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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

429 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infarction, Myocardial

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Eptifibatide ST-elevation Myocardial Infarction STEMI Abciximab

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Abciximab

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Eptifibatide

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Abciximab

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED

PMID: 20670755 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

106915

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Abciximab

Abciximab

Eptifibatide

Eptifibatide

Interventions

Abciximab

Eptifibatide

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

GlaxoSmithKline

Responsible Party

Principal Investigators

GSK Clinical Trials

Locations

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

Countries

References

Other Identifiers

106915