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

NCT00426751 | Completed Phase 3 Results

• 1 other identifier: 106915
• Study Type: interventional
• Target: 429
• Locations: 2 countries
• Sites: 24

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

Conditions

Infarction, Myocardial

Keywords

Eptifibatide; ST-elevation Myocardial Infarction; STEMI; Abciximab

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)

Secondary Outcomes (18)

• Number of Participants With Complete or Partial Sum ST Resolution (STR) 60 Min After PCI

  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

  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

  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

  Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)

• Mean Change From Baseline in the Sum ST Resolution (STR) Before PCI

  Baseline (ECG I) and immediately prior to PCI (ECG II)

Study Arms (2)

Abciximab

ACTIVE COMPARATOR

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

Eptifibatide

EXPERIMENTAL

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

Interventions

Abciximab DRUG

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.

Abciximab

Eptifibatide DRUG

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

Eptifibatide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Angina or equivalent symptoms \> 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

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (24)

GSK Investigational Site

Alençon, 61014, France

Location

GSK Investigational Site

Bordeaux, 33076, France

Location

GSK Investigational Site

Caen, 14033, France

Location

GSK Investigational Site

Créteil, 94010, France

Location

GSK Investigational Site

Lille, 59037, France

Location

GSK Investigational Site

Melun, 77000, France

Location

GSK Investigational Site

Melun, 77007, France

Location

GSK Investigational Site

Nancy, 54000, France

Location

GSK Investigational Site

Ollioules, 83190, France

Location

GSK Investigational Site

Pau, 64046, France

Location

GSK Investigational Site

Perpignan, 66000, France

Location

GSK Investigational Site

Pessac, 33604, France

Location

GSK Investigational Site

Toulon, 83056, France

Location

GSK Investigational Site

Vandœuvre-lès-Nancy, 54511, France

Location

GSK Investigational Site

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

GSK Investigational Site

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

GSK Investigational Site

Würzburg, Bavaria, 97080, Germany

Location

GSK Investigational Site

Offenbach, Hesse, 63069, Germany

Location

GSK Investigational Site

Aachen, North Rhine-Westphalia, 52074, Germany

Location

GSK Investigational Site

Dortmund, North Rhine-Westphalia, 44137, Germany

Location

GSK Investigational Site

Mönchengladbach, North Rhine-Westphalia, 41063, Germany

Location

GSK Investigational Site

Neuss, North Rhine-Westphalia, 41464, Germany

Location

GSK Investigational Site

Ludwigshafen am Rhein, Rhineland-Palatinate, 67063, Germany

Location

GSK Investigational Site

Homburg, Saarland, 66421, Germany

Location

Related Publications (1)

• 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.

  PMID: 20670755 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; ST Elevation Myocardial Infarction

Interventions

Abciximab; Eptifibatide

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Peptides, Cyclic

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2007
• First Posted: January 25, 2007
• Study Start: October 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: November 27, 2012
• Results First Posted: April 26, 2010

Record last verified: 2012-11

Locations

DE (10); FR (14)