Infarction, Myocardial
Conditions
Keywords
Eptifibatide, ST-elevation Myocardial Infarction, STEMI, Abciximab
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
Interventions
DRUGAbciximab
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.
DRUGEptifibatide
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.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Complete Sum ST Resolution (STR) 60 Minutes (Min) After Percutaneous Coronary Intervention (PCI) (Per Protocol Population) | 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) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in the Sum ST Resolution 60 Min After PCI | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
| Number of Participants With Complete or Partial Sum ST Resolution (STR) 60 Min After PCI | 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 Who Died, and/or Experienced Re-MI and UTVR (Individually Counted) | 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. |
| Number of Participants Who Experienced Stroke or Major Bleeding Complications | 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). |
| Number of Participants Who Died and or Experienced Re-MI Until 6 Months After PCI | 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. |
| Number of Participants With Heart Failure Until 6 Months After PCI | until 6 Months (Day 180) after index-MI | The number of participants with heart failure within 6 month after PCI was measured. |
| Number of Participants With Major Bleedings (TIMI Classification) | 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. |
| Number of Participants With Minor Bleedings (TIMI Classification) | 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. |
| Mean Duration of Stay in the Ward | 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. |
| Combined Endpoint: Number of Participants With Events of Death, Re-myocardial Infarction (MI), and Urgent Target Vessel Revascularisation (UTVR) | 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. |
| Number of Participants With Complete Single Lead ST Resolution (STR) 60 Min After PCI | 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%). |
Countries
France, Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 214 |
| 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 | 196 |
| Total | 410 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 8 | 1 |
| Overall Study | Consent Withdrawn | 0 | 1 |
| Overall Study | Lost to Follow-up | 7 | 6 |
| Overall Study | Other Reasons | 7 | 12 |
Baseline characteristics
| Characteristic | Eptifibatide | Abciximab | Total |
|---|---|---|---|
| Age Continuous | 61.3 years STANDARD_DEVIATION 12.5 | 60.5 years STANDARD_DEVIATION 12.7 | 60.9 years STANDARD_DEVIATION 12.6 |
| Sex: Female, Male Female | 50 Participants | 39 Participants | 89 Participants |
| Sex: Female, Male Male | 164 Participants | 157 Participants | 321 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 49 / 226 | 28 / 201 |
| serious Total, serious adverse events | 24 / 226 | 19 / 201 |
Outcome results
Primary
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).
Time frame: Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)
Population: Intent-to-Treat (ITT) Population: All randomized participants who received at least one dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eptifibatide | Number of Participants With Complete Sum ST Resolution (STR) 60 Min After Percutaneous Coronary Intervention (PCI) (Intent-to-Treat Population) | 124 participants |
| Abciximab | Number of Participants With Complete Sum ST Resolution (STR) 60 Min After Percutaneous Coronary Intervention (PCI) (Intent-to-Treat Population) | 103 participants |
95% CI: [-3, 16.6]
Primary
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).
Time frame: Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)
Population: Per Protocol (PP) Population: All randomized participants who received at least one dose of study drug, who had data that were fully evaluable for the primary endpoint, and who did not show any major protocol violation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eptifibatide | Number of Participants With Complete Sum ST Resolution (STR) 60 Minutes (Min) After Percutaneous Coronary Intervention (PCI) (Per Protocol Population) | 71 participants |
| Abciximab | Number of Participants With Complete Sum ST Resolution (STR) 60 Minutes (Min) After Percutaneous Coronary Intervention (PCI) (Per Protocol Population) | 65 participants |
90% CI: [-8.5, 12.8]
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.
Time frame: Day 7 or hospital discharge; Day 30 after index-MI
Population: Safety Population: All participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eptifibatide | Combined Endpoint: Number of Participants With Events of Death, Re-myocardial Infarction (MI), and Urgent Target Vessel Revascularisation (UTVR) | Death, re-MI, or UTVR until day 7 or discharge | 12 participants |
| Eptifibatide | Combined Endpoint: Number of Participants With Events of Death, Re-myocardial Infarction (MI), and Urgent Target Vessel Revascularisation (UTVR) | Death, re-MI, or UTVR until day 30 | 17 participants |
| Abciximab | Combined Endpoint: Number of Participants With Events of Death, Re-myocardial Infarction (MI), and Urgent Target Vessel Revascularisation (UTVR) | Death, re-MI, or UTVR until day 7 or discharge | 14 participants |
| Abciximab | Combined Endpoint: Number of Participants With Events of Death, Re-myocardial Infarction (MI), and Urgent Target Vessel Revascularisation (UTVR) | Death, re-MI, or UTVR until day 30 | 17 participants |
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.
