A Phase 3 interventional study of Abciximab and Eptifibatide in Infarction, Myocardial, sponsored by GlaxoSmithKline. Completed at 24 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-11-27.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment
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
2,779 studies on the registry are indexed under Myocardial Infarction; 417 are open to participants now.
This study's enrollment of 429 is above the median of 148 across 1,613 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Acute myocardial infarction \< 12 h defined as:
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.
Drug: Abciximab
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.
Drug: Eptifibatide
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.
Also known as: Abciximab
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)
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)
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)
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)
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)
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)
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)
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)
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
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
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
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
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
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
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
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
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
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
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
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
| Milestone | Eptifibatide | Abciximab |
|---|---|---|
| Started | 226 | 203 |
| Completed | 204 | 183 |
| Not completed | 22 | 20 |
| Withdrew: Adverse event | 8 | 1 |
| Withdrew: Lost to follow-up | 7 | 6 |
| Withdrew: Consent withdrawn | 0 | 1 |
| Withdrew: Other reasons | 7 | 12 |
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).
| participants | Eptifibatide | Abciximab |
|---|---|---|
| Number of Participants With Complete Sum ST Resolution (STR) 60 Minutes (Min) After Percutaneous Coronary Intervention (PCI) (Per Protocol Population) | 71 | 65 |
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).
| participants | Eptifibatide | Abciximab |
|---|---|---|
| Number of Participants With Complete Sum ST Resolution (STR) 60 Min After Percutaneous Coronary Intervention (PCI) (Intent-to-Treat Population) | 124 | 103 |
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).
| participants | Eptifibatide | Abciximab |
|---|---|---|
| Complete sum STR( ≥70%) | 124 | 103 |
| Complete or partial sum STR (≥30%) | 180 | 154 |
| Partial sum STR (≥30% and <70%) | 56 | 51 |
| No sum STR (<30%) | 34 | 42 |
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%).
| participants | Eptifibatide | Abciximab |
|---|---|---|
| Number of Participants With Complete Single Lead ST Resolution (STR) 60 Min After PCI | 105 | 82 |
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.
| percent change | Eptifibatide | Abciximab |
|---|---|---|
| Mean Change From Baseline in the Sum ST Resolution 60 Min After PCI | 71.6 ± 27.2 | 66.3 ± 31.1 |
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.
| percent change | Eptifibatide | Abciximab |
|---|---|---|
| Mean Change From Baseline in Single Lead ST Resolution (STR) 60 Min After PCI | 70.2 ± 25.5 | 64.0 ± 28.7 |
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.
| percent change | Eptifibatide | Abciximab |
|---|---|---|
| Mean Change From Baseline in the Sum ST Resolution (STR) Before PCI | 25.9 ± 32.0 | 21.2 ± 29.0 |
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).
| millimeters (mm) | Eptifibatide | Abciximab |
|---|---|---|
| Mean Maximum ST Deviation Existing (Max STE) 60 Min After PCI | 1.1 ± 1.1 | 1.4 ± 1.4 |
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.
| participants | Eptifibatide | Abciximab |
|---|---|---|
| TIMI 3 patency before PCI | 74 | 59 |
| TIMI 2/3 patency before PCI | 85 | 67 |
| TIMI 0/1 patency before PCI | 117 | 123 |
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.
| participants | Eptifibatide | Abciximab |
|---|---|---|
| Number of Participants With TIMI 3 Patency of Infarcted Vessels Following PCI | 145 | 137 |
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 frame counts | Eptifibatide | Abciximab |
|---|---|---|
| Mean Number of Corrected TIMI Frame Counts (cTIMI) Following PCI | 25.3 ± 21.0 | 23.6 ± 17.9 |
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.
| participants | Eptifibatide | Abciximab |
|---|---|---|
| Myocardial blush Grade 3 | 64 | 54 |
| Myocardial blush Grade 2 | 0 | 0 |
| Myocardial blush Grade 1 | 98 | 96 |
| Myocardial blush Grade 0 | 13 | 11 |
| Not assessable | 38 | 34 |
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.
