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

November 21, 2012 updated by: GlaxoSmithKline

Eptifibatide Versus Abciximab in Primary PCI for Acute ST Elevation Myocardial Infarction

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
429

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • 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
        • GSK Investigational Site
  • Germany
    • Baden-Wuerttemberg
      • Freiburg, Baden-Wuerttemberg, Germany, 79106
        • GSK Investigational Site
      • Heidelberg, Baden-Wuerttemberg, Germany, 69120
        • GSK Investigational Site
    • Bayern
      • Wuerzburg, Bayern, Germany, 97080
        • GSK Investigational Site
    • Hessen
      • Offenbach, Hessen, Germany, 63069
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • 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
    • Rheinland-Pfalz
      • Ludwigshafen, Rheinland-Pfalz, Germany, 67063
        • GSK Investigational Site
    • Saarland
      • Homburg, Saarland, Germany, 66421
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
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)
Time Frame: Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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).
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
Time Frame: Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)
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%).
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
Time Frame: Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)
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.
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
Time Frame: Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)
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.
Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)
Mean Change From Baseline in the Sum ST Resolution (STR) Before PCI
Time Frame: Baseline (ECG I) and immediately prior to PCI (ECG II)
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.
Baseline (ECG I) and immediately prior to PCI (ECG II)
Mean Maximum ST Deviation Existing (Max STE) 60 Min After PCI
Time Frame: 60 min +/- 15 min after PCI (ECG III)
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).
60 min +/- 15 min after 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
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.
immediately before PCI
Number of Participants With TIMI 3 Patency of Infarcted Vessels Following PCI
Time Frame: after PCI
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.
after PCI
Mean Number of Corrected TIMI Frame Counts (cTIMI) Following PCI
Time Frame: after PCI
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.
after PCI
Number of Participants With the Indicated Myocardial Blush Grade (TIMI Myocardial Perfusion Grade [TMPG]) After PCI
Time Frame: after PCI
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.
after PCI
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
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.
Day 7 or hospital discharge; Day 30 after index-MI
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
The number of participants who died, and/or experienced re-MI or UTVR (individually counted) within the specified timeframe was measured.
Day 7 or hospital discharge; Day 30 after index-MI
Number of Participants Who Experienced Stroke or Major Bleeding Complications
Time Frame: Day 7 or hospital discharge; Day 30 after index-MI
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).
Day 7 or hospital discharge; Day 30 after index-MI
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
The number of participants who died and/or experienced re-MI within 6 month after PCI was measured.
until 6 Month (Day 180) after index-MI
Number of Participants With Heart Failure Until 6 Months After PCI
Time Frame: until 6 Months (Day 180) after index-MI
The number of participants with heart failure within 6 month after PCI was measured.
until 6 Months (Day 180) after index-MI
Number of Participants With Major Bleedings (TIMI Classification)
Time Frame: Day 7 or hospital discharge; Day 30 after index-MI
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.
Day 7 or hospital discharge; Day 30 after index-MI
Number of Participants With Minor Bleedings (TIMI Classification)
Time Frame: Day 7 or hospital discharge; Day 30 after index-MI
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.
Day 7 or hospital discharge; Day 30 after index-MI
Mean Duration of Stay in the Ward
Time Frame: until 6 months after index-MI
Costs were measured as the duration of stay in the ward (outpatient, normal ward, and intensive care unit) within the specified timeframe was measured.
until 6 months after index-MI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 25, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 27, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 106915

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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