Abciximab
DrugIntravenous 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.
NCT Number: NCT00426751
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
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Notify Me18 year and older
All sexes
Interventional
Phase 3
GSK Investigational Site, Alençon, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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
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).
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).
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).
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%).
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.
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.
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.
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).
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.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: until 6 Months (Day 180) after index-MI
The number of participants with heart failure within 6 month after PCI was measured.
Time frame: 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.
Time frame: 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.
Time frame: 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.
GlaxoSmithKline
Industry
Eptifibatide Versus Abciximab in Primary PCI for Acute ST Elevation Myocardial Infarction
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