Time frame: Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)
Population: ITT Population. Participants with unevaluable ECGs were excluded from analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eptifibatide | Mean Change From Baseline in Single Lead ST Resolution (STR) 60 Min After PCI | 70.2 percent change | Standard Deviation 25.5 |
| Abciximab | Mean Change From Baseline in Single Lead ST Resolution (STR) 60 Min After PCI | 64.0 percent change | Standard Deviation 28.7 |
Secondary
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.
Time frame: Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eptifibatide | Mean Change From Baseline in the Sum ST Resolution 60 Min After PCI | 71.6 percent change | Standard Deviation 27.2 |
| Abciximab | Mean Change From Baseline in the Sum ST Resolution 60 Min After PCI | 66.3 percent change | Standard Deviation 31.1 |
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.
Time frame: Baseline (ECG I) and immediately prior to PCI (ECG II)
Population: ITT Population. Participants who did not have an ECG II immediately before PCI were excluded from analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eptifibatide | Mean Change From Baseline in the Sum ST Resolution (STR) Before PCI | 25.9 percent change | Standard Deviation 32 |
| Abciximab | Mean Change From Baseline in the Sum ST Resolution (STR) Before PCI | 21.2 percent change | Standard Deviation 29 |
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.
Time frame: until 6 months after index-MI
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eptifibatide | Mean Duration of Stay in the Ward | 8.0 days | Standard Deviation 6.7 |
| Abciximab | Mean Duration of Stay in the Ward | 9.7 days | Standard Deviation 11.9 |
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).
Time frame: 60 min +/- 15 min after PCI (ECG III)
Population: ITT Population. Participants with unevaluable ECGs were excluded from analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eptifibatide | Mean Maximum ST Deviation Existing (Max STE) 60 Min After PCI | 1.1 millimeters (mm) | Standard Deviation 1.1 |
| Abciximab | Mean Maximum ST Deviation Existing (Max STE) 60 Min After PCI | 1.4 millimeters (mm) | Standard Deviation 1.4 |
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.
Time frame: after PCI
Population: ITT Population. Participants with un-evaluable angiographies were excluded from analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eptifibatide | Mean Number of Corrected TIMI Frame Counts (cTIMI) Following PCI | 25.3 number of frame counts | Standard Deviation 21 |
| Abciximab | Mean Number of Corrected TIMI Frame Counts (cTIMI) Following PCI | 23.6 number of frame counts | Standard Deviation 17.9 |
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.
Time frame: Day 7 or hospital discharge; Day 30 after index-MI
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eptifibatide | Number of Participants Who Died, and/or Experienced Re-MI and UTVR (Individually Counted) | Deaths until day 7 or discharge | 8 participants |
| Eptifibatide | Number of Participants Who Died, and/or Experienced Re-MI and UTVR (Individually Counted) | Deaths until day 30 | 13 participants |
| Eptifibatide | Number of Participants Who Died, and/or Experienced Re-MI and UTVR (Individually Counted) | Re-MI until day 7 or discharge | 0 participants |
| Eptifibatide | Number of Participants Who Died, and/or Experienced Re-MI and UTVR (Individually Counted) | Re-MI until day 30 | 0 participants |
| Eptifibatide | Number of Participants Who Died, and/or Experienced Re-MI and UTVR (Individually Counted) | UTVR until day 7 or discharge | 5 participants |
| Eptifibatide | Number of Participants Who Died, and/or Experienced Re-MI and UTVR (Individually Counted) | UTVR until day 30 | 5 participants |
| Abciximab | Number of Participants Who Died, and/or Experienced Re-MI and UTVR (Individually Counted) | UTVR until day 7 or discharge | 8 participants |
| Abciximab | Number of Participants Who Died, and/or Experienced Re-MI and UTVR (Individually Counted) | Deaths until day 7 or discharge | 7 participants |
| Abciximab | Number of Participants Who Died, and/or Experienced Re-MI and UTVR (Individually Counted) | Re-MI until day 30 | 5 participants |
| Abciximab | Number of Participants Who Died, and/or Experienced Re-MI and UTVR (Individually Counted) | Deaths until day 30 | 7 participants |
| Abciximab | Number of Participants Who Died, and/or Experienced Re-MI and UTVR (Individually Counted) | UTVR until day 30 | 10 participants |
| Abciximab | Number of Participants Who Died, and/or Experienced Re-MI and UTVR (Individually Counted) | Re-MI until day 7 or discharge | 3 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.
