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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00426751
First received: January 24, 2007
Last updated: November 21, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention Phase
Infarction, Myocardial
Drug: Abciximab
Drug: Eptifibatide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Eptifibatide Versus Abciximab in Primary PCI for Acute ST Elevation Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Participants With Complete Sum ST Resolution (STR) 60 Minutes (Min) After Percutaneous Coronary Intervention (PCI) (Per Protocol Population) [ Time Frame: Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III) ] [ Designated as safety issue: No ]
    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).

  • Number of Participants With Complete Sum ST Resolution (STR) 60 Min After Percutaneous Coronary Intervention (PCI) (Intent-to-Treat Population) [ Time Frame: Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III) ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Number of Participants With Complete or Partial Sum ST Resolution (STR) 60 Min After PCI [ Time Frame: Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III) ] [ Designated as safety issue: No ]
    Sum STR was calculated as the difference between baseline (ECGI) and ECG III. The sum STR is the segment elevation resolution from all ECG leads associated with infarct location. ST resolution, a method used to evaluate myocardial reperfusion, was expressed as a percentage of the baseline (Complete: ≥ 70% resolution; Partial: ≥ 30% and < 70% resolution; None: < 30% resolution).

  • Number of Participants With Complete Single Lead ST Resolution (STR) 60 Min After PCI [ Time Frame: Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III) ] [ Designated as safety issue: No ]
    Single lead STR is calculated as the difference (as a percentage) between baseline (ECG I) and ECG III of either the ST elevation on one of the leads (II, III, aVF, V5, and V6) or the ST depression of one of the precordial leads (V1- V4), whichever lead showed the largest deviation either at baseline or at ECG III, respectively (Complete: ≥ 70%; Partial: ≥ 30% and <70%).

  • Mean Change From Baseline in the Sum ST Resolution 60 Min After PCI [ Time Frame: Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III) ] [ Designated as safety issue: No ]
    Sum STR was calculated as the difference between baseline (ECGI) and ECG III. The sum STR is the segment elevation resolution from all ECG leads associated with infarct location. ST resolution, a method used to evaluate myocardial reperfusion, was expressed as a percentage of the baseline.

  • Mean Change From Baseline in Single Lead ST Resolution (STR) 60 Min After PCI [ Time Frame: Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III) ] [ Designated as safety issue: No ]
    Single lead STR is calculated as the difference between baseline (ECG I) and ECG III of either the ST elevation on one of the leads (II, III, aVF, V5, and V6) or the ST depression of one of the precordial leads (V1 -V4), whichever lead showed the largest deviation either at baseline or at follow-up, respectively. STR was expressed as a percentage from baseline.

  • Mean Change From Baseline in the Sum ST Resolution (STR) Before PCI [ Time Frame: Baseline (ECG I) and immediately prior to PCI (ECG II) ] [ Designated as safety issue: No ]
    Mean sum STR was calculated as the difference between baseline (ECGI) and ECG II: the mean of the sum of ST elevation resolution from all ECG leads associated with infarct location. ST resolution was expressed as a percentage from baseline.

  • Mean Maximum ST Deviation Existing (Max STE) 60 Min After PCI [ Time Frame: 60 min +/- 15 min after PCI (ECG III) ] [ Designated as safety issue: No ]
    Max STE is measured similarly to single-lead STR, but was not compared with the ST deviation on the baseline ECG I. It was the existing ST deviation on the single ECG lead of maximum ST deviation present at 60 minutes after the PCI (ECG III).

  • Number of Participants With the Indicated Patency of Infarcted Vessels According to Thrombolysis in Myocardial Infarction (TIMI) Classification Before PCI [ Time Frame: immediately before PCI ] [ Designated as safety issue: No ]
    Number of participants with the respective patency of the infarcted vessels was evaluated by TIMI (Thrombolysis In Myocardial Infarction) flow grades (Grade 0 = No perfusion, Grade 1 = Penetration with minimal perfusion, Grade 2 = Partial perfusion, Grade 3 = Complete perfusion), as assessed by core angiography lab.

  • Number of Participants With TIMI 3 Patency of Infarcted Vessels Following PCI [ Time Frame: after PCI ] [ Designated as safety issue: No ]
    The number of participants with TIMI grade 3 (complete perfusion) patency of the infarcted vessels following PCI, as assessed by core angiography lab, was measured.

  • Mean Number of Corrected TIMI Frame Counts (cTIMI) Following PCI [ Time Frame: after PCI ] [ Designated as safety issue: No ]
    cTIMI frame counts (number of cineframes needed for dye to reach standardized distal landmarks in a coronary vessel; objective index of coronary blood flow) following PCI, as assessed by core angiography lab.

  • Number of Participants With the Indicated Myocardial Blush Grade (TIMI Myocardial Perfusion Grade [TMPG]) After PCI [ Time Frame: after PCI ] [ Designated as safety issue: No ]
    The number of participants with the indicated myocardial blush grade (TMPG), used to assess the myocardial reperfusion in the infarcted myocardium following PCI (as assessed by the core angiography laboratory), was measured. Blush grades: 0 = failure of dye to enter the microvasculature; 1 = dye slowly enters but fails to exit the microvasculature; 2 = delayed entry and exit of dye from the microvasculature; 3: normal entry and exit of dye from the microvasculature. Blush that is of only mild intensity throughout the washout phase but fades minimally is also classified as grade 3.

