > 20 min and 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Alençon
ZIP/Postal Code
61014
Country
France
Facility Name
GSK Investigational Site
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
GSK Investigational Site
City
Caen Cedex 5
ZIP/Postal Code
14033
Country
France
Facility Name
GSK Investigational Site
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
GSK Investigational Site
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
GSK Investigational Site
City
Melun
ZIP/Postal Code
77000
Country
France
Facility Name
GSK Investigational Site
City
Melun
ZIP/Postal Code
77007
Country
France
Facility Name
GSK Investigational Site
City
Nancy
ZIP/Postal Code
54000
Country
France
Facility Name
GSK Investigational Site
City
Ollioules
ZIP/Postal Code
83190
Country
France
Facility Name
GSK Investigational Site
City
Pau
ZIP/Postal Code
64046
Country
France
Facility Name
GSK Investigational Site
City
Perpignan
ZIP/Postal Code
66000
Country
France
Facility Name
GSK Investigational Site
City
Pessac Cedex
ZIP/Postal Code
33604
Country
France
Facility Name
GSK Investigational Site
City
Toulon
ZIP/Postal Code
83056
Country
France
Facility Name
GSK Investigational Site
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
GSK Investigational Site
City
Freiburg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
79106
Country
Germany
Facility Name
GSK Investigational Site
City
Heidelberg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
GSK Investigational Site
City
Wuerzburg
State/Province
Bayern
ZIP/Postal Code
97080
Country
Germany
Facility Name
GSK Investigational Site
City
Offenbach
State/Province
Hessen
ZIP/Postal Code
63069
Country
Germany
Facility Name
GSK Investigational Site
City
Aachen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
52074
Country
Germany
Facility Name
GSK Investigational Site
City
Dortmund
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44137
Country
Germany
Facility Name
GSK Investigational Site
City
Moenchengladbach
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
41063
Country
Germany
Facility Name
GSK Investigational Site
City
Neuss
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
41464
Country
Germany
Facility Name
GSK Investigational Site
City
Ludwigshafen
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67063
Country
Germany
Facility Name
GSK Investigational Site
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
20670755
Citation
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.
Results Reference
derived

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

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