Infarction, MyocardialPhase 3NCT00426751

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

A Phase 3 study testing Abciximab and Eptifibatide in people with Infarction, Myocardial, run by GlaxoSmithKline at 24 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Infarction, Myocardial
What is being tested?: Abciximab and Eptifibatide
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 429 participants
Where: 24 sitesin 2 countries
Study dates: Oct 2006to Dec 2007
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 14Show fewer

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.

Trial locations and contacts

24 sites in 2 countries.

Country

City, postcode or hospital

24 sites in 2 countries

France14 sites

GSK Investigational Site
Alençon, 61014
GSK Investigational Site
Bordeaux, 33076
GSK Investigational Site
Caen, 14033
GSK Investigational Site
Créteil, 94010
GSK Investigational Site
Lille, 59037
GSK Investigational Site
Melun, 77000
GSK Investigational Site
Melun, 77007
GSK Investigational Site
Nancy, 54000
GSK Investigational Site
Ollioules, 83190
GSK Investigational Site
Pau, 64046
GSK Investigational Site
Perpignan, 66000
GSK Investigational Site
Pessac, 33604
GSK Investigational Site
Toulon, 83056
GSK Investigational Site
Vandœuvre-lès-Nancy, 54511

Other trials in France

Germany10 sites

GSK Investigational Site
Aachen, North Rhine-Westphalia, 52074
GSK Investigational Site
Dortmund, North Rhine-Westphalia, 44137
GSK Investigational Site
Freiburg im Breisgau, Baden-Wurttemberg, 79106
GSK Investigational Site
Heidelberg, Baden-Wurttemberg, 69120
GSK Investigational Site
Homburg, Saarland, 66421
GSK Investigational Site
Ludwigshafen am Rhein, Rhineland-Palatinate, 67063
GSK Investigational Site
Mönchengladbach, North Rhine-Westphalia, 41063
GSK Investigational Site
Neuss, North Rhine-Westphalia, 41464
GSK Investigational Site
Offenbach, Hesse, 63069
GSK Investigational Site
Würzburg, Bavaria, 97080

Other trials in Germany

About this study

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

Conditions: Infarction, Myocardial
Being tested: Abciximab, Eptifibatide
Keywords: Eptifibatide, ST-elevation Myocardial Infarction, STEMI, Abciximab
Medical subject headings: Myocardial Infarction, ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AbciximabDrug
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.
EptifibatideDrug
Also called Abciximab
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.

Study groups in NCT00426751
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Eptifibatide

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 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
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).
Measured: 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
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%).
Measured: 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
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.
Measured: 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
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.
Measured: Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)
Mean Change From Baseline in the Sum ST Resolution (STR) Before PCI
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.
Measured: Baseline (ECG I) and immediately prior to PCI (ECG II)
Mean Maximum ST Deviation Existing (Max STE) 60 Min After PCI
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).
Measured: 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
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.
Measured: immediately before PCI
Number of Participants With TIMI 3 Patency of Infarcted Vessels Following 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.
Measured: after PCI
Mean Number of Corrected TIMI Frame Counts (cTIMI) Following 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.
Measured: after PCI
Number of Participants With the Indicated Myocardial Blush Grade (TIMI Myocardial Perfusion Grade [TMPG]) 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.
Measured: after PCI
Combined Endpoint: Number of Participants With Events of Death, Re-myocardial Infarction (MI), and Urgent Target Vessel Revascularisation (UTVR)
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.
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)
The number of participants who died, and/or experienced re-MI or UTVR (individually counted) within the specified timeframe was measured.
Measured: Day 7 or hospital discharge; Day 30 after index-MI
Number of Participants Who Experienced Stroke or Major Bleeding Complications
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).
Measured: 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
The number of participants who died and/or experienced re-MI within 6 month after PCI was measured.
Measured: until 6 Month (Day 180) after index-MI
Number of Participants With Heart Failure Until 6 Months After PCI
The number of participants with heart failure within 6 month after PCI was measured.
Measured: until 6 Months (Day 180) after index-MI
Number of Participants With Major Bleedings (TIMI Classification)
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.
Measured: Day 7 or hospital discharge; Day 30 after index-MI
Number of Participants With Minor Bleedings (TIMI Classification)
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.
Measured: Day 7 or hospital discharge; Day 30 after index-MI
Mean Duration of Stay in the Ward
Costs were measured as the duration of stay in the ward (outpatient, normal ward, and intensive care unit) within the specified timeframe was measured.
Measured: until 6 months after index-MI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2006Dec 2007

