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.
Status
Completed
Phase
Phase 3
Enrollment
429
Locations
24
Results
Posted
Publications
1
Study 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
Interventions
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.
DRUG
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.
Timeline
First posted
Jan 25, 2007
Study start
Oct 2006
Primary completion
Dec 2007
Study completion
Dec 2007
Results posted
Apr 26, 2010
Registry updated
Nov 27, 2012
Outcomes
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)
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)
Time frame · 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).
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)
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
Time frame · 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%).
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)
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
Time frame · 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.
Mean Change From Baseline in the Sum ST Resolution (STR) Before PCI
Time frame · 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.
Mean Maximum ST Deviation Existing (Max STE) 60 Min After PCI
Time frame · 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).
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
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
Time frame · 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.
Mean Number of Corrected TIMI Frame Counts (cTIMI) Following PCI
Time frame · 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.
Number of Participants With the Indicated Myocardial Blush Grade (TIMI Myocardial Perfusion Grade [TMPG]) After PCI
Time frame · 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.
Eligibility
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.
Study locations
France · Germany. Showing up to 24 locations stored in the fast local snapshot.
GSK Investigational Site
Alençon, France
GSK Investigational Site
Bordeaux, France
GSK Investigational Site
Caen, France
GSK Investigational Site
Créteil, France
GSK Investigational Site
Lille, France
GSK Investigational Site
Melun, France
GSK Investigational Site
Melun, France
GSK Investigational Site
Nancy, France
GSK Investigational Site
Ollioules, France
GSK Investigational Site
Pau, France
GSK Investigational Site
Perpignan, France
GSK Investigational Site
Pessac, France
GSK Investigational Site
Toulon, France
GSK Investigational Site
Vandœuvre-lès-Nancy, France
GSK Investigational Site
Freiburg im Breisgau, Baden-Wurttemberg, Germany
GSK Investigational Site
Heidelberg, Baden-Wurttemberg, Germany
GSK Investigational Site
Würzburg, Bavaria, Germany
GSK Investigational Site
Offenbach, Hesse, Germany
GSK Investigational Site
Aachen, North Rhine-Westphalia, Germany
GSK Investigational Site
Dortmund, North Rhine-Westphalia, Germany
GSK Investigational Site
Mönchengladbach, North Rhine-Westphalia, Germany
GSK Investigational Site
Neuss, North Rhine-Westphalia, Germany
GSK Investigational Site
Ludwigshafen am Rhein, Rhineland-Palatinate, Germany
GSK Investigational Site
Homburg, Saarland, Germany
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