Clinical trial NCT00426751: Efficacy Of Eptifibatide Compared To Abciximab In Primary Percutaneous Coronary Intervention (PCI) For Acute ST Elevation Myocardial Infarction (STEMI)
Official title: Eptifibatide Versus Abciximab in Primary PCI for Acute ST Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infarction, Myocardial
Keywords: Eptifibatide
ST-elevation Myocardial Infarction
STEMI
Abciximab
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-01-25
Enrollment: 429
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Number of Participants With Complete Sum ST Resolution (STR) 60 Minutes (Min) After Percutaneous Coronary Intervention (PCI) (Per Protocol Population)
timeFrame: Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)
measure: Number of Participants With Complete Sum ST Resolution (STR) 60 Min After Percutaneous Coronary Intervention (PCI) (Intent-to-Treat Population)
timeFrame: Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)
Secondary outcomes:
measure: Number of Participants With Complete or Partial Sum ST Resolution (STR) 60 Min After PCI
timeFrame: Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)
measure: Number of Participants With Complete Single Lead ST Resolution (STR) 60 Min After PCI
timeFrame: Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)
measure: Mean Change From Baseline in the Sum ST Resolution 60 Min After PCI
timeFrame: Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)
measure: Mean Change From Baseline in Single Lead ST Resolution (STR) 60 Min After PCI
timeFrame: Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)
measure: Mean Change From Baseline in the Sum ST Resolution (STR) Before PCI
timeFrame: Baseline (ECG I) and immediately prior to PCI (ECG II)
measure: Mean Maximum ST Deviation Existing (Max STE) 60 Min After PCI
timeFrame: 60 min +/- 15 min after PCI (ECG III)
measure: Number of Participants With the Indicated Patency of Infarcted Vessels According to Thrombolysis in Myocardial Infarction (TIMI) Classification Before PCI
timeFrame: immediately before PCI
measure: Number of Participants With TIMI 3 Patency of Infarcted Vessels Following PCI
timeFrame: after PCI
measure: Mean Number of Corrected TIMI Frame Counts (cTIMI) Following PCI
timeFrame: after PCI
measure: Number of Participants With the Indicated Myocardial Blush Grade (TIMI Myocardial Perfusion Grade [TMPG]) After PCI
timeFrame: after PCI
measure: Combined Endpoint: Number of Participants With Events of Death, Re-myocardial Infarction (MI), and Urgent Target Vessel Revascularisation (UTVR)
timeFrame: Day 7 or hospital discharge; Day 30 after index-MI
measure: Number of Participants Who Died, and/or Experienced Re-MI and UTVR (Individually Counted)
timeFrame: Day 7 or hospital discharge; Day 30 after index-MI
measure: Number of Participants Who Experienced Stroke or Major Bleeding Complications
timeFrame: Day 7 or hospital discharge; Day 30 after index-MI
measure: Number of Participants Who Died and or Experienced Re-MI Until 6 Months After PCI
timeFrame: until 6 Month (Day 180) after index-MI
measure: Number of Participants With Heart Failure Until 6 Months After PCI
timeFrame: until 6 Months (Day 180) after index-MI
measure: Number of Participants With Major Bleedings (TIMI Classification)
timeFrame: Day 7 or hospital discharge; Day 30 after index-MI
measure: Number of Participants With Minor Bleedings (TIMI Classification)
timeFrame: Day 7 or hospital discharge; Day 30 after index-MI
measure: Mean Duration of Stay in the Ward
timeFrame: until 6 months after index-MI
Other outcomes:
Locations:
city: Alençon
country: France
facility: GSK Investigational Site
city: Bordeaux
country: France
facility: GSK Investigational Site
city: Caen Cedex 5
country: France
facility: GSK Investigational Site
city: Créteil
country: France
facility: GSK Investigational Site
city: Lille
country: France
facility: GSK Investigational Site
city: Melun
country: France
facility: GSK Investigational Site
city: Melun
country: France
facility: GSK Investigational Site
city: Nancy
country: France
facility: GSK Investigational Site
city: Ollioules
country: France
facility: GSK Investigational Site
city: Pau
country: France
facility: GSK Investigational Site
city: Perpignan
country: France
facility: GSK Investigational Site
city: Pessac Cedex
country: France
facility: GSK Investigational Site
city: Toulon
country: France
facility: GSK Investigational Site
city: Vandoeuvre Les Nancy
country: France
facility: GSK Investigational Site
city: Freiburg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Heidelberg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Wuerzburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Offenbach
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Aachen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Dortmund
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Moenchengladbach
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Neuss
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Ludwigshafen
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Homburg
country: Germany
facility: GSK Investigational Site
state: Saarland
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Zeymer U, Margenet A, Haude M, Bode C, Lablanche JM, Heuer H, Schroder R, Kropff S, Bourkaib R, Banik N, Zahn R, Teiger E. Randomized comparison of eptifibatide versus abciximab in primary percutaneous coronary intervention in patients with acute ST-segment elevation myocardial infarction: results of the EVA-AMI Trial. J Am Coll Cardiol. 2010 Aug 3;56(6):463-9. doi: 10.1016/j.jacc.2009.08.093.