  • Combined Endpoint: Number of Participants With Events of Death, Re-myocardial Infarction (MI), and Urgent Target Vessel Revascularisation (UTVR) [ Time Frame: Day 7 or hospital discharge; Day 30 after index-MI ] [ Designated as safety issue: No ]
    The number of participants who died, experienced re-MI, or experienced UTVR (necessity of re-PCI of the target vessel or coronary artery bypass graft [CABG] because of recurrent ischaemic angina within 30 days after PCI) within the specified timeframe was measured.

  • Number of Participants Who Died, and/or Experienced Re-MI and UTVR (Individually Counted) [ Time Frame: Day 7 or hospital discharge; Day 30 after index-MI ] [ Designated as safety issue: No ]
    The number of participants who died, and/or experienced re-MI or UTVR (individually counted) within the specified timeframe was measured.

  • Number of Participants Who Experienced Stroke or Major Bleeding Complications [ Time Frame: Day 7 or hospital discharge; Day 30 after index-MI ] [ Designated as safety issue: No ]
    Number of participants who experienced stroke (hemorrhagic, non-hemorrhagic) or major bleedings (TIMI class: intracranial haemorrhage, spontaneous bleeding, bleeding at any instrumented site, retroperitoneal bleeding, or clinically significant overt haemorrhage associated with a drop in haematocrit of ≥ 15% or a drop in haemoglobin of ≥ 5 g/dL).

  • Number of Participants Who Died and or Experienced Re-MI Until 6 Months After PCI [ Time Frame: until 6 Month (Day 180) after index-MI ] [ Designated as safety issue: No ]
    The number of participants who died and/or experienced re-MI within 6 month after PCI was measured.

  • Number of Participants With Heart Failure Until 6 Months After PCI [ Time Frame: until 6 Months (Day 180) after index-MI ] [ Designated as safety issue: No ]
    The number of participants with heart failure within 6 month after PCI was measured.

  • Number of Participants With Major Bleedings (TIMI Classification) [ Time Frame: Day 7 or hospital discharge; Day 30 after index-MI ] [ Designated as safety issue: No ]
    Number of participants with major bleedings (according to TIMI classification: intracranial haemorrhage, spontaneous bleeding, bleeding at any instrumented site, retroperitoneal bleeding, or clinically significant overt haemorrhage associated with a drop in haematocrit of ≥ 15% or a drop in haemoglobin of ≥ 5 g/dL) within the specified timeframe was measured.

  • Number of Participants With Minor Bleedings (TIMI Classification) [ Time Frame: Day 7 or hospital discharge; Day 30 after index-MI ] [ Designated as safety issue: No ]
    The number of participants with minor bleedings (according to TIMI classification: clinically overt bleeding [e.g., gross haematuria or haematemesis) associated with a drop in haematocrit of ≥ 9% or a drop in haemoglobin of ≥ 3 g/dL) within the specified timeframe was measured.

  • Mean Duration of Stay in the Ward [ Time Frame: until 6 months after index-MI ] [ Designated as safety issue: No ]
    Costs were measured as the duration of stay in the ward (outpatient, normal ward, and intensive care unit) within the specified timeframe was measured.


Enrollment: 429
Study Start Date: October 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Abciximab
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
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.
Experimental: Eptifibatide
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
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.
Other Names:
  • Abciximab
  • Eptifibatide

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00426751

Locations
France
GSK Investigational Site
Alençon, France, 61014
GSK Investigational Site
Bordeaux, France, 33076
GSK Investigational Site
Caen Cedex 5, France, 14033
GSK Investigational Site
Créteil, France, 94010
GSK Investigational Site
Lille, France, 59037
GSK Investigational Site
Melun, France, 77000
GSK Investigational Site
Melun, France, 77007
GSK Investigational Site
Nancy, France, 54000
GSK Investigational Site
Ollioules, France, 83190
GSK Investigational Site
Pau, France, 64046
GSK Investigational Site
Perpignan, France, 66000
GSK Investigational Site
Pessac Cedex, France, 33604
GSK Investigational Site
Toulon, France, 83056
GSK Investigational Site
Vandoeuvre Les Nancy, France, 54511
Germany
GSK Investigational Site
Freiburg, Baden-Wuerttemberg, Germany, 79106
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69120
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97080
GSK Investigational Site
Offenbach, Hessen, Germany, 63069
GSK Investigational Site
Aachen, Nordrhein-Westfalen, Germany, 52074
GSK Investigational Site
Dortmund, Nordrhein-Westfalen, Germany, 44137
GSK Investigational Site
Moenchengladbach, Nordrhein-Westfalen, Germany, 41063
GSK Investigational Site
Neuss, Nordrhein-Westfalen, Germany, 41464
GSK Investigational Site
Ludwigshafen, Rheinland-Pfalz, Germany, 67063
GSK Investigational Site
Homburg, Saarland, Germany, 66421
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00426751     History of Changes
Other Study ID Numbers: 106915
Study First Received: January 24, 2007
Results First Received: April 6, 2010
Last Updated: November 21, 2012
Health Authority: Germany: German Institute of Medical Documentation and Information

Keywords provided by GlaxoSmithKline:
Eptifibatide
ST-elevation Myocardial Infarction
STEMI
Abciximab

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases
Abciximab
Eptifibatide
Anticoagulants
Hematologic Agents
Pharmacologic Actions
Platelet Aggregation Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014