Efficacy Of Eptifibatide Compared To Abciximab In Primary Percutaneous Coronary Intervention (PCI) For Acute ST Elevation Myocardial Infarction (STEMI)

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Infarction, Myocardial

Treatments: Drug: Abciximab; Drug: Eptifibatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00426751

106915

Details and patient eligibility

About

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

Enrollment: 429 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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429 participants in 2 patient groups

Abciximab

Active Comparator group

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.

Treatment:

Drug: Abciximab

Eptifibatide

Experimental group

Description:

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.

Treatment:

Drug: Eptifibatide