Phase 3
N=429
Efficacy Of Eptifibatide Compared To Abciximab In Primary Percutaneous Coronary Intervention (PCI) For Acute ST Elevation Myocardial Infarction (STEMI)
Infarction, Myocardial
Bottom Line
View on ClinicalTrials.gov: NCT00426751 ↗Enrolled (actual)
429
Serious AEs
10.1%
Results posted
Apr 2010
Primary outcome: Primary: Number of Participants With Complete Sum ST Resolution (STR) 60 Minutes (Min) After Percutaneous Coronary Intervention (PCI) (Per Protocol Population) — 71; 65 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Abciximab (Drug); Eptifibatide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Dec 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Complete Sum ST Resolution (STR) 60 Minutes (Min) After Percutaneous Coronary Intervention (PCI) (Per Protocol Population) |
71; 65 | — |
| PRIMARY Number of Participants With Complete Sum ST Resolution (STR) 60 Min After Percutaneous Coronary Intervention (PCI) (Intent-to-Treat Population) |
124; 103 | — |
| SECONDARY Number of Participants With Complete or Partial Sum ST Resolution (STR) 60 Min After PCI |
124; 103; 180; 154; 56; 51 | — |
| SECONDARY Number of Participants With Complete Single Lead ST Resolution (STR) 60 Min After PCI |
105; 82 | — |
| SECONDARY Mean Change From Baseline in the Sum ST Resolution 60 Min After PCI |
71.6; 66.3 | — |
| SECONDARY Mean Change From Baseline in Single Lead ST Resolution (STR) 60 Min After PCI |
70.2; 64.0 | — |
| SECONDARY Mean Change From Baseline in the Sum ST Resolution (STR) Before PCI |
25.9; 21.2 | — |
| SECONDARY Mean Maximum ST Deviation Existing (Max STE) 60 Min After PCI |
1.1; 1.4 | — |
| SECONDARY Number of Participants With the Indicated Patency of Infarcted Vessels According to Thrombolysis in Myocardial Infarction (TIMI) Classification Before PCI |
74; 59; 85; 67; 117; 123 | — |
| SECONDARY Number of Participants With TIMI 3 Patency of Infarcted Vessels Following PCI |
145; 137 | — |
| SECONDARY Mean Number of Corrected TIMI Frame Counts (cTIMI) Following PCI |
25.3; 23.6 | — |
| SECONDARY Number of Participants With the Indicated Myocardial Blush Grade (TIMI Myocardial Perfusion Grade [TMPG]) After PCI |
64; 54; 0; 0; 98; 96 | — |
| SECONDARY Combined Endpoint: Number of Participants With Events of Death, Re-myocardial Infarction (MI), and Urgent Target Vessel Revascularisation (UTVR) |
12; 14; 17; 17 | — |
| SECONDARY Number of Participants Who Died, and/or Experienced Re-MI and UTVR (Individually Counted) |
8; 7; 13; 7; 0; 3 | — |
| SECONDARY Number of Participants Who Experienced Stroke or Major Bleeding Complications |
6; 1; 6; 2 | — |
| SECONDARY Number of Participants Who Died and or Experienced Re-MI Until 6 Months After PCI |
15; 15 | — |
| SECONDARY Number of Participants With Heart Failure Until 6 Months After PCI |
23; 22 | — |
| SECONDARY Number of Participants With Major Bleedings (TIMI Classification) |
6; 0; 6; 1 | — |
| SECONDARY Number of Participants With Minor Bleedings (TIMI Classification) |
19; 12; 19; 12 | — |
| SECONDARY Mean Duration of Stay in the Ward |
8.0; 9.7 | — |
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
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 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.
Data sourced from ClinicalTrials.gov (NCT00426751). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.