Efficacy Of Eptifibatide Compared To Abciximab In Primary Percutaneous Coronary Intervention (PCI) For Acute ST Elevation Myocardial Infarction (STEMI)
Condition: Infarction, Myocardial
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Intervention: Abciximab; Eptifibatide
Intervention description: 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.
Intervention MeSH terms: Abciximab; Eptifibatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 429.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Eptifibatide; ST-elevation Myocardial Infarction; STEMI; Abciximab

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 < 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.