First posted25 Jan 2007 (estimated)
Study startOct 2006
Primary completionDec 2007
Study completionDec 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Infarction, MyocardialStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 429 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00426751
Sponsor's protocol ID: 106915
Status last verified: Nov 2012
First submitted: 24 Jan 2007
Last updated: 27 Nov 2012
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 20670755

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Infarction, Myocardial trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Eptifibatide Versus Abciximab in Primary PCI for Acute ST Elevation Myocardial Infarction
ClinicalTrials.gov ID: NCT00426751
Acronym / sponsor ID: 106915
Conditions: Infarction, Myocardial
Keywords: Eptifibatide, ST-elevation Myocardial Infarction, STEMI, Abciximab
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 429 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Oct 2006
Primary completion: Dec 2007 (actual)
Study completion: Dec 2007 (actual)
First posted: 25 Jan 2007 (estimated)
Results: Posted 26 Apr 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Abciximab	Active comparator	Drug: AbciximabIntravenous 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	Experimental	Drug: EptifibatideIntravenous 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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:
Planned primary percutaneous coronary intervention
The subject has given written informed, dated consent to participate in the study

Key exclusion criteria (14 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AbciximabIntravenous 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
EptifibatideAlso: AbciximabIntravenous 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.	Drug	Eptifibatide

Primary outcome

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).
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).

18 secondary outcomes

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)
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)
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)
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)
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 Maximum ST Deviation Existing (Max STE) 60 Min After PCI
Time frame: 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 TIMI 3 Patency of Infarcted Vessels Following PCI
Time frame: after PCI
Mean Number of Corrected TIMI Frame Counts (cTIMI) Following PCI
Time frame: after PCI
Number of Participants With the Indicated Myocardial Blush Grade (TIMI Myocardial Perfusion Grade [TMPG]) After PCI
Time frame: 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
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
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 Died and or Experienced Re-MI Until 6 Months After PCI
Time frame: 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
Number of Participants With Major Bleedings (TIMI Classification)
Time frame: 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
Mean Duration of Stay in the Ward
Time frame: until 6 months after index-MI

Results and safety

Results posted to the registry on 26 Apr 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Eptifibatide	226	204
Abciximab	203	183

Primary outcome: 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). Number. Unit: participants

Measure	Eptifibatide n = 113	Abciximab n = 111
Value	71	65

Eptifibatide vs Abciximab: Median Difference (Final Values): 2.1 (90% CI -8.5 to 12.8)

Population analysed: Per Protocol (PP) Population: All randomized participants who received at least one dose of study drug, who had data that were fully evaluable for the primary endpoint, and who did not show any major protocol violation.

Primary outcome: 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). Number. Unit: participants

Measure	Eptifibatide n = 214	Abciximab n = 196
Value	124	103

Eptifibatide vs Abciximab: Mean Difference (Final Values): 6.8 (95% CI -3.0 to 16.6)

Population analysed: Intent-to-Treat (ITT) Population: All randomized participants who received at least one dose of study medication.

18 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Eptifibatide	24 of 226 (10.6%)	49 of 226 (21.7%)	Not reported
Abciximab	19 of 201 (9.5%)	28 of 201 (13.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 20670755Zeymer 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

24 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Abciximab and Eptifibatide in people with Infarction, Myocardial, run by GlaxoSmithKline at 24 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in France, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Apr 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00426751, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2012.