Time frame: until 6 Month (Day 180) after index-MI
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eptifibatide | Number of Participants Who Died and or Experienced Re-MI Until 6 Months After PCI | 15 participants |
| Abciximab | Number of Participants Who Died and or Experienced Re-MI Until 6 Months After PCI | 15 participants |
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).
Time frame: Day 7 or hospital discharge; Day 30 after index-MI
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eptifibatide | Number of Participants Who Experienced Stroke or Major Bleeding Complications | Stroke or major bleeding until day 7 or discharge | 6 participants |
| Eptifibatide | Number of Participants Who Experienced Stroke or Major Bleeding Complications | Stroke or major bleeding until day 30 | 6 participants |
| Abciximab | Number of Participants Who Experienced Stroke or Major Bleeding Complications | Stroke or major bleeding until day 7 or discharge | 1 participants |
| Abciximab | Number of Participants Who Experienced Stroke or Major Bleeding Complications | Stroke or major bleeding until day 30 | 2 participants |
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).
Time frame: Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eptifibatide | Number of Participants With Complete or Partial Sum ST Resolution (STR) 60 Min After PCI | Complete sum STR( ≥70%) | 124 participants |
| Eptifibatide | Number of Participants With Complete or Partial Sum ST Resolution (STR) 60 Min After PCI | Complete or partial sum STR (≥30%) | 180 participants |
| Eptifibatide | Number of Participants With Complete or Partial Sum ST Resolution (STR) 60 Min After PCI | Partial sum STR (≥30% and <70%) | 56 participants |
| Eptifibatide | Number of Participants With Complete or Partial Sum ST Resolution (STR) 60 Min After PCI | No sum STR (<30%) | 34 participants |
| Abciximab | Number of Participants With Complete or Partial Sum ST Resolution (STR) 60 Min After PCI | No sum STR (<30%) | 42 participants |
| Abciximab | Number of Participants With Complete or Partial Sum ST Resolution (STR) 60 Min After PCI | Complete sum STR( ≥70%) | 103 participants |
| Abciximab | Number of Participants With Complete or Partial Sum ST Resolution (STR) 60 Min After PCI | Partial sum STR (≥30% and <70%) | 51 participants |
| Abciximab | Number of Participants With Complete or Partial Sum ST Resolution (STR) 60 Min After PCI | Complete or partial sum STR (≥30%) | 154 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%).
Time frame: Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eptifibatide | Number of Participants With Complete Single Lead ST Resolution (STR) 60 Min After PCI | 105 participants |
| Abciximab | Number of Participants With Complete Single Lead ST Resolution (STR) 60 Min After PCI | 82 participants |
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.
Time frame: until 6 Months (Day 180) after index-MI
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eptifibatide | Number of Participants With Heart Failure Until 6 Months After PCI | 23 participants |
| Abciximab | Number of Participants With Heart Failure Until 6 Months After PCI | 22 participants |
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.
Time frame: Day 7 or hospital discharge; Day 30 after index-MI
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eptifibatide | Number of Participants With Major Bleedings (TIMI Classification) | Major bleedings (TIMI classification) until day 7 | 6 participants |
| Eptifibatide | Number of Participants With Major Bleedings (TIMI Classification) | Major bleedings (TIMI classification) until day 30 | 6 participants |
| Abciximab | Number of Participants With Major Bleedings (TIMI Classification) | Major bleedings (TIMI classification) until day 7 | 0 participants |
| Abciximab | Number of Participants With Major Bleedings (TIMI Classification) | Major bleedings (TIMI classification) until day 30 | 1 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.