| participants | Eptifibatide | Abciximab |
|---|---|---|
| Death, re-MI, or UTVR until day 7 or discharge | 12 | 14 |
| Death, re-MI, or UTVR until day 30 | 17 | 17 |
The number of participants who died, and/or experienced re-MI or UTVR (individually counted) within the specified timeframe was measured.
| participants | Eptifibatide | Abciximab |
|---|---|---|
| Deaths until day 7 or discharge | 8 | 7 |
| Deaths until day 30 | 13 | 7 |
| Re-MI until day 7 or discharge | 0 | 3 |
| Re-MI until day 30 | 0 | 5 |
| UTVR until day 7 or discharge | 5 | 8 |
| UTVR until day 30 | 5 | 10 |
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).
| participants | Eptifibatide | Abciximab |
|---|---|---|
| Stroke or major bleeding until day 7 or discharge | 6 | 1 |
| Stroke or major bleeding until day 30 | 6 | 2 |
The number of participants who died and/or experienced re-MI within 6 month after PCI was measured.
| participants | Eptifibatide | Abciximab |
|---|---|---|
| Number of Participants Who Died and or Experienced Re-MI Until 6 Months After PCI | 15 | 15 |
The number of participants with heart failure within 6 month after PCI was measured.
| participants | Eptifibatide | Abciximab |
|---|---|---|
| Number of Participants With Heart Failure Until 6 Months After PCI | 23 | 22 |
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.
| participants | Eptifibatide | Abciximab |
|---|---|---|
| Major bleedings (TIMI classification) until day 7 | 6 | 0 |
| Major bleedings (TIMI classification) until day 30 | 6 | 1 |
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.
| participants | Eptifibatide | Abciximab |
|---|---|---|
| Minor bleedings (TIMI classification) until day 7 | 19 | 12 |
| Minor bleedings (TIMI classification) until day 30 | 19 | 12 |
Costs were measured as the duration of stay in the ward (outpatient, normal ward, and intensive care unit) within the specified timeframe was measured.
| days | Eptifibatide | Abciximab |
|---|---|---|
| Mean Duration of Stay in the Ward | 8.0 ± 6.7 | 9.7 ± 11.9 |
Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Eptifibatide | — | 24/226 (10.6%) | 49/226 (21.7%) |
| Abciximab | — | 19/201 (9.5%) | 28/201 (13.9%) |
| Event | Eptifibatide | Abciximab |
|---|---|---|
| Cardiogenic shockCardiac disorders | 4/226 | 2/201 |
| Angina pectorisCardiac disorders | 2/226 | 2/201 |
| Pericardial effusionCardiac disorders | 0/226 | 2/201 |
| Cardiac failureCardiac disorders | 2/226 | 0/201 |
| Ventricular tachycardiaCardiac disorders | 2/226 | 0/201 |
| HaemorrhageVascular disorders | 2/226 | 0/201 |
| Acute myocardial infarctionCardiac disorders | 0/226 | 1/201 |
| Atrioventricular block completeCardiac disorders | 0/226 | 1/201 |
| Ventricular septal defectCongenital, familial and genetic disorders | 0/226 | 1/201 |
| MalaiseGeneral disorders | 0/226 | 1/201 |
| Event | Eptifibatide | Abciximab |
|---|---|---|
| Post procedural heamatomaInjury, poisoning and procedural complications | 12/226 | 9/201 |
| Angina pectorisCardiac disorders | 11/226 | 5/201 |
| Ventricular tachycardiaCardiac disorders | 9/226 | 6/201 |
| Ventricular extrasystolesCardiac disorders | 7/226 | 4/201 |
| Cardiac failureCardiac disorders | 5/226 | 0/201 |
| Back painMusculoskeletal and connective tissue disorders | 5/226 | 0/201 |
| HeadacheNervous system disorders | 0/226 | 4/201 |
| Age Continuous(years) | Eptifibatide | Abciximab | Total |
|---|---|---|---|
| Mean | 61.3 ± 12.5 | 60.5 ± 12.7 | 60.9 ± 12.6 |
| Sex: Female, Male(Participants) | Eptifibatide | Abciximab | Total |
|---|---|---|---|
| Female | 50 | 39 | 89 |
| Male | 164 | 157 | 321 |
This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Eptifibatide