Time frame: Day 7 or hospital discharge; Day 30 after index-MI
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eptifibatide | Number of Participants With Minor Bleedings (TIMI Classification) | Minor bleedings (TIMI classification) until day 30 | 19 participants |
| Eptifibatide | Number of Participants With Minor Bleedings (TIMI Classification) | Minor bleedings (TIMI classification) until day 7 | 19 participants |
| Abciximab | Number of Participants With Minor Bleedings (TIMI Classification) | Minor bleedings (TIMI classification) until day 7 | 12 participants |
| Abciximab | Number of Participants With Minor Bleedings (TIMI Classification) | Minor bleedings (TIMI classification) until day 30 | 12 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.
Time frame: after PCI
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eptifibatide | Number of Participants With the Indicated Myocardial Blush Grade (TIMI Myocardial Perfusion Grade [TMPG]) After PCI | Myocardial blush Grade 2 | 0 participants |
| Eptifibatide | Number of Participants With the Indicated Myocardial Blush Grade (TIMI Myocardial Perfusion Grade [TMPG]) After PCI | Myocardial blush Grade 0 | 13 participants |
| Eptifibatide | Number of Participants With the Indicated Myocardial Blush Grade (TIMI Myocardial Perfusion Grade [TMPG]) After PCI | Myocardial blush Grade 1 | 98 participants |
| Eptifibatide | Number of Participants With the Indicated Myocardial Blush Grade (TIMI Myocardial Perfusion Grade [TMPG]) After PCI | Not assessable | 38 participants |
| Eptifibatide | Number of Participants With the Indicated Myocardial Blush Grade (TIMI Myocardial Perfusion Grade [TMPG]) After PCI | Myocardial blush Grade 3 | 64 participants |
| Abciximab | Number of Participants With the Indicated Myocardial Blush Grade (TIMI Myocardial Perfusion Grade [TMPG]) After PCI | Not assessable | 34 participants |
| Abciximab | Number of Participants With the Indicated Myocardial Blush Grade (TIMI Myocardial Perfusion Grade [TMPG]) After PCI | Myocardial blush Grade 3 | 54 participants |
| Abciximab | Number of Participants With the Indicated Myocardial Blush Grade (TIMI Myocardial Perfusion Grade [TMPG]) After PCI | Myocardial blush Grade 2 | 0 participants |
| Abciximab | Number of Participants With the Indicated Myocardial Blush Grade (TIMI Myocardial Perfusion Grade [TMPG]) After PCI | Myocardial blush Grade 1 | 96 participants |
| Abciximab | Number of Participants With the Indicated Myocardial Blush Grade (TIMI Myocardial Perfusion Grade [TMPG]) After PCI | Myocardial blush Grade 0 | 11 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.
Time frame: immediately before PCI
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eptifibatide | Number of Participants With the Indicated Patency of Infarcted Vessels According to Thrombolysis in Myocardial Infarction (TIMI) Classification Before PCI | TIMI 3 patency before PCI | 74 participants |
| Eptifibatide | Number of Participants With the Indicated Patency of Infarcted Vessels According to Thrombolysis in Myocardial Infarction (TIMI) Classification Before PCI | TIMI 2/3 patency before PCI | 85 participants |
| Eptifibatide | Number of Participants With the Indicated Patency of Infarcted Vessels According to Thrombolysis in Myocardial Infarction (TIMI) Classification Before PCI | TIMI 0/1 patency before PCI | 117 participants |
| Abciximab | Number of Participants With the Indicated Patency of Infarcted Vessels According to Thrombolysis in Myocardial Infarction (TIMI) Classification Before PCI | TIMI 3 patency before PCI | 59 participants |
| Abciximab | Number of Participants With the Indicated Patency of Infarcted Vessels According to Thrombolysis in Myocardial Infarction (TIMI) Classification Before PCI | TIMI 2/3 patency before PCI | 67 participants |
| Abciximab | Number of Participants With the Indicated Patency of Infarcted Vessels According to Thrombolysis in Myocardial Infarction (TIMI) Classification Before PCI | TIMI 0/1 patency before PCI | 123 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.
Time frame: after PCI
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eptifibatide | Number of Participants With TIMI 3 Patency of Infarcted Vessels Following PCI | 145 participants |
| Abciximab | Number of Participants With TIMI 3 Patency of Infarcted Vessels Following PCI | 